In Control Cambridge Ltd - Crawford Healthcare · 2016. 12. 15. · RM S S N N N AK1 S N N N N AK2 S S N N N AS S S N N N DM S S N N N EE S S N N N ES S S S N N GM1 M S S S S GM2

In Control Cambridge Ltd

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A Study to evaluate antibacterial dressing, KerraContact Ag, in the

management of venous leg ulcers

Aim

The main aim of this study was to evaluate the ability of KerraContact Ag dressing to

reduce the clinical signs of infection in venous leg ulcers. Also recorded were

wound area changes over time which is an indicator of healing rate. The ease of use

of the dressing was also noted.

Introduction

Venous leg ulcer prevalence rates fall into the range 1.2 – 3.2 per 1000 people (1).

This means that at any one time in the UK there are 70,000 – 190,000 individuals

with a venous leg ulcer. Most venous leg ulcers will heal within 2 to 3 months if

treated by trained healthcare professionals using the correct compression therapy.

One of the main factors affecting the repair process is the presence of infection.

These chronic wounds provide the perfect medium for bacterial growth. The two

main treatments for wound infections are antibiotics which are systemic and also

topical treatments for the wound surface. In addition to this various secondary

dressings/bandages are needed to absorb the excess exudate. All of these things

add to the cost of treatment of venous leg ulcers.

This study aims to demonstrate that the silver dressing KerraContact Ag (Crawford

Healthcare) has a role in reducing the signs and symptoms of infection in venous leg

ulcers.

Method

A clinical evaluation was undertaken on 15 patients, 7 male and 8 females. The

mean age was 73yrs and there was a total of 17 wounds within this group that were

monitored over a period of 4 weeks. All patients had adequate perfusion

demonstrated by an ABPI > 0.7 and were able to ambulate in their home

environment or clinic with or without mobility aids. All wounds included in this study

had a surface area of between 1 – 20cm2.


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Clinical diagnosis of infection or suspicion of infection was judged by the presence of at least 2 of the following criteria:

Increased exudation

Purulence

Odour

Pain caused by wound

Friable dull granulation tissue

Erythema >1-2cm from wound margin

Following informed consent, the wounds were assessed and photographed once per

week and all relevant data recorded. The wound was photographed together with

patient identifier and ruler to assess changes in wound dimensions over time.

KerraContact Ag was applied as per manufacturer’s instructions.

Data was collected assessing the following:

Wound size/area

Level and type of wound exudate

Level of odour

Type of pain and pain level on application, wearing and removal of dressing

Integrity of periwound skin

Appearance of dressing on removal

Wear time of dressing

Results

The clinical staff involved in this study were impressed with the dressing KerraContact Ag and felt it was very effective in dealing with the wound infections. They did, however, make a comment about the rigid nature of the dressing which they said made it more difficult to apply than other dressings they had used. They said that they found it easier to apply if they screwed the dressing up in their hand a few times prior to applying it to the wound. This appeared to soften the dressing up and allow it to mould to the wound surface more effectively. Apart from that one point they were very satisfied with the dressing.


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Results

Treatment for previous 12 weeks

Table 1 shows the treatment the wounds were receiving prior to starting this study.

Table 1.


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Wound Size

The data in table 2 shows the mean wound area as a percentage of initial wound

area at time 0. This data is expressed graphically in figure 1.

Table 2. Wound area assessment

Mean % +/-SEM

Time 0 100 0

1 week 87.05 3.63

2 weeks 77.05 5.53

3 weeks 62.76 7.21

4 weeks 48.4 8.14

Figure 1. Graph showing change in wound area over time

The data shows that the wounds decreased in size over the 4 week treatment period

to a mean of 48.4% of the initial wound area which indicates that the wounds are

healing.


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Level and Type of Wound Exudate

The data in Table 3 shows the exudate level and also the type of exudate at each

weekly assessment.

Table 3.

