The Use of Tissue Adhesives for Patients with Traumatic ... Chiu Cheung… · medical care. Traditionally, skin suturing is the only method to achieve wound closure. However, the

Abstract of dissertation entitled

The Use of Tissue Adhesives for Patients with

Traumatic Lacerations in AED

Submitted by

Tsang Chiu Cheung

for the Degree of Master of Nursing

at The University of Hong Kong

in August 2014

Traumatic wounds are one of the most common reasons that people seek emergency

medical care. Traditionally, skin suturing is the only method to achieve wound closure.

However, the procedure can be time consuming and may induce extra pain and distress to

patients. In recent decades, the use of tissue adhesive provides a “needleless” alternative

in laceration wound treatment. This dissertation first synthesizes the available literature to

set up an evidence-based guideline for the use of tissue adhesive for patients with

traumatic lacerations in the accident and emergency department. It then identifies eight

eligible randomized controlled trials for literature appraisal. Based on the evidence, my

project argues that tissue adhesive can reduce wound closure procedure time and pain.

However, due to its relatively high material cost and contraindications, healthcare

professionals should consider using it after balancing the benefits and risks.

To promote the use of tissue adhesive in accident and emergency department, the

dissertation also explores its transferability, feasibility and cost-benefit ratio. Besides, my

work provides an implementation plan to discuss how administrators may promote the

use of this innovation among frontline medical and nursing staff. The dissertation

concludes by reiterating how tissue adhesive can reduce wound closure procedure time

and pain, and alleviate workload of the frontline staff.

The Use of Tissue Adhesives for Patients with

Traumatic Lacerations in AED

by

Tsang Chiu Cheung

BSc (Hons) Nursing (PolyU)

A dissertation submitted in partial fulfillment of the requirement for

the Degree of Master of Nursing

at The University of Hong Kong.

August 2014

i

Declaration

I declare that this dissertation represents my own work, except where due

acknowledgement is made, and that it has not been previously included in a thesis,

dissertation or report submitted to this University or to any other institution for a degree,

diploma or other qualifications.

Signed _________________________

Tsang Chiu Cheung

ii

Acknowledgements

I would like to express my deepest gratitude to Dr Felix Yuen, my dissertation supervisor,

who offered guidance and unfailing support throughout the course of this dissertation.

This project would not have been possible without his patience and critical comments. I

would also like to thank my family, especially my sister, for her constructive suggestions

for my research and writing.

My sincerest thanks finally go to my department supervisors and colleagues, who have

provided me with advice and a supportive environment to complete my dissertation.

Their valuable feedback has further developed my work.

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Table of Contents

Declaration ………………………………………………………………......................... i

Acknowledgements ……………………………………………………………………... ii

Table of contents ……………………………………………………………………….. iii

List of appendices ………………………………………………………………………. vi

CHAPTER 1 – INTRODUCTION

1.1 BACKGROUND ……………………………………………………………………. 1

1.2 AFFIRMING THE NEED ………………………………………………………....... 2

1.3 OBJECTIVES AND SIGNIFICANCE …………………………………………....... 3

CHAPTER 2 – CRITICAL APPRASIAL

2.1 SEARCH AND APPRAISAL STRATEGIES ……………………………………… 5

2.2 RESULTS ………………………………………………………………………….... 6

2.2.1 Search Results ………………………………………………………...... 6

2.2.2 Study Characteristics …………………………………………………... 7

2.2.3 Methodological Quality Assessment …………………………………... 7

2.3 SUMMARY AND SYNTHESIS ………………………………………………….... 9

2.3.1 Subject Population ……………………………………………………... 9

2.3.2 Wound Characteristics ………………………………………………..... 9

2.3.3 Treatments Received ………………………………………………….. 10

2.3.4 Outcome Measures ……………………………………………………. 11

2.3.5 Pain Associated with the Procedure …………………………………... 12

iv

2.3.6 Ease of the Procedure …………………………………………………. 13

2.3.7 Time to Complete the Procedure ……………………………………... 13

2.3.8 Cosmetic Effect ……………………………………………………….. 14

2.3.9 Cost Required for the Treatment ……………………………………… 15

2.3.10 Synthesis of Evidence and Suggestions ……………………………... 16

CHAPTER 3 – TRANSLATION AND APPLICATION

3.1 IMPLEMENTATION POTENTIAL ………………………………………………. 18

3.1.1 Transferability ………………………………………………………… 18

3.1.2 Feasibility ……………………………………………………………... 21

3.1.3 Cost-benefit Ratio of the Innovation ………………………………….. 23

3.2 EVIDENCE-BASED PRACTICE GUIDELINE ………………………………….. 24

CHAPTER 4 – IMPLEMENTATION PLAN

4.1 COMMUNICATION PLAN ……………………………………………………..... 26

4.1.1 Identification of Stakeholders ……………………………………….... 26

4.1.2 Strategies of Change ………………………………………………...... 27

4.2 PILOT PLAN …………………………………………………………………........ 29

4.2.1 Design ……………………………………………………………….... 29

4.2.2 Subjects ……………………………………………………………….. 30

4.2.3 Preparation ……………………………………………………………. 30

4.2.4 Measurements ………………………………………………………… 31

4.2.5 Review of Guideline ………………………………………………….. 31

4.3 EVALUATION PLAN .............................................................................................. 32

4.3.1 Outcome Measurement ……………………………………………….. 32

4.3.2 Nature and Number of Clients to be involved ……………………....... 33

4.3.3 Timing of Taking Measurement …………………………………….... 34

v

4.3.4 Data Analysis ………………………………………………………..... 34

4.3.5 Basis for Adopting the Use of Tissue Adhesive …………………........ 35

CHAPTER 5 – CONCLUSION …………………………………………………….... 36

APPENDICES …………………………………………………………………………. 38

REFERENCES ……………………………………………………………………….... 82

vi

List of Appendices

Appendix 1 – Searching Strategies for Primary Studies .................................................. 38

Appendix 2 –Table of Evidence ...................................................................................... 39

Appendix 3 – Methodological Quality Appraisal ............................................................ 50

Appendix 4 – Cost to the Hospital Authority in wound closure (per person) ................. 70

Appendix 5 – Cost to Hospital Authority in subsequent wound care in AED / GOPD

(per person) ................................................................................................ 70

Appendix 6 – Total cost to the Hospital Authority in wound closure and subsequent

wound care (per person) ............................................................................. 71

Appendix 7 – Wound Care Charges for patient (per person) .......................................... 71

Appendix 8 – Evidence-based Guideline ......................................................................... 72

Appendix 9 – Pediatric Wound Closure Record .............................................................. 80

Appendix 10 – Satisfaction Survey to Healthcare Providers ........................................... 81

1

CHAPTER 1: INTRODUCTION

1.1 Background

Traumatic wounds are one of the most common reasons that people seek emergency

medical care (Holger, Wandersee & Hale, 2004). In the United States in 2001, the

incidence of traumatic lacerations is estimated to be 4 million (Singer, Quinn, Clark &

Hollander, 2002). Traditionally, wound closure has been accomplished by sutures, which

either dissolve after a few days, or to be removed in the following hospital visit. Before

inserting sutures, medical professionals apply local anesthetic agent to reduce pain related

with the procedure. However, patients can feel very painful during the infiltration of

wound with local anesthetic (Singer, Quinn & Hollander, 2008). They generally find it

more challenging to infiltrate wounds in pediatric patients, as the procedure may induce

additional pain, emotional distress and body movements, which complicate the procedure

and take up more time (Osmond, Quinn, Sutcliffe, Jarmuske & Klassen, 1999; Mattick,

Clegg, Beattie & Ahmad, 2002).

Tissue adhesive made from cyanoacrylate have been available in closing simple

lacerations in recent decades. It provides a “needleless” alternative for medical

professionals in handling laceration wounds. It is prepared as liquid monomers that can

quickly form a strong bond over the approximated wound. This fuses the wound edges

together until the wound starts healing (Singer, et al., 2008). Medical professionals

experienced in suturing find tissue adhesive is quick and easy to use following a brief

orientation to the product. At the same time, there are some contraindications in using

2

cyanoacrylate tissue adhesive. Most importantly, it is contraindicated to patients with

infected wound, wounds across mucocutaneous junctions such as lips and oral cavity, or

skin that is regularly exposed to dense hair (for example, scalp) (Ethicon Inc., 2002).

1.2 Affirming the Need

The current wound closure method in local accident and emergency department involves

two methods: conventional suture and adhesive strip. This department does not consider

tissue adhesive for wound closure mainly because of its high material price. In practice,

doctors decide which wound closure method to perform and nurses in the emergency

department are held responsible to perform skin suturing on patients with simple

lacerations. Both pediatric and adult patients receive skin suturing by nurses as there is no

age limit in skin suturing. Such practice has generated a few problems. First,

conventional suturing is relatively time consuming. The whole procedure including

wound preparation, infiltration of local anesthesia and suture usually take 20-30 minutes.

This can affect the manpower support during the time with resuscitation in progress.

Besides, conventional suture can inflict extra pain and distress in patients, especially

during local anesthesia infiltration and suturing procedure. In addition, pediatric suturing

may require additional staff involvement in controlling patients’ movement. Adhesive

strips (Steristrips) are the only non-invasive wound closure material available in the local

setting. It can be applied to small and superficial lacerations. However, it has low tensile

strength, which means it can easily be dropped off from wound. In pediatric patients,

there is also a concern that they may accidentally remove the adhesive strips because of

3

scratching. Therefore, to reduce the risk of adhesive strip dislodgement, doctors prefer

conventional sutures rather than adhesive strips. Lastly, there is a high staff turnover rate

in the last three years, nearly one third of nursing staff are with less than three years

emergency nursing experience. Meanwhile, skin suturing requires nurses to possess

advanced surgical skills that cannot be simply learned from lesson. With limited surgical

skills and experience, performing suture to patients will inflict extra stress on them. As a

result, the suture procedure time may be extended. Most importantly, it may cause more

distress in patients. In summary, current departmental practice leads to increase wound

closure procedure time. Besides, it may inflict extra pain and distress to patients. Lastly,

it may create more stress to nursing staff, which can cause low staff morale.

Previous literatures have shown that tissue adhesives can be used as an alternative of

sutures for some laceration closures. To facilitate the use of tissue adhesives, one should

evaluate the effectiveness of tissue adhesives for patients with traumatic lacerations.

Therefore, the research question will be: How effective are tissue adhesives for patients

with traumatic lacerations? The review below will explore the effectiveness of tissue

adhesives, in terms of pain associated with procedure, ease of procedure, time to

complete the procedure, cosmetic effect and cost required for treatment.

1.3 Objectives and Significance

1. To review the evidence about the effect of tissue adhesives on healing traumatic

lacerations in children and adults

4

2. To develop an evidence-based protocol for nurses on using tissue adhesives on patients

with simple traumatic laceration

3. To assess the transferability and feasibility of implementing the tissue adhesive

protocol in the emergency settings in Hong Kong

5

CHAPTER 2: CRITICAL APPRAISAL

2.1 Search and Appraisal Strategies

Studies were included if:

i. The patients recruited have acute, linear, low tension and traumatic laceration wounds

ii. They were conducted in the emergency settings

iii. They were randomized controlled trials

Studies were excluded if:

i. They were dealing with wounds such as surgical repairs, ulcers, skin grafts, dental

repairs and wounds involving mucocutaneous junctions

Pubmed, Sciencedirect and Proquest were used for primary research. The keywords used

for search are “Tissue adhesive”, “Emergency department”, and “Laceration”. The search

was restricted to randomized controlled trials. Titles and abstracts were checked to

eliminate irrelevant articles. At the same time, duplicated articles were excluded. The

reference lists of eligible studies were also screened for any potential studies which were

not identified previously.

Critical appraisal of all eligible studies was done by using the SIGN Methodology

Checklist for randomized controlled trials (SIGN, 2013). The question statement,

randomization, concealment method, blinding, similarity between groups, validity and

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reliability, drop-out rate, intention to treat analysis and study site comparability were

considered in the quality assessment.

A “++” means the study is of high quality. The score implies the study met most of the

criteria set by the checklist. It also indicates the conclusions of study had a low risk of

bias. A “+” means the study is of acceptable quality. The score shows that the study met

most of the checklist’s criteria. But some flaws in the study were identified and

associated with the risk of bias. However, the overall conclusion of the study would

unlikely be changed. A “0” means the study’s quality is low. The score reveals that the

study could not meet most criteria in the checklist. At the same time, significant flaws

related to study design could be identified. Studies scoring “0” were likely to be rejected

due to high possibility of research bias in the study’s conclusion.

2.2 Results

2.2.1 Search Results

The electronic database search was done between 31th July 2012 and 1

st August 2012.

Appendix 1 summarizes the searching plan and method. After keyword search using

Pubmed, Sciencedirect and Proquest, 23 articles were found. Eight articles were left after

screening the papers’ titles, abstracts and full texts. Two relevant articles were found after

screening the references lists of the eight articles selected before. Eventually, ten studies

were included into the systematic review (Barnett, Jarman, Goodge, Silk & Alckin, 1998;

Holger, et al., 2004; Karcioglu, Goktas, Coskun, Karaduman & Menderes, 2002; Man,

7

Wong, Ng, Lau, Chan, Lopez, Mak, Graham & Rainer, 2009; Mattick, et al., 2002;

Osmond, et al., 1999; Quinn, Wells, Sutcliffe, Jarmuske, Maw, Stiell & Johns, 1998;

Singer, Hollander, Valentine, Turque, McCuskey & Quinn, 1998; Singer, et al., 2002;

Zempsky, Parrotti, Grem & Nichols, 2004).

2.2.2 Study Characteristics

The table of evidence (Appendix 2) summarizes the subject characteristics, number of

subjects, interventions provided, comparison, length of follow up, outcome measures and

effect size.

2.2.3 Methodological Quality Assessment

After completing the SIGN checklist (Appendix 3), four articles score “++” noting high

quality (Man, et al., 2009; Osmond, et al., 1999; Singer, et al., 2002; Zempsky, et al.,

2004). Four articles scored with acceptable “+” (Holger, et al., 2004; Mattick, et al., 2002;

Quinn, et al., 1998; Singer, et al., 1998). Two articles score the unacceptable “0” (Barnett,

et al., 1998; Karcioglu, et al., 2002). All ten selected studies clearly state the research

questions. All studies state that randomization was done in subject allocation and

interventions. However, one study does not clearly report the method of randomization

(Barnett, et al., 1998). Most of the selected articles mention the use of concealment,

whereas three articles did not exactly mention the procedure of concealment (Quinn, et

8

al., 1998; Holger, et al., 2004; Singer, et al., 1998), and two articles did not mention the

concealment method (Barnett, et al., 1998; Karcioglu, et al., 2002). Eight out of ten

articles selected state clearly the blinding method, at the same time, two articles do not

bring up the blinding of subjects and investigators (Barnett, et al., 1998; Karcioglu, et al.,

2002). No studies are double-blinded due to the nature of the interventions (impossible to

insert placebo sutures). Most articles provide sufficient demographic data of research

subjects. One article does not state subjects’ demographic data (Karcioglu, et al., 2002).

Nine articles indicate more male subjects were recruited in the studies. However, only

one study sees such finding as statistically significant (Mattick, et al., 2002). Eight of the

selected articles note a higher percentage of subjects with forehead lacerations recruited

into the studies (Barnett, et al., 1998; Man et al., 2009; Mattick, et al., 2002; Osmond,et

al., 1999; Quinn, et al., 1998; Singer, et al., 1998; Singer, et al., 2002; Zempsky, et al.,

2004). In main research findings, all ten articles use valid and reliable measuring scale to

describe their research findings. Five articles reported low drop-out rate (below 15%)

(Man et al., 2009; Osmond,et al., 1999; Singer, et al., 1998; Singer, et al., 2002; Zempsky,

et al., 2004). Three articles report relatively high drop-out rate in subjects’ one year

follow-up (ranged 17% - 45%) (Holger, et al., 2004; Mattick, et al., 2002; Quinn, et al.,

1998). Two articles did not mention their study drop-out rate (Barnett, et al., 1998;

Karcioglu, et al., 2002). It was found that Mattick et al. (2002) study had relatively small

sample size (n = 60) compared to other studies, and that could be a reason contributing to

the higher drop-out rate (41% and 45% in 1 year follow-up in both intervention groups).

Two studies were carried out in more than one research centers (Man, et al., 2009; Singer,

et al., 2002). After the methodological quality assessment, two articles were rejected due

9

to the lack of research information (Barnett, et al., 1998; Karcioglu, et al., 2002).

Summary and synthesis of ideas based on the remaining eight articles will be illustrated

in next section.

2.3 Summary and Synthesis

2.3.1 Subject Population

It is found that two studies are limited to adult subjects (Man, et al., 2009; Quinn, et al.,

1998), three studies are limited to pediatric subjects (under age 18) (Mattick, et al., 2002;

Osmond, el al., 1999; Zempsky, et al., 2004), and the remaining three articles include

subjects aged ≧ 1 (Holger, et al., 2004; Singer, et al., 1998; Singer, et al., 2002).

2.3.2 Wound Characteristics

All selected studies follow similar criteria in selecting laceration wounds for both

interventions (conventional sutures / tissue adhesives), which exclude lacerations that

resulted from animal/human bite and heavy contamination, and deep sutures around the

hairline or mucus membrane (Man et al., 2009; Holger, et al., 2004; Mattick, et al., 2002;

Osmond,et al., 1999; Quinn, et al., 1998; Singer, et al., 1998; Singer, et al., 2002;

Zempsky, et al., 2004). Three selected studies have only recruited subjects with facial

lacerations (Holger, et al., 2004; Osmond et al., 1999; Zempsky, et al., 2004), while two

studies mention that they focus on subjects with lacerations that require smaller size

10

sutures (such as 5/O monofilament sutures) (Singer, et al., 1998; Singer, et al., 2002). The

remaining three studies do not focus on any specific type or location of laceration wounds

(Man, et al., 2009; Mattick, et al., 2002; Quinn et al., 1998).

The length of wound is also considered in the selected studies. Only Man, et al. (2009)

state the exclusion of subjects with wound length larger than 8cm. Among all eight

studies, the mean length of laceration wound recruited for intervention ranges from 1.5cm

to ~2.5cm (Man et al., 2009; Holger, et al., 2004; Mattick, et al., 2002; Osmond,et al.,

1999; Quinn, et al., 1998; Singer, et al., 1998; Singer, et al., 2002; Zempsky, et al., 2004).

2.3.3 Treatments Received

Four out of eight selected studies compare the cyanoacrylate tissue adhesive to

conventional sutures (Man, et al., 2009; Quinn, et al., 1998; Singer, et al., 1998; Singer,

et al., 2002). Two studies compare cyanoacrylate tissue adhesive to adhesive strips

(Steristrips) (Mattick, et al., 2002; Zempsky, et al., 2004). One study compare

cyanoacrylate tissue adhesive to absorbable and non-absorbable sutures (Holger, et al.,

2002), and one study compare two tissue adhesives (butylcyanoacrylate vs.

octylcyanoacrylate) (Osmond, et al., 1999).

11

2.3.4 Outcome Measures

Cosmetic appearance is the primary outcome reported by all except two selected studies

(Man, et al., 2009; Singer, et al., 2002). All studies incorporated the Cosmetic Visual

Analogue Scale (CVAS), Wound Evaluation Score (WES), or a combination of these 2

measures of cosmetic scores. The timing for cosmetic assessments can be divided into

three periods. First, assessments were done in suture removal and complications follow

up (ranged from 5 to 14 days). Then, second assessments were done during early healing

of wound (ranged from 1 to 3 months). The last assessments were done during late

healing of wound (ranged from 9 to 12 months). Quinn, et al. (1998) suggests that the

cosmetic appearance at the first three months could reliably predict 1-year cosmetic

outcome. Therefore, three studies attempted to limit their study period to three months, so

as to reduce the risk of subjects’ drop out (Man, et al., 2009; Osmond, et al., 1999;

Zempsky, et al., 2004).

The CVAS is a 100mm line, with zero being “the worst scar imaginable” and 100 being

“the best scar imaginable”. Plastic surgeons are usually assigned to be blind assessors. He

or she then rate the appearance of each repaired laceration by observing it directly in

person or from reading standardized photograph. Then, assessors give cosmetic score of

the lacerations by placing a mark along the line. It had been shown that the CVAS is a

reliable and valid outcome measure of long term cosmetic outcome with good inter-rater

agreement (Holger, et al., 2002; Quinn, et al., 1998).

The WES assesses 6 clinical variables of each scar, including the absence of step-off,

contour irregularities, wound margin separation greater than 2mm, edge inversion,

12

excessive distortion, and overall cosmetic appearance (Man, et al., 2009; Quinn, et al.,

1998; Singer, et al., 2002). Each of the six variables scores within a range of 0 to 1, with

the overall score of 6 meaning the wound has optimal cosmetic appearance. A wound

scoring 5 or below means it appears suboptimal (Singer, et al., 2002). Such scoring

method has an advantage of providing detailed feedback of the imperfections that are

generated by a suboptimal scar.

Other than cosmetic outcome, pain associated with procedure, ease of procedure, time to

complete procedure and cost required for treatment are also mentioned.

2.3.5 Pain Associated with the Procedure

Three studies measure pain associated with the procedure by using Visual Analogue

Scale (VAS). None of the studies compare the pain score of tissue adhesive and

conventional suture during the procedure. This is probably due to the fact that the

procedure of conventional suture is more invasive than tissue adhesive. Therefore, the

tissue adhesive is very likely to cause less pain compared to suture. Besides, conventional

suture involves the use of local anesthetics, which may affect the accuracy of pain scored

by research subjects. Two studies compare the pain score of tissue adhesive and adhesive

strips during the procedure. The mean VAS of tissue adhesive is 6.2 (Standard deviation

[SD] = 5.8; 95% confidence interval [CI] 3.0-7.0) and adhesive strip was 9.0 (SD= 5.8;

95%CI 2.0-6.0) (Zempsky, et al., 2004). One study compared the pain induced by the

procedure between two tissue adhesives (butylcyanoacrylate and octylcyanoacrylate), the

13

VAS score was 24 for butylcyanoacrylate and 15 for octylcyanoacrylate respectively (p =

0.37) (Osmond, et al., 1999).