Exudate Level / Exudate Type

Patient Time 0 1 week 2 week 3 week 4 week

FF M / P M / P M / P L / S L / S

HP M / HM M / HM L / S L / S L / S

JM M / P H / P M / P L / S L / S

JM2 M / P M / P M / S L / S L / S

KS M / P M / P L / S L / S L / S

MH M / P M / P M / S M / S L / S

RM M / P M / P L / S L / S L / S

AK1 M / P M / S M / S M / S M / S

AK2 M / P M / S M / S M / S M / S

AS H / P H / P M / S M / S M / S

DM L / P L / P L / HM L / HM L / S

EE M / P M / P M / P M / S L / S

ES H / P M / P M / P M / S M/ S

GM1 H / P H / P M / P M / P M / P

GM2 H / P M / P M / P M / P M / P

PR H / P H / P H / P H / P H / P

SD M / P M / P M / P M / S M / S

Key:

Exudate Level is also expressed in pie chart format in figure 2.

Exudate Level L = Low

M = Moderate

H = High

Exudate Type S = Serous

HM = Haemoserous

P = Purulent


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Figure 2a. Pie Chart showing the exudate level at time 0

Figure 2b. Pie Chart showing the exudate level after 4 weeks

The data shows that there has been a large change in exudate levels over the 4

week treatment period. At time 0 only 6% of the wounds were classed as low

exudating whereas the remaining 94% were classed as moderate to high exudating.

After 4 weeks of treatment only 6% of wounds were classed as high exudating

whereas 53% of the wounds were classed as low exudating.


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Figure 3 below shows the change in exudate type between time 0 and 4 weeks.

Figure 3a Exudate type at time 0

Figure 3b Exudate type after 4 weeks

The data shows that there is a large movement away from purulent exudate which

dominated the wounds at time 0 to serous exudate which dominates the wounds

after 4 weeks. This indicates that the infected wound percentage has demonstrated

a large decrease.


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Level of Odour

The data in Table 4 shows the level of odour detected at the assessment time point

dressing change.

Table 4.

Odour


FF S S N N N

HP N N N N N

JM S S S N N

JM2 S S N N N

KS S S N N N

MH S N N N N

RM S S N N N

AK1 S N N N N

AK2 S S N N N

AS S S N N N

DM S S N N N

EE S S N N N

ES S S S N N

GM1 M S S S S

GM2 M S S S S

PR M S S S S

SD S N N N N

Key:

Odour Level is also expressed in pie chart format in figure 4.

Odour N = None

S = Some

M = Significantly Malodorous


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Figure 4a. Pie Chart showing the odour level at time 0

Figure 4b. Pie Chart showing the exudate level after 4 weeks

Figure 4 shows that odour levels have dramatically reduced over the 4 week

treatment period. At time 0 94% of the wounds were odorous, 18% significantly so.

After 4 weeks treatment 82% of wounds were assessed as being not odorous and

the remaining 18% were odorous but none significantly so. This indicates a

reduction in infection.


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Pain

Table 5a shows the type of pain that was present throughout the treatment period.

Table 5a

Pain


FF 4 6 None None None

HP 2 + 5 2 + 5 3 + 5 None None

JM 1 + 2 2 1 + 5 1 + 5 1 + 5

JM2 None None None None None

KS 2 + 6 2 + 6 2 + 5 2 + 5 2 + 5

MH None None None None None

RM None None None None None

AK1 1 1 1 None None

AK2 1 1 1 None None

AS 1 + 2 5 1 + 5 1 + 5 5

DM 1 1 None None None

EE 5 5 5 5 None

ES 3 + 5 None None None None

GM1 1 + 2 + 4 1 + 2 + 6 1 + 2 + 6 1 + 2 + 6 1 + 2 + 6

GM2 1 + 2 + 4 1 + 2 + 6 1 + 2 + 6 1 + 2 + 6 1

PR 1 + 4 1 + 5 3 + 5 3 + 5 3 + 5

SD 3 + 5 3 + 5 3 + 5 3 + 5 3 + 5

Key:

Pain Type 1 = Burning

2 = Stabbing

3 = Aching

4 = Continuous

5 = Intermittent

6 = Itching


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Table 5b shows the pain level of that was experienced by each patient at 3 time

periods:

1 - Application of the dressing