2.3.6 Ease of the Procedure

Among all studies, only Mattick et al. (2002) report the ease of procedure for the

operators. The researchers compare tissue adhesive group and adhesive strips group, and

conclude that it is easier to apply tissue adhesive (p = 0.07 from Mann-Whitney test).

Osmond et al. (1999) report that both butylcyanoacrylate and octylcyanoacrylate tissue

adhesives are easy to use in terms of VAS ease of procedure score (butylcyanoacrylate

mean score = 12mm; octylcyanoacrylate mean score = 15mm).

According to the operators’ comments, using tissue adhesive can reduce the risk of

needle stick injuries to them (Singer, et al., 2002).

2.3.7 Time to Complete the Procedure

Five studies investigate the time required to complete a wound closure. Three studies

compare tissue adhesive with conventional sutures. The results favor tissue adhesive

intervention. Singer et al. (1998) mention that the mean time required for skin closure

alone (not including infiltration of local anesthesia, waiting for anesthesia to develop and

wound cleansing) is 5.98 +/- 6.40 minutes for cyanoacrylate tissue adhesive group and

10.02 +/- 6.90 minutes for the conventional suture group (p = 0.001). Zempsky et al.

14

(2004) compare tissue adhesive with adhesive strips. The mean time for closure is similar

among 2 groups (tissue adhesive 3.0 minutes [SD = 1.9] vs. adhesive strips 3.7 minutes

[SD = 2.1]). Osmond et al. (1999) have found out that the time to repair between

butylcyanoacrylate and octylcyanoacrylate tissue adhesives are similar

(butylcyanoacrylate = 4.2 +/- 3.4 minutes vs. octylcyanoacrylate = 4.0 +/- 3.2 minutes [p

= 0.88]). The results show that the application of tissue adhesives and adhesive strips are

much less time consuming than using conventional sutures.

2.3.8 Cosmetic Effect

All studies measure cosmetic scores by a series of follow up visits. No significant

differences in either CVAS or WES between groups can be identified (tissue adhesive vs.

conventional suture; tissue adhesive vs. adhesive strips; tissue adhesive vs. absorbable

and non-absorbable sutures; butylcyanoacrylate tissue adhesive and octylcyanoacrylate

tissue adhesive). It has been discovered that the CVAS has achieved over 80% in 90 post

wound repair days, which means the cosmetic outcome is good (Holger, et al., 2004; Man,

et al., 2009; Singer, et al., 1998). The WES also notes that over 80% of optimal wound in

90 days follow up, which is similar to the CVAS results (Man, et al., 2009; Mattick, et al.,

2002; Osmond, et al., 1999; Singer, et al., 1998; Singer et al., 2002)

15

2.3.9 Cost Required for the Treatment

Man et al. (2009) mainly focus on the cost difference between tissue adhesive and

conventional suture. According to the data provided by this study, the material cost of

tissue adhesive (Dermabond) is significantly higher than conventional monofilament

suture ($140 for Dermabond vs. $8.25 for monofilament suture [in Hong Kong dollars]).

It has been found out that the mean overall cost to Hong Kong Hospital Authority is

higher in tissue adhesive group ($216.12 +/- 40.92), whether conventional suture group

cost less ($171.33 +/- 39.19) for the whole procedure (Man, et al., 2009). However, the

overall average charges to patients were higher in conventional suture group. This is

because conventional sutures require suture removal and wound dressing during the

wound healing process. In tissue adhesive group, tissue adhesive will automatically

slough off within five to ten days. Therefore, no suture removal cost is needed (Man, et

al., 2009). Singer et al. (2002) also mention the overall costs, including wound repair and

follow up visits, are significantly lower in tissue adhesive group. The reason for this is

derived from the reduction of physician and auxiliary services charges, equipment

charges, and the need for suture removal. Comparing tissue adhesive to adhesive strips, it

has been revealed that tissue adhesive is more expensive in terms of material cost

(Mattick, et al., 2002).

16

2.3.10 Synthesis of Evidences and Suggestions

All reliable studies with SIGN checklist scoring “++” and “+” specify that tissue adhesive

is an acceptable alternative to conventional suture for repairing simple traumatic

lacerations. Studies have illustrated that using tissue adhesive for wound closure can

reduce patients’ pain throughout the procedure. Moreover, tissue adhesives, no matter

what types, are easier to apply compared to conventional sutures and adhesive strips.

Besides, tissue adhesive require less time in skin closure compared to conventional

sutures. At the same time, both adhesive strips and tissue adhesive takes less time in

application. In terms of cosmetic effects, all studies have shown no significant difference

in CVAS and WES between tissue adhesive group and conventional suture group. One

thing to note is that the two rejected studies (SIGN checklist scored “0”) have not

provided the actual values of CVAS, and the drop-out rate among intervention groups

have not been mentioned. Therefore, these two articles are considered as biased. Lastly, it

is clear that the single product cost of tissue adhesive is higher than conventional suture

materials and adhesive strips. However, the overall treatment costs are similar.

In the view of the local setting, using tissue adhesive for wound closure is costly.

However, it can reduce unnecessary pain and suffering in patients. Furthermore, the use

of tissue adhesive can decrease time spent on wound closure procedure, so as to alleviate

the burden of the nursing staff. Tissue adhesive can also provide similar cosmetic effect

as conventional suture does. Because of its ease of use, less time is required to train

junior nurses in the use of tissue adhesive. In addition, Gordon (2001) suggests that using

tissue adhesive could reduce staff needle stick injuries and lower the risk of untoward

17

effects of local anesthesia on patients. Singer et al. (2002) reiterate the same effects. For

many children, the scene of wound closure with suture needle is a worse thought than the

actual injury itself. Tissue adhesive provides a “needleless” solution to this problem.

Whenever the children become calmer, the whole wound closure procedure can be faster.

Also, less manpower is needed to control the child, which can let him / her feel less

distressed. The area to apply tissue adhesive is also a concern. According to daily

experience and previous studies, facial laceration is the most common wound that

required closure. With now more patients and medical professionals concern about the

cosmetic effect of wound closure, tissue adhesive offers an excellent choice for them to

achieve the goal.

Lastly, to adapt tissue adhesive to local needs, we have to allocate resources efficiently to

make a protocol based on Hong Kong’s economic and administrative situation. Therefore,

the proposed protocol will focus on applying tissue adhesive to pediatric patients (under

age 18) with facial laceration. Once the material cost of tissue adhesives are lowered in

the future. The protocol can be extended to wider population.

18

CHAPTER 3: TRANSLATION AND APPLICATION

3.1 Implementation Potential

The review and analysis in Chapter 1 and 2 show how the use of tissue adhesive has

effectively reduced pain in patients with traumatic lacerations in accident and emergency

department. Using tissue adhesive also takes up less time compared to using traditional

skin suture. It also requires less training for healthcare staff to apply tissue adhesive.

However, one has to investigate the implementation potential of tissue adhesive in order

to make sure it can be adapted to local setting. To assess the implementation potential,

one should take into consideration the transferability of findings, feasibility and the cost-

benefit ratio of the use of tissue adhesive (Polit & Beck, 2004).

3.1.1 Transferability

The innovation, which is the use of tissue adhesive, would be implemented in the

accident and emergency department (AED) of an acute hospital in Hong Kong. Patients

in the target setting range from infants to the elderly. Nevertheless, the innovation would

only target patients under eighteen years old who need closure of their traumatic

laceration wound. They would receive tissue adhesive during wound closure instead of

traditional skin closure. The target patient group and setting of the local AED are similar

to the considerations made in the review in chapter 2. Some of the reviewed studies were

conducted in pediatric emergency department, whereas there is no pediatric emergency

department in Hong Kong. Nevertheless, the pediatric patients in our local setting are

19

similar to those recruited in the reviewed studies. The proposed setting in the local AED

is also similar to those in the reviewed studies, which are all conducted in acute hospitals

AEDs.

The philosophy of care of the use of tissue adhesive is consistent to that in the local

setting and the healthcare organization. Nowadays, pain is identified as the fifth vital

signs. Ineffective pain management will increase patient’s sufferings and may interfere

the work of healthcare professionals. Thus, the innovation intends to provide rapid and

less invasive technique to reduce pain during laceration wound closure. Besides, the

target AED is under Kowloon West Cluster (KWC) on the Hospital Authority, which is

the largest and the only government healthcare institute in Hong Kong. The KWC also

puts emphasis on pain management in recent years. It has developed a number of

guidelines and assessment tool for assessing patients’ pain level and pain management.

According to the KWC pain management coordinating committee (2010), the lack of

pain management caused negative impact to patients’ physical and psychological health,

which might eventually increase the burden on healthcare system. Therefore, pain

assessment should be brought into routine practice so as to provide patients with

appropriate care and to enhance patients’ comfort. Healthcare team should also promote

pain management to maintain patients’ wellbeing.

From the data collected in the Hospital Authority Accident and Emergency Information

System of the local AED, there are about 150,000 attendances during the period of

1/1/2013 – 31/12/2013. Among the attendances, 15% were pediatric patients and 5% of

them required laceration wound closure. By calculation, we expect that about 1000

20

pediatric patients would benefit from tissue adhesive each year. The procedure time of

each wound closure is expected to be reduced by 10-15 minutes.

Compared to the reviewed studies, the types of staff responsible for carrying out wound

closure vary in different studies. Some studies have stated that medical officers

performed the wound closure, while some other studies have noted that nurses performed

it. In fact, most of the wound closures done in AEDs were performed by nurses. To

ensure the quality of service, regular trainings and skills workshops were provided to

nurses in order to refresh their skills and knowledge. Most reviewed studies have

suggested that the staff who is responsible for performing wound closure using tissue

adhesive have to be well trained and experienced in basic surgical skills. There are 44

practice nurses in the target AED, 59% of AED nurses (n=26) have over 5 years of

emergency nurse experience. They were well trained in performing traditional skin suture

to patients. Still, it is ideal to ask senior medical officer in AED to hold training sessions

for nurses, as the officer possesses advanced surgical skills. A 1-2 hours workshop can be

provided to nurses about the basic function and characteristic of tissue adhesive. The

nurses would also have a chance to exercise the use of it on dummies.

It would take about eighteen months for the proposed period of the innovation. The

preparation period, guideline and implementation plan development would be completed

in six weeks. The ethical approval would take three to four months in case amendments

are needed. It would take about three weeks in purchasing the tissue adhesives from the

producer, and take around six weeks to train all nurses in using tissue adhesive. The pilot

study and evaluation would be carried out in 3 months. The estimated implementation

21

phase would be 6 months due to unforeseeable number of target patients. Finally, the data

collection, analysis and evaluation would use 2 months to finish.

3.1.2 Feasibility

The autonomy of nurses is crucial to make sure the innovation is feasible in practice

(Polit & Beck, 2004). Compared to other clinical department, AED nurses have more

autonomy in assessing and providing intervention to patients. AED nurses are trained to

offer care to patients who are in life-threatening conditions that requires immediate

interventions. In current practice, they are allowed to administer local anesthesia to

patients during skin suture without doctors’ prescription. It is a common practice in the

target AED because nurses in the target setting have been skilled about basic wound care,

skin suturing and local anesthesia administration. The innovation can allow nurses to

decide whether the wound can be closed by tissue adhesive or not. In early

implementation phase, nurses can seek doctors’ opinions to avoid conflict. It may also

encourage nurses to initiate follow up on patients to assess the recovery of wound. This

allows nurses to provide a more holistic care to patients. Tissue adhesive can also reduce

time spent on wound closure procedure, so as to alleviate the burden of the nursing staff.

They can utilize the time to take care of other patients who requires immediate nursing

care.

Evidence-based practice is a major highlight for the Hospital Authority, the KWC and the

target AED. The e-Knowledge Gateway system developed by the Hospital Authority

22

offers a platform for medical and nursing staff to receive updated evidence-based

knowledge from journal articles and research databases. The e-learning centre and e-

training record database developed by the Hospital Authority and the KWC provide

workshops and training to healthcare staff on clinical knowledge and skills. They can

access the websites on internet, so that they can continue learning at home. In the target

AED, the Chief of Service (COS) and the Department Operation Manager (DOM)

strongly encourage evidence-based clinical practices. Each year, medical and nursing

staff launches numbers of research projects in the department and eventually published in

journal articles. They also believe that each staff has the responsibility to promote

evidence-based innovation in order to provide better care to patients. As a result, the

AED has developed an atmosphere that doctors and nurses are willing to conduct

researches and transfer the evidence-based knowledge into clinical practice. AED

involves various procedures ranged from simple wound dressing to endotracheal tube

intubation. The COS and the consultants always welcome ideas that help to simplify the

workflows of these tasks in order to handle the huge number of attendance. It is also the

concern of nurses about how to handle irritable pediatric patients during wound closure.

For that reason, most of the colleagues should support this new innovation. The use of

tissue adhesive is simple and time-saving. AED nurses have acquired skin-suturing

techniques and do not require complicated training. They should be able to manage the

use of tissue adhesive after a brief introduction and workshop of it.

23

3.1.3 Cost-benefit Ratio of the Innovation

A practical and effective innovation should be cost-effective. Therefore, it is crucial to

investigate the cost-benefit ratio of the innovation. This section will investigate the

benefits, risks and the cost of using tissue adhesive in current practice.

In previous review in Chapter 2, we know that tissue adhesive can reduce pain

throughout the wound closure procedure compared to traditional skin suture. It is also

relatively easy to use and less time consuming. In addition, it provides similar cosmetic

effect as traditional skin suture. However, the reviewed studies mentioned that using

tissue adhesive may have several adverse effects, including wound dehiscence, erythema

and delay wound closure. However, from the evidences obtained in the reviewed studies,

the incident rates of them are very low (Holger, et al., 2004; Singer, et al., 2002;

Zempsky, et al., 2004).

Nursing manpower shortage is an issue that has been discussed for years. Due to the

complexity of the laceration wound closure procedure, nurses have to put this task aside

in case of sudden influx of critical ill patients or overcrowding of AED. Delay wound

closure may lead to serious consequences such as wound infection that requires ward

admission. This leads to increase patients’ suffering and additional workload for nurses.

The situation will remain unchanged if the innovation is not implemented into practice.

Eventually, it will result in increasing healthcare expenses.

Since the innovation is about using tissue adhesive in laceration wound closure, no

additional equipment is required for the intervention. Thus, there will be no set up cost

24

for tissue adhesive. As shown in appendices 4 to 6, the running cost for tissue adhesive is

HK$153.0 per patient. In traditional skin suture, it costs HK$44.1 per patient. The overall

net cost for the Hospital Authority in tissue adhesive is significantly higher than

traditional skin suture. If charges of wound closure and subsequent care on each patient

received by the Hospital Authority are taken into consideration, patients receiving

traditional skin suture had to pay higher charges (HK$179.0 versus HK$100.0)

(Appendix 7).

The costs for nurses to perform wound closure are excluded, because the wound

characteristics, patients’ demographics and nurses’ salaries and skills in wound closure

cannot be standardized. Each wound closure intervention may cost differently.

Comparing the two wound closure methods, we know that tissue adhesive would require

a higher running cost to the Hospital Authority. However, it would favor patients as they

can suffer less pain and pay lower charges for wound closure and subsequent nursing care.

For instance, this innovation can alleviate nurses’ workload and reduce patients’

sufferings. Ultimately, it may help in improving the environment in the AED.

3.2 Evidence-based Practice Guideline

The next stage of the translational research is to develop an evidence-based guideline

according to the evidence obtained in previous review done in Chapter 2 (Polit & Beck,

2008). We adopt the SIGN guideline development methodology to develop the guideline

in the use of tissue adhesive (Scottish Intercollegiate Guidelines Network, 2011). We

25

adopted the Appraisal of Guidelines Research and Evaluation II (AGREE II) Instrument

to evaluate the quality of this guideline (The AGREE Next Steps Consortium, 2013). Due

to time and resources constraints, the guideline does not include patients’ involvement.

Nevertheless, the development of this guideline involves systematic literature review and

synthesis of evidence. Besides, the SIGN 50: A Guideline Developers’ Handbook (2011)

is used to assess the levels of evidence and grades of recommendations. Appendix 8

illustrates the evidence-based guideline and its recommendations.

26

CHAPTER 4: IMPLEMENTATION PLAN

4.1 Communication Plan

As highlighted in the previous chapters, the use of tissue adhesive is highly applicable to

the target clinical setting. However, it has also identified some obstacles that may impede

the implementation of the innovation. It is thus crucial to maintain an organized and

effective communication to the stakeholders, and to establish an evaluation plan

(Registered Nurses Association of Ontario, 2002).

4.1.1 Identification of Stakeholders

Stakeholders can support and influence, or post threats to the implementation of tissue

adhesive. Identification of stakeholders is essential to facilitate the change of clinical

practice (Davis, Goldman & Palda, 2007). The Chief of Service (COS) and the

Department Operation Manager (DOM) in the target Accident and Emergency

Department (AED) are key stakeholders, because they are the medical and nursing

administrators in policy making and resource management. The COS is responsible for

organizing medical staff manpower. Moreover, he would be the one to endorse the

implementation plan and to grant the budget required for the innovation. The DOM

arranges nursing manpower for the innovation implementation. Around one hundred

frontline staff (including medical officers and nurses) is the stakeholder as well because

they are the users of tissue adhesive, which is the material used for the innovation. These

frontline staff are also innovation program conductors, as they perform wound closure to

27

patients. The three main parties’ input helps develop a practical guideline for the

innovation.

4.1.2 Strategies of Change

Communication between stakeholders fosters the effective use of tissue adhesive. The

target AED had recently established the Accident and Emergency Nurse Practitioner

(AENP) service. Three APNs who have received training are now responsible to handle

patients with minor injuries including those with simple laceration wounds. Besides, they

advise nursing colleagues about the latest practice in dealing with patients with minor

injuries. Therefore, they can take up the role as program coordinators and help publicize

the proposal. In the first week of preparation, the AENPs would raise the proposed issues

with the APNs during the tea breaks, meal breaks and informal meetings. They would

mention the need of change, the benefits and risks of the proposed new innovation. After

persuading the APNs, the AENPs would raise the issue to the COS and the DOM during

the monthly AENP evaluation meeting. One of the target hospital’s missions is to adopt

innovations to improve patient care. Thus, the proposal should be acceptable at the

hospital policy level. As mentioned in Chapter 3, the COS and the DOM strongly

encourage evidence-based clinical practice. Based on the review of evidence, the

innovation is effective and can benefit patients and nurses. The innovation therefore

should gain their attention. The AENPs would then discuss the details of the

implementation, pilot test and evaluation plan to the APNs, the COS and the DOM during

a formal departmental management meeting.

28

Apart from alerting the APNs and administrators of the use of tissue adhesive, the

AENPs could inform frontline staff of this innovation by emails and departmental

trainings. They could raise concerns about the alternative methods in laceration wound

closure to doctors and nurses through informal discussions or during daily handover

period. A communication team would be formed by the DOM, the COS, the AENPs and

three frontline nurse representatives. This team promotes the innovation to all frontline

staff, including doctors and nurses. The team members would hold introductory talks

during monthly journal club meeting session. A poster designed by the team would be

posted in the staff pantry to promote the innovation. The ethical committee of the target

hospital is expected to take about a month to approve the innovation implementation plan.

During that period, the AENPs and the nurse representatives in the communication team

will receive training about the use of tissue adhesive. They will be assigned to train the

frontline staff during the pilot phase. The proposal would be revised after gaining all

stakeholders’ opinions. Once the COS and the DOM approved the revised proposal, it

would be sent to the ethical committee for pilot test approval. The ethical approval

process will take about two months.

To ensure the use of tissue adhesive is sustainable in the target clinical setting, the APN

who deals with the daily handover would help to promote it during the handover time.

This will be done in the first two weeks of the pilot and implementation period.

Reminders will be posted in the minor operation theatre in the target AED to encourage

the frontline staff to use tissue adhesive for laceration wound treatment during the pilot

and implementation phase. The assigned trainers would also produce a video guide about

the use of tissue adhesive in wound closure. The video guide will be uploaded on to the

29

department webpage. Before the implementation phase, all frontline staff who is eligible

to perform wound closure will receive a short revision workshop. This aims to refresh

their knowledge about the use of tissue adhesive. Once the implementation phase begins,

frontline staff will receive user guide and opinion sheet about the use of tissue adhesive

through email. Hard copies of the documents are also available in the AED minor

operation theatre. They allow frontline staff to express their opinion and give suggestions

regarding to the use of tissue adhesive.

4.2 Pilot Plan

Pilot test is one of the core components of using tissue adhesive. It evaluates the

adhesive’s feasibility. It is a small-scale trial of the implementation in testing the study

guideline and data collection method. Another issue of the pilot plan is to collect staffs’

opinions about the innovation. This helps to revise the guideline for further use in the

implementation phase of the project.

4.2.1 Design

The pilot plan would last twelve weeks, including a two-week training period for

frontline staff, four-week control period, four-week intervention period and two-week

amendment period. During the control period, nurses would carry out laceration wound

closure by conventional suturing according to existed guideline. In the intervention

30

period, trained nurses would carry out the intervention (closure of laceration wound by

tissue adhesive) according to the proposed guideline.

4.2.2 Subjects

As aforementioned, the inclusion and exclusion criteria of subjects for both control and

intervention period would be the same. All pediatric patients who are below eighteen

years old and require wound closure for acute, linear, low tension and traumatic facial

laceration wound would be included. Patients with wounds involving surgical repairs and

mucocutaneous junctions would be excluded. Around 60 subjects would be recruited into

the pilot study.

4.2.3 Preparation

Before the start of the pilot phase and implementation phase of tissue adhesive, the ward

manager would invite tissue adhesive salesmen to introduce and provide training to the

AENPs and frontline nurse representatives who are assigned as trainers. Both the pilot

and implementation period require approximately 100 packs of tissue adhesives. They

will be purchased by department funding. Within 2 weeks after the initial training, the

trainers will hold training workshops for frontline staff when they are on duty. The

training is based on knowledge and skills in using tissue adhesive. Moreover, frontline

staff will receive information about the implementation guideline, measuring instrument

and method of data collection.

31

4.2.4 Measurements

The procedure nurse would assess patients’ pain score soon after wound closure

procedure in both control and intervention period. A data collection form is designed to

collect patients’ data (Appendix 9). The data comprises patients’ sex, age, size of

laceration wound, pain score and time required for the procedure. The study adopts the

Kowloon West Cluster (KWC) pain assessment tool, which combines Visual Analogue

Scale (VAS), Numerical Rating Scale (NRS) and Wong-Baker Faces Pain Rating Scale

(WBFS) (Hospital Authority, Kowloon West Cluster, 2012). For patients who do not

have enough verbal skills to express their pain score, the procedure nurse can use WBFS

as pain assessment tool (Garra, Singer, Taira, Chohan, Cardoz, Chisena & Thode Jr,

2010).

Completed data collection form about tissue adhesive would be collected using the box in

the minor operation theatre. The trainers would perform regular audit to maintain the

quality of practice. During pilot test period, frontline staff is strongly encouraged to

provide feedback and suggestions using the opinion sheet provided. Members of the

trainers and communication team are also welcome to advise on the study.

4.2.5 Review of Guideline

The COS, DOM, AENPs and frontline nurse representatives will form a review panel of

tissue adhesive after finishing the pilot test. All data collection forms, audit memos and

opinion sheet from staff will be collected. They would hold review meetings to

32

investigate potential problems related to the workflow and data collection. They would

also study the opinion sheet from frontline users and audit memos from trainers to

identify the concerns and advices about the innovation and seek improvement. As

mentioned in the pilot plan design, the amendments are expected to be done within 2

weeks. The reviewed guideline will be sent to hospital ethical committee for ethical

approval before starting the implementation phase. Before initiating the implementation

phase, all frontline staff would receive training based on the amended guideline through

training workshop. The training is expected to finish in two weeks.

4.3 Evaluation Plan

It is important to evaluate whether the use of tissue adhesive is effective and sustainable.

Therefore, the following will discuss the outcome measurement, the nature and number

of clients to be involved, the timing of taking measurements, data analysis and the basis

for adopting the innovation (use of tissue adhesive).

4.3.1 Outcome Measurement

The primary outcome of using tissue adhesive is to explore if the proposal would reduce

patients’ pain score. As noted in the pilot plan, the nurse who is responsible for wound

closure would measure patients’ pain score with the KWC pain assessment tool. The pain

score is documented in the pediatric wound closure record (Appendix 9). The KWC pain

33

assessment tool includes the VAS, NRS and WBFS. Several studies have proven that

they are reliable and valid in measuring pain score in pediatric patients (Bosenberg,

Thomas, Lopez, Kokinsky & Larsson, 2003; Garra, et al., 2010; Ramelet, Rees,

McDonald, Bulsara & Huijer Abdul-Saad, 2007).

The secondary outcome would be reducing the time to close the wound. The procedure

nurse would count the time required for wound closure using tissue adhesive and marked

into the pediatric wound closure record. One of the members from the research group

would extract data for analysis.

Another outcome would be frontline staff’s satisfaction about the tissue adhesive. A self-

reported survey (Appendix 10) is designed to collect staff satisfaction. The survey

contains five questions with 5-point likert scale. The scores ranged from 1 (strongly

disagree) to 5 (strongly agree). The mean score of all five questions represent the final

score of the survey. A higher score means the frontline staff feels more satisfied with the

innovation. The pediatric wound closure record would also collect patients’ demographic

data including sex and age.

4.3.2 Nature and Number of Clients to be involved

As discussed before, all pediatric patients who are below eighteen years old and require

wound closure for acute, linear, low tension and traumatic facial laceration wound would

be included. Patients with wounds including surgical repairs and mucocutaneous

junctions would be excluded.

34

Several studies have concluded that a minimum reduction of ten millimeters in VAS

(corresponding to one unit in the KWC pain assessment tool) is considered to be a

significant effect of the use of tissue adhesive (Man, et al., 2009; Mattick, et al. 2002;

Quinn, et al. 1998). For the sample size, assuming the standard deviation is 3 units; the

effect size is 0.8, power is 0.9 and alpha is 0.05, the estimated sample size calculated is

87. From the data collected in the Accident and Emergency Information System, there are

1037 eligible subjects per year. Therefore, it takes five weeks to provide treatment for a

minimum period of five weeks is needed to 87 subjects. In reality, subjects’ dropout and

missing data may affect data analysis. As a result, the intervention period can be extended

to twelve weeks. The study could provide treatment for 239 subjects.

4.3.3 Timing of Taking Measurements

The primary outcome (pain score) would be measured soon after each wound closure

procedure. For the secondary outcome (time to complete the procedure) and frontline

staff’s satisfaction, the data would be collected once the implementation phase is

completed.

4.3.4 Data Analysis

Once the nurse has used the tissue adhesive to close wounds on patients, IBM SPSS 22.0

will analyze the data collected. The demographic data of study subjects will be

summarized by descriptive statistics. For the primary outcome, a two-tail paired t-test is

35

used to determine whether the pain score is reduced in the intervention group (tissue

adhesive) compared to the control group (conventional suture). For the secondary

outcome, a two-tailed paired t-test is used to find out whether the time to complete wound

closure is reduced in the intervention group compared to the control group. The staff

satisfaction of the innovation is estimated with 95% confidence interval.

4.3.5 Basis for Adopting the Use of Tissue Adhesive

Once the evaluation is finished, the AENPs, frontline nurse representatives will hold

meetings with the COS and the DOM to evaluate the use of tissue adhesive. The

statistical findings in primary and secondary outcomes of the use of tissue adhesive in

laceration wound closure determine the innovation’s effectiveness. For the primary

outcome, the pediatric patients are expected to receive less pain (a minimum reduction of

one unit in the KWC pain assessment tool) in using tissue adhesive as wound closure

material. Meanwhile, the use of tissue adhesive is estimated to reduce 15% of wound

closure procedure time. For staff satisfaction towards the use of tissue adhesive, the mean

score should be at least over three points out of the 5-point likert scale, which means they

support the use of tissue adhesive. The use of tissue adhesive in wound closure, as

demonstrated above, could reduce pain in patients on the one hand, and reduce wound

closure procedure time on the other. With fervent support by frontline staff, target AED

should undoubtedly take this innovation into consideration.

36

Chapter 5: CONCLUSION

In summary, this translational study has explored the use of tissue adhesive for patients

with traumatic laceration in AED, especially targeting pediatric patients (under aged 18)

with facial laceration. Various studies (Mattick, et al., 2002; Osmond, et al., 1999;

Zempsky, et al., 2004) have demonstrated that conventional suture is more invasive and

inflicts more pain to patients. This may prolong the wound closure procedure time. With

a shortage of manpower, it would increase the workload of healthcare staff and worsen

the service quality in the long run. Evidences from the reviewed studies have identified

tissue adhesive as an alternative that causes less pain and minimizes time in laceration

wound closure.

In current practice, adhesive strips are the only alternative for conventional suture.

However, it is not widely used due to its low tensile strength. Using tissue adhesive can

solve this problem, and offer a “needleless” option for laceration wound closure. The

goal of using tissue adhesive is to reduce patients’ pain and wound closure time.

Before implementing the use of tissue adhesive in local setting, this study has

demonstrated that the innovation is highly transferrable, feasible and cost-effective. It

thus has developed an evidence-based practice guideline in the use of tissue adhesive for

pediatric patients with facial lacerations. The guideline is to be adopted in AED in one of

the local hospitals. Chapter 4 of this study has discussed the communication plan, pilot

testing and evaluation plan for performing the proposed practice.

37

In general, conventional suture is still most commonly used for wound closure in Hong

Kong. But this dissertation has thoroughly proven that using tissue adhesive in laceration

wound closure can reduce patients’ sufferings and medical and nursing staffs’ workload.

I hope that technological advancement can gradually reduce the cost of producing tissue

adhesives to benefit more patients and medical staff.

38

Appendices

Appendix 1: Searching Strategies for Primary Studies

39

Appendix 2: Table of Evidence

Bibliographic citation Study type

Ev lev

Number of patients

Patient characteristics Intervention Comparison Length of follow up

Outcome measures

Effect size Source of funding

Barnett, P., Jarman, F.C., Goodge, J., Silk, G. & Alckin, R.,(1998). Randimised Trial of Histoacryl Blue Tissue Adhesive Glue Versus Suturing in the Repair of Pediatric Lacerations. Journal of Paediatric Child Health, 34, 548-550.

RCT - Baseline= 163, tissue adhesive =83, suture =80

Patient aged 4 years or older with clean laceration on any part of the body

Exclude patients with wounds involving eyelid, mucous membrane or joint margins (under added tension)

Closure of lacerations using tissue adhesive / suture

Time to repair the wound, pain experienced during the procedure and cosmetic outcome between tissue adhesive group and suture group

1 year Difference of time to repair the wound, pain experienced during the procedure and cosmetic outcome between tissue adhesive group and suture group

Time to repair the wound: tissue adhesive = 0-2 minutes vs suture = 6-10 minutes (p=<0.001)

Pain experienced during the procedure: tissue adhesive =18.7 (SD=21.8) vs suture = 33.6 (SD=27.3) (p=<0.001)

Cosmetic outcome: tissue adhesive vs suture = no differences (inter-observer reliability = 0.84)

Not stated

General comments: Tissue adhesive is faster and less painful than suturing. Besides, tissue adhesive has similar cosmetic result as suturing when used for repairing simple lacerations in children.

40


Ev lev

Number of patients


Outcome measures


Holger, J.A., Wandersee, S.C.& Hale, D.B.. (2004). Cosmetic Outcomes of Facial Lacerations Repaired with Tissue-Adhesive, Absorbably, and Nonabsorbable Sutures. American Journal of Emergency Medicine, 22(4), 254-257.

RCT + Baseline=230, patients randomized =150 , dropouts=5, nylon suture= 49, tissue adhesive=49, rapid-absorbing gut suture=47

Patients with age 5 years and older with facial lacerations attended emergency department

Exclude patients with bite/ crushed wounds / immunocompromised

Wound closure using tissue adhesive / nylon sutures / rapid-absorbing gut suture

VACS score of scar between nylon suture, tissue adhesives and rapid-absorbing gut suture

1 year Difference between VACS score between tissue adhesive, nylon suture and rapid-absorbing gut suture

VACS score in nylon suture =77.1 (reviewer A) (p=0.65), 88.0 (reviewer B) (p=0.79) vs tissue adhesive=77.2 (reviewer A) (p=0.65), 86.0 (reviewer B) (p=0.79) vs rapid-absorbing gut suture = 73.6 (reviewer A) (p=0.65), 88.7 (reviewer B) (p=0.79)

Not stated

General comments: there is no difference between cosmetic outcomes at 9-12 months in patients with facial lacerations closed with nylon suture, tissue adhesives and rapid-absorbing gut suture

41


Ev lev

Number of patients


Outcome measures


Karcioglu, O., Goktas, N., Coskun, F., Karaduman, S.& Menderes, A. (2002). Comparison of Tissue Adhesive and Suturing in the Repair of Lacerations in the Emergency Department. European Journal of Emergency Medicine, 9, 155-158.

RCT - Baseline= 52, tissue adhesive =24, suture =28

Patients with lacerations less than or equal to 5cm

Exclude patients with systemic diseases such as diabetes mellitus, human / animal bite, crushed and infected wounds, wounds around joints or high-tension areas and wounds crossing mucocutaneous borders


VAS score of healing scar, cost of procedure and patient and physician satisfaction of procedure between tissue adhesive group and suture group

3 months Difference of VAS score of healing scar, cost of procedure and patient and physician satisfaction of procedure between tissue adhesive group and suture group

VAS score of healing scar: tissue adhesive = 7.7 vs suture = 6.3 (p=0.068)

Cost of procedure: tissue adhesive = ~$20 vs suture = $40 (p=0.000)

Patient satisfaction of procedure: tissue adhesive = 95.8% satisfied vs suture = 43.9% (p=0.007)

Physician satisfaction of procedure: tissue adhesive = 63.2% vs suture = 36.8% (p= 0.000)

Not stated

General comments: Histoacryl Blue tissue adhesive is a cost-effective alternative to conventional suturing for simple lacerations in the emergency department

42


Ev lev

Number of patients


Outcome measures


Man, S.Y., Wong, E.M.L., Ng, Y.C., et al. (2009). Cost-Consequence Analysis Comparing 2-Octyl Cyanoacrylate Tissue Adhesive and Suture for Closure of Simple Lacerations: A Randomized Controlled Trial. Annals of Emergency Medicine, 53(2), 189-197.

RCT + Baseline= 186, 2-octyl Cyanoacrylate tissue adhesive =93, suture=93

Patients attend ED with a single traumatic laceration or incised wound

Closure of lacerations using 2-octyl Cyanoacrylate tissue adhesive / suture

Overall cost of treatment + follow-up between the group using 2-octyl Cyanoacrylate tissue adhesive and suture

3 months Difference between the overall cost of treatment+ follow-up between the group using 2-octyl Cyanoacrylate tissue adhesive and suture

CVAS score baseline: tissue adhesive=60.8 vs suture=62.3 (absolute difference=1.5)

CVAS score day 90: tissue adhesive = 92.5vs suture =85.4 (absolute difference =7.1)

Hospital Authority

General comments: high material cost of tissue adhesive cannot be offset by the lower cost of subsequent care in traditional suture. However, tissue adhesive can significantly reduce procedure time than suture. Moreover, tissue adhesive is more convenient to use.

43


Ev lev

Number of patients


Outcome measures


Mattick, A., Clegg, G., Beattie, T., et al. (2002). Randomised, Controlled Trial Comparing a Tissue Adhesive (2-octylcyanoacrylate) with Adhesive Strips (Steristrips) for Paediatric Laceration Repair. Emergency Medicine Journal, 19(5), 405-407.

RCT + Baseline=60, tissue adhesive=30, steristrip=30

Children aged 1-14 year of age with suitable laceration (not greater than 5cm, not infected, not involved mucus membrane)

Wound closure using tissue adhesive / steristrip

Distress level indicated by VAS after treatment

Cosmetic appearance of scar judged by plastic surgeon

12 months

Difference between VAS score between tissue adhesive and steristrip

Difference between cosmetic appearance of scar

VAS score in tissue adhesive =91 vs steristrip=95 (p=0.07)

Cosmetic appearance of scar: tissue adhesive=87 vs steristrip=87 (p=0.81)

Not stated

General comments: both tissue adhesive and steristrip can significantly reduce distress level of children during the procedure. Also, both of them provide excellent cosmetic effect.

44


Ev lev

Number of patients


Outcome measures


Osmond, M.H., Quinn, J.V., Sutcliffe, T., et al. (1999). A Randomized, Clinical Trial Comparing Butylcyanoacrylate with Octylcyanoacrylate in the Management of Selected Pediatric Facial Laceration. Academic Emergency Medicine, 6(8), 171-177.

RCT ++ Baseline= 124, randomized = 94, butylcyanoacrylate =47, octylcyanoacrylate =47

Patients less than 18 years old with traumatic facial lacerartion attended ED

Exclude patients with contaminated wound, human / animal bites, scratch/puncture/crush wound

Closure of lacerations using butylcyanoacrylate tissue adhesive /octylcyanoacrylate tissue adhesive

VAS cosmesis score, time of repair, VAS pain score between butylcyanoacrylate and octylcyanoacrylate

3 months Difference between the VAS cosmesis score between the group using butylcyanoacrylate and octylcyanoacrylate 3 months after intervention

Difference between time of repair and VAS pain score between the group using butylcyanoacrylate and octylcyanoacrylate

VAS cosmesis score butylcyanoacrylate = 70mm vs octylcyanoacrylate = 67.5mm (p=0.84)

Time of repair: butylcyanoacrylate = 4.2 (+-3.4)min vs octylcyanoacrylate = 4.0 (+-3.2)min (p=0.88)

VAS pain score: butylcyanoacrylate = 24(6,33)mm vs octylcyanoacrylate = 15 (2,39)mm (p=0.37)

Not stated

General comments: in the closure of small linear pediatric facial lacerations, octylcyanoacrylate is similar to butylcyanoacrylate in ease of use and early and late cosmetic outcomes

45


Ev lev

Number of patients


Outcome measures


Quinn, J., Wells, G., Sutcliffe, T., et al. (1998). Tissue Adhesive Versus Suture Wound Repair at 1 Year: Randomized Clinical Trial Correlating Early, 3-Month, and 1-Year Cosmetic Outcome. Annals of Emergency Medicine, 32(6), 645-649.

RCT + Baseline= 136, octyl Cyanoacrylate tissue adhesive =68, suture=68

Patients attend AED with a sustained traumatic laceration requiring suture (including deep sutures), not included patients with pregnancy, contaminated wound, or animal bite wound, etc.

Closure of lacerations using octyl Cyanoacrylate tissue adhesive / suture

Wound score of repaired wound in 3-5 days post repair, 10 days post repair, 3 months post repair and 1 year post repair

1 year Difference between the wound evaluation score and visual analog cosmetic score between the group using octyl Cyanoacrylate tissue adhesive and suture

Visual analog cosmetic score tissue adhesive=69 (+/-19.6) vs suture=69 (+/-14.3)

1 year wound evaluation scores (optimal wound percentage) octylcyanoacrylate tissue adhesive= 73% vs sutures= 68%

Not stated

General comments: no difference is noted in the cosmetic outcomes of traumatic lacerations treated with tissue adhesive and sutures. The assessment of wound 3 months post injury and wound repair provides a good measure of long term cosmetic outcomes

46


Ev lev

Number of patients


Outcome measures


Singer, A.J., Hollander, J.E., Valentine, S.M. et al.,(1998). Porspective, Randomized, Controlled Trial of Tissue Adhesive (2-Octylcyanoacrylate) vs Standard Wound Closure Technique for Laceration Repair. Academic Emergency Medicine, 5(2), 94-99.

RCT + Baseline= 124, tissue adhesive =63, suture =61

Patient older than 1 year of age attended ED with traumatic laceration

Exclude patients with multiple trauma, previously diagnosed peripheral vascular disease/ insulin-dependent diabetes mellitus, known history of keloid formation / scar hypertrophy, wound caused by human/ animal bite, crush injuries, wound involved mucous membrane


VAS cosmetic score, time of repair, physician assessments of cosmetic appearance between octylcyanoacrylate tissue adhesive group and suture group

3 months Difference between VAS cosmetic score, time of repair, physician assessments of cosmetic appearance between octylcyanoacrylate tissue adhesive group and suture group

VAS cosmesis score: tissue adhesive = 83.8(+-19.4)mm vs suture = 82.5(+-17.6)mm (p=0.72)

Mean time of repair: tissue adhesive =5.98 (+-6.40)minutes vs suture = 10.02(+-6.90)minutes (p=0.001)

Physician assessments of cosmetic appearance: tissue adhesive =77% vs suture = 80% (p=0.67)

Not stated

General comments: wounds treated with octylcyanoacrylate and standard wound closure techniques have similar cosmetic appearances 3 months post repair

47


Ev lev

Number of patients


Outcome measures


Singer, A.J., Quinn, J.V., Clark, R.E.& Hollander, J.E. (2002). Closure of Lacerations and Incisions with Octylcyanoacrylate: a Multicenter Randomized Controlled Trial. Surgery, 131(3), 270-276.

RCT ++ Baseline=814 patients, tissue adhesive=406, suture=408

Patients with traumatic laceration or skin incision that requires wound closure


Mean time and dehiscence percentage between tissue adhesive and suture 5-10days and 3 months follow up comparing: - wound infection rate - irregular wound healing - dehiscence rate

3 months Difference between mean time of skin closure, dehiscence percentage, and the poor overall appearance percentage in 3 months follow up

Mean time of skin closure:

Tissue adhesive=2.9 minutes vs. suture=5.2 minutes (p=<0.001)

3 months follow-up WES optimal wound percentage

Tissue adhesive = 82% vs. suture = 83.1% (p= 0.67)

Not stated

General comments: tissue adhesive significantly reduce procedure time compared to suture. And the 3-months cosmetic outcome is similar between tissue adhesive and suture.

48


Ev lev

Number of patients


Outcome measures


Zempsky, W.T., Parrotti, D., Grem, C., et al. (2004). Randomized Controlled Comparison of Cosmetic Outcomes of Simple Facial Lacerations Closed With SteriStrip, Skin Closures or Dermabond Tissue Adhesive. Pediatric Emergency Care, 20(8), 519-524.

RCT ++ Baseline=100 patients, 3 protocol violation. tissue adhesive=49, steri strip=48

Patients aged between 1-18 years attended pediatric emergency department with facial laceration that requires wound closure (excluded those with deep lacerations and grossly contaminated wound)

Closure of lacerations using tissue adhesive / steri strip

Pain associated with wound closure and cosmetic outcome of repaired wound 2 months after wound closure

2 months Difference between pain rating during procedure, cosmetic rating of scar in 2 months follow up, incidence of wound infection and dehiscence between tissue adhesive group and steri strip group

Mean pain rating during procedure tissue adhesive =6.2 (SD = 5.8) vs steristrip= 9.0 (SD =15.3)

2 months cosmetic rating tissue adhesive= 43.8 (mean) vs steri strip = 37.2(mean)

3M Inc.

General comments: steri strip skin closures and tissue adhesive provides similar cosmetic outcomes for closure of simple facial lacerations.

Abbreviations

CVAS = Cosmetic Visual Analogue Scale

ED = Emergency department

RCT = Randomized controlled trial

SD = Standard deviation

VACS = Visual Analogue Cosmetic Scale

VAS = Visual Analogue Scale

49

List of articles

1. Barnett, P., Jarman, F.C., Goodge, J., Silk, G. & Alckin, R.,(1998). Randimised Trial of Histoacryl Blue Tissue Adhesive Glue Versus Suturing in the Repair of Pediatric Lacerations. Journal of Paediatric Child Health, 34, 548-550.

2. Holger, J.A., Wandersee, S.C.& Hale, D.B.. (2004). Cosmetic Outcomes of Facial Lacerations Repaired with Tissue-Adhesive, Absorbably, and

Nonabsorbable Sutures. American Journal of Emergency Medicine, 22(4), 254-257.

3. Karcioglu, O., Goktas, N., Coskun, F., Karaduman, S.& Menderes, A. (2002). Comparison of Tissue Adhesive and Suturing in the Repair of

Lacerations in the Emergency Department. European Journal of Emergency Medicine, 9, 155-158.

4. Man, S.Y., Wong, E.M.L., Ng, Y.C., et al. (2009). Cost-Consequence Analysis Comparing 2-Octyl Cyanoacrylate Tissue Adhesive and Suture

for Closure of Simple Lacerations: A Randomized Controlled Trial. Annals of Emergency Medicine, 53(2), 189-197.

5. Mattick, A., Clegg, G., Beattie, T., et al. (2002). Randomised, Controlled Trial Comparing a Tissue Adhesive (2-octylcyanoacrylate) with

Adhesive Strips (Steristrips) for Paediatric Laceration Repair. Emergency Medicine Journal, 19(5), 405-407.

6. Osmond, M.H., Quinn, J.V., Sutcliffe, T., et al. (1999). A Randomized, Clinical Trial Comparing Butylcyanoacrylate with Octylcyanoacrylate

in the Management of Selected Pediatric Facial Laceration. Academic Emergency Medicine, 6(8), 171-177.

7. Quinn, J., Wells, G., Sutcliffe, T., et al. (1998). Tissue Adhesive Versus Suture Wound Repair at 1 Year: Randomized Clinical Trial Correlating

Early, 3-Month, and 1-Year Cosmetic Outcome. Annals of Emergency Medicine, 32(6), 645-649.

8. Singer, A.J., Hollander, J.E., Valentine, S.M. et al.,(1998). Porspective, Randomized, Controlled Trial of Tissue Adhesive (2-

Octylcyanoacrylate) vs Standard Wound Closure Technique for Laceration Repair. Academic Emergency Medicine, 5(2), 94-99.

9. Singer, A.J., Quinn, J.V., Clark, R.E.& Hollander, J.E. (2002). Closure of Lacerations and Incisions with Octylcyanoacrylate: a Multicenter

Randomized Controlled Trial. Surgery, 131(3), 270-276.

10. Zempsky, W.T., Parrotti, D., Grem, C., et al. (2004). Randomized Controlled Comparison of Cosmetic Outcomes of Simple Facial Lacerations

Closed With SteriStrip, Skin Closures or Dermabond Tissue Adhesive. Pediatric Emergency Care, 20(8), 519-524.

50

Appendix 3: Methodological Quality Appraisal

S I G N

Methodology Checklist 2: Controlled Trials

Barnett, P., Jarman, F.C., Goodge, J., Silk, G. & Alckin, R.,(1998). Randomised Trial of Histoacryl Blue Tissue Adhesive Glue Versus Suturing in the Repair of Pediatric Lacerations. Journal of Paediatric Child Health, 34, 548-550.

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly

focused question

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups

is randomised.

Yes

Can’t say

No

1.3 An adequate concealment method is used.

Yes

Can’t say

No

1.4 Subjects and investigators are kept ‘blind’ about

treatment allocation.

Yes

Can’t say

No

1.5 The treatment and control groups are similar at the

start of the trial.

Yes

Can’t say

No

1.6 The only difference between groups is the treatment

under investigation.

Yes

Can’t say

No

1.7 All relevant outcomes are measured in a standard,

valid and reliable way.

Yes

Can’t say

No

1.8 What percentage of the individuals or clusters

recruited into each treatment arm of the study

dropped out before the study was completed?

Not mentioned

51

1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).

Yes

Can’t say

No

Does not

apply

1.10 Where the study is carried out at more than one site,

results are comparable for all sites.

Yes

Can’t say

No

Does not

apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code as follows:

High quality (++)

Acceptable (+)

Unacceptable – reject 0

2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?

No

2.3 Are the results of this study directly

applicable to the patient group

targeted by this guideline?

Not sure

2.4 - No information about blinding and concealment was provided

- No information about dropout rate mentioned

- No numerical descriptions about the cosmetic outcome between 2

experimental group were mentioned

52

S I G N


Holger, J.A., Wandersee, S.C.& Hale, D.B.. (2004). Cosmetic Outcomes of Facial Lacerations Repaired with Tissue-Adhesive, Absorbable, and Nonabsorbable Sutures. American Journal of Emergency Medicine, 22(4), 254-257.




focused question.

Yes

Can’t say

No


is randomised.

Yes

Can’t say

No


Yes

Can’t say

No



Yes

Can’t say

No


start of the trial.

Yes

Can’t say

No



Yes

Can’t say

No



Yes

Can’t say

No

53




Nylon suture group =

43%

Octylcyanoacrylate

group = 45%

Rapid-absorbing gut

suture group = 38%


Yes

Can’t say

No

Does not

apply



Yes

Can’t say

No

Does not

apply



High quality (++)

Acceptable (+)



Yes




Yes

2.4 - There is no difference between cosmetic outcomes at 9-12 months in

patients with facial lacerations closed with nylon suture, tissue adhesives

and rapid-absorbing gut suture

- Relatively high dropout rate in all 3 study groups in 9-12-month follow up

- Not much information about concealment method was mentioned

54

S I G N


Karcioglu, O., Goktas, N., Coskun, F., Karaduman, S. & Menderes, A. (2002). Comparison of Tissue Adhesive and Suturing in the Repair of Lacerations in the Emergency Department. European Journal of Emergency Medicine, 9, 155-158.




focused question.

Yes

Can’t say

No


is randomised.

Yes

Can’t say

No


Yes

Can’t say

No



Yes

Can’t say

No


start of the trial.

Yes

Can’t say

No



Yes

Can’t say

No



Yes

Can’t say

No




Not mentioned

55


Yes

Can’t say

No

Does not

apply



Yes

Can’t say

No

Does not

apply



High quality (++)

Acceptable (+)



Not sure, as the study may over-estimate the effect of tissue adhesive




Not sure

2.4 - No information about blinding and concealment was provided

- No information about dropout rate mentioned

- No actual value of 3 months post wound repair VAS score provided

56

S I G N


Man, S.Y., Wong, E.M.L., Ng, Y.C., et al. (2009). Cost-Consequence Analysis Comparing 2-Octyl Cyanoacrylate Tissue Adhesive and Suture for Closure of Simple Lacerations: A Randomized Controlled Trial. Annals of Emergency Medicine, 53(2), 189-197.




focused question.

Yes

Can’t say

No


is randomised.

Yes

Can’t say

No


Yes

Can’t say

No



Yes

Can’t say

No


start of the trial.

Yes

Can’t say

No



Yes

Can’t say

No



Yes

Can’t say

No

57




Tissue adhesive group

= 1%

Suture group = no

dropped out


Yes

Can’t say

No

Does not

apply



Yes

Can’t say

No

Does not

apply



High quality (++)

Acceptable (+)



Yes




Yes

2.4 - The cost of using 2-Octyl Cyanoacrylate tissue adhesive is more expensive

then traditional suture. However, 2-Octyl Cyanoacrylate tissue adhesive can

bring the follow benefits: 1. Reduce pain 2. Reduce procedure time

- Good at minimizing dropout rate (only 1 % in tissue adhesive group)

58

S I G N


Mattick, A., Clegg, G., Beattie, T., et al. (2002). Randomised, Controlled Trial Comparing a Tissue Adhesive (2-octylcyanoacrylate) with Adhesive Strips (Steristrips) for Paediatric Laceration Repair. Emergency Medicine Journal, 19(5), 405-407.




focused question.

Yes

Can’t say

No


is randomised.

Yes

Can’t say

No


Yes

Can’t say

No



Yes

Can’t say

No


start of the trial.

Yes

Can’t say

No



Yes

Can’t say

No



Yes

Can’t say

No

59





= 37%

Adhesive strip group =

17%


Yes

Can’t say

No

Does not

apply



Yes

Can’t say

No

Does not

apply



High quality (++)

Acceptable (+)



Yes




Yes

2.4 - Relatively high dropout rate (37%) in tissue adhesive group

- Study was only carried out in 1 hospital

- Subject population is small compared to other studies

60

S I G N


Osmond, M.H., Quinn, J.V., Sutcliffe, T., et al. (1999). A Randomized, Clinical Trial Comparing Butylcyanoacrylate with Octylcyanoacrylate in the Management of Selected Pediatric Facial Laceration. Academic Emergency Medicine, 6(8), 171-177.




focused question.

Yes

Can’t say

No


is randomised.

Yes

Can’t say

No


Yes

Can’t say

No



Yes

Can’t say

No


start of the trial.

Yes

Can’t say

No



Yes

Can’t say

No



Yes

Can’t say

No

61




Butylcyanoacrylate

group = 17%

Octylcyanoacrylate

group = 6%


Yes

Can’t say

No

Does not

apply



Yes

Can’t say

No

Does not

apply



High quality (++)

Acceptable (+)



Yes




Yes

2.4 - In the closure of small linear pediatric facial lacerations, octylcyanoacrylate is

similar to butylcyanoacrylate in ease of use and early and late cosmetic

outcomes

- Study was only carried out in 1 site

62

S I G N


Quinn, J., Wells, G., Sutcliffe, T., et al. (1998). Tissue Adhesive Versus Suture Wound Repair at 1 Year: Randomized Clinical Trial Correlating Early, 3-Month, and 1-Year Cosmetic Outcome. Annals of Emergency Medicine, 32(6), 645-649.




focused question.

Yes

Can’t say

No


is randomised.

Yes

Can’t say

No

1.3 An adequate concealment method is used. Yes

Can’t say

No



Yes

Can’t say

No


start of the trial.

Yes

Can’t say

No



Yes

Can’t say

No



Yes

Can’t say

No

63




3 months follow up:


= 26%

Suture group = 19%

1 year follow up:


= 45%

Suture group = 41%


Yes

Can’t say

No

Does not

apply



Yes

Can’t say

No

Does not

apply



High quality (++)

Acceptable (+)



Yes




Yes

2.4 - The assessment of wound 3 months post injury and wound repair provides a

good measure of long term cosmetic outcomes

- No concealment method mentioned

- Dropout rate is high in 1 year follow up

64

S I G N


Singer, A.J., Hollander, J.E., Valentine, S.M. et al., (1998). Prospective, Randomized, Controlled Trial of Tissue Adhesive (2-Octylcyanoacrylate) vs Standard Wound Closure Technique for Laceration Repair. Academic Emergency Medicine, 5(2), 94-99.




focused question.

Yes

Can’t say

No


is randomised.

Yes

Can’t say

No


Yes

Can’t say

No



Yes

Can’t say

No


start of the trial.

Yes

Can’t say

No



Yes

Can’t say

No



Yes

Can’t say

No

65




Octylcyanoacrylate

group = 3%

Standard suture group

= 10%


Yes

Can’t say

No

Does not

apply



Yes

Can’t say

No

Does not

apply



High quality (++)

Acceptable (+)



Yes




Yes

2.4 - Wounds treated with octylcyanoacrylate and standard wound closure

techniques have similar cosmetic appearances 3 months later

- Can provide more information about concealment method

- Study was limited in 1 site

66

S I G N


Singer, A.J., Quinn, J.V., Clark, R.E. & Hollander, J.E. (2002). Closure of Lacerations and Incisions with Octylcyanoacrylate: a Multicenter Randomized Controlled Trial. Surgery, 131(3), 270-276.




focused question.

Yes

Can’t say

No


is randomised.

Yes

Can’t say

No


Yes

Can’t say

No



Yes

Can’t say

No


start of the trial.

Yes

Can’t say

No



Yes

Can’t say

No



Yes

Can’t say

No




Octylcyanoacrylate

group = 3.5%

Suture group = 7.8%

67


Yes

Can’t say

No

Does not

apply



Yes

Can’t say

No

Does not

apply



High quality (++)

Acceptable (+)



Yes




Yes

2.4 - 2-Octyl Cyanoacrylate tissue adhesive has a low rate of dehiscence, low

infection rate, and provides excellent cosmetic results for closure of both

traumatic lacerations and surgical incisions.

- Follow up period is limited to 3 months, which cannot conclude that tissue

adhesive provides better cosmetic effect than traditional suture

68

S I G N


Zempsky, W.T., Parrotti, D., Grem, C., et al. (2004). Randomized Controlled Comparison of Cosmetic Outcomes of Simple Facial Lacerations Closed With SteriStrip, Skin Closures or Dermabond Tissue Adhesive. Pediatric Emergency Care, 20(8), 519-524.




focused question.

Yes

Can’t say

No


is randomised.

Yes

Can’t say

No


Yes

Can’t say

No



Yes

Can’t say

No


start of the trial.

Yes

Can’t say

No



Yes

Can’t say

No



Yes

Can’t say

No





= 8%

Steristrip group = 15%

69


Yes

Can’t say

No

Does not

apply



Yes

Can’t say

No

Does not

apply



High quality (++)

Acceptable (+)



Yes




Yes

2.4 - Steristrip skin closures and tissue adhesive provides similar cosmetic

outcomes for closure of simple facial lacerations.

- Study was only limited to 2 months

- Study was carried out in 1 site only

70

Appendix 4: Cost to the Hospital Authority in wound closure (per person)

Unit cost (in Hong Kong Dollars)

Variable Tissue adhesive Suture

Tissue adhesive (Dermabond) 140.0 N/A

5/O monofilament suture x 2 packs N/A 8.3

Normal saline solution for

wound dressing (1L)

5.2 5.2

Local anesthesia (LA) for suture

(1% lignocaine 5ml)

N/A 2.4

5ml syringe for LA infiltration N/A 0.4

Sterile suture set 3.0 3.0

Simple dressing set 2.7 2.7

Gauze x 2 packs 0.4 0.4

Sterile gloves 1.7 1.7

Total 153.0 24.1

Appendix 5: Cost to Hospital Authority in subsequent wound care in AED /

GOPD (per person)


Cost for equipment and materials in stitches removal

Variable Tissue adhesive Suture


wound dressing (1L)

N/A 5.2

Simple dressing set N/A 2.7

Gauze x 2 packs N/A 0.4

Sterile gloves N/A 1.7

Subtotal 0 10.0

Cost for equipments and materials in wound dressing


wound dressing (1L)

N/A 5.2

Simple dressing set N/A 2.7

Gauze x 2 packs N/A 0.4

Sterile gloves N/A 1.7

Subtotal 0 10.0

Total 0 20.0

71

Appendix 6: Total cost to the Hospital Authority in wound closure and

subsequent wound care (per person)


Tissue adhesive Suture

Cost for wound closure 153.0 24.1

Cost for subsequent wound care 0 20

Total 153.0 44.1

Appendix 7: Wound Care Charges for patient (per person)


Tissue adhesive Suture

Cost for wound closure in AED 100.0 100.0

Cost for suture removal at OPD 0 17.0

Cost for wound dressing at OPD 0 17.0

Cost for wound reassessment at OPD 0 45.0

Total 100.0 179.0

72

Appendix 8: Evidence-based Guideline for the Use of Tissue Adhesive in

Pediatric Patients with Facial Laceration in Accident and Emergency

Department

Background

Traumatic wounds are one of the most common reasons for people seeking

emergency medical care (Holger, et al., 2004)

Cyanoacrylate tissue adhesive provides a “needleless” alternative to conventional

sutures (Holger, et al., 2004; Man, et al., 2009; Mattick, et al., 2002; Osmond, et

al., 1999; Quinn, et al., 1998; Singer, et al., 2002; Singer, et al., 1998; Zempsky,

et al., 2004)

Current practice of wound closure (traditional skin suture) may inflict additional

pain to patients (Singer, et al., 2008) and is relatively time consuming (Mattick,

et al., 2002; Osmond, et al., 1999)

No clinical protocol is available for the use of tissue adhesive in the accident and

emergency departments.

Target Population

Pediatric patients (under age 18) with facial laceration

73

Target Settings

An accident and emergency department in Hong Kong

Aim

To assist medical professionals in using tissue adhesive for pediatric patients

who require wound closure in accident and emergency department

Objectives

To summarize and synthesize the current evidence for the use of tissue adhesives

in wound closure

To formulate recommendations for innovation based on the best available

evidence

74

Guideline Development

SIGN 50: A Guideline Developer's Handbook (Scottish Intercollegiate Guideline

Network (SIGN), 2011) as reference

Research Question: How effective are tissue adhesives (in terms of pain

associated with procedure, ease of procedure, time to complete the procedure,

cosmetic effect and cost required for treatment) for patients with traumatic

lacerations?

Literature Review

Searching Strategies

Databases

i. PubMed

ii. Sciencedirect

iii. Proquest

75

Keywords

Tissue adhesive* OR Emergency department* OR Laceration

Type of study: Randomized Controlled Trial (RCT)

Inclusion criteria

i. The patients recruited have acute, linear, low tension and traumatic laceration

wound

ii. It was conducted in the emergency settings

iii. It was a randomized controlled trial

Exclusion criteria

i. It was dealing with wounds such as surgical repairs, ulcers, skin grafts, dental

repairs and wounds involving mucocutaneous junctions

76

Appraisal Strategies

Level of Evidence (SIGN, 2013)

Table 1. Level of Evidence

1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a

very low risk of

bias

1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk

of bias

1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias

2++ High quality systematic reviews of case control or cohort or studies

High quality case control or cohort studies with a very low risk of

confounding or bias

and a high probability that the relationship is causal

2+ Well-conducted case control or cohort studies with a low risk of

confounding or bias and

a moderate probability that the relationship is causal

2- Case control or cohort studies with a high risk of confounding or bias and a

significant

risk that the relationship is not causal

3 Non-analytic studies, e.g. case reports, case series

4 Expert opinion

3

Search Results

10 RCTs

Implementation Potential Assessment

Transferability

Feasibility

Cost-benefit Ratio

77

Recommendations

Recommendation is graded by SIGN 50: A guideline developer’s handbook.

(SIGN, 2011)

Table 2. Grades of Recommendations

A

At least one meta-analysis, systematic review, or RCT rated as 1++, and

directly

applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly

applicable

to the target population, and demonstrating overall consistency of results

B

A body of evidence including studies rated as 2++, directly applicable to the

target

population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

C

A body of evidence including studies rated as 2+, directly applicable to the

target

population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

D Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

Good

practice

point

Recommended best practice based on the clinical experience of the

guideline

development group

Recommendation 1

Tissue adhesive can be used by doctors and nurses in performing wound closure

to patients. (Grades of Recommendation: A)

Tissue adhesive only requires simple introduction to medical professionals who

have skin suturing experience prior the use of it (Mattick, et al., 2002; Osmond,

et al., 1999) (1+, 1++)

78

Recommendation 2

Tissue adhesive can be used as alternative to traditional suture in lacerations that

required smaller sutures (~ 5/O monofilament suture).

(Grade of Recommendation: A)

Tissue adhesive can be used for laceration wound length ranged from 1cm to 3cm

(Man et al., 2009; Holger, et al., 2004; Mattick, et al., 2002; Osmond,et al., 1999;

Quinn, et al., 1998; Singer, et al., 1998; Singer, et al., 2002; Zempsky, et al.,

2004) (1++, 1+, 1+, 1++, 1+, 1+, 1++, 1++)

Recommendation 3

Patients’ wound condition should be assessed prior the use of tissue adhesive.

(Grades of Recommendation: A)

Tissue adhesive is contraindicated to patients with infected wound, wounds

across mucocutaneous junctions such as lips and oral cavity, or skin that is

regularly exposed to dense hair (e.g. scalp) (Osmond, et al., 1999; Singer, et al.,

1998; Singer, et al., 2002) (1++, 1+, 1++)

79

Recommendation 4

Tissue adhesive is preferred to be used in facial lacerations. (Grades of

Recommendation: A)

Facial laceration is the most common type of pediatric injury that requires wound

closure (Osmond, et al., 1999; Zempsky, et al., 2004) (1++, 1++)

Recommendation 5

Tissue adhesive should be considered after balancing the benefits (reduce

procedure time and pain) and risks (material cost and side-effects). (Grades of

Recommendation: A)

Patients with known hypersensitivity to cyanoacrylate or formaldehyde, high

tension wounds should be considered as contraindication for tissue adhesive

(Holger, et al., 2004; Man, et al., 2009; Zempsky, et al., 2004) (1+, 1++, 1++)

80

Appendix 9: Pediatric Wound Closure Record

Pediatric Wound Closure Record Form

Length of laceration: cm

Time for procedure: minutes

Pain score: /10

KWC Pain Assessment Tool

Please return the form to collection box upon completion

Patient Gum Label

81

Appendix 10: Satisfaction Survey to Healthcare Providers – The Use of Tissue Adhesive in Pediatric Patients with Facial

Lacerations

Please return the completed form to nurses’ station upon completion

Strongly

Disagree

Disagree Neutral Agree Strongly

Agree

I think this innovation can reduce laceration wound closure pain 1 2 3 4 5

I believe this innovation do not place any burden to frontline staff 1 2 3 4 5

I feel competent in using tissue adhesive in wound closure 1 2 3 4 5

I feel comfortable in using tissue adhesive in wound closure 1 2 3 4 5

I support the use of tissue adhesive in wound closure 1 2 3 4 5

Other opinions:

82

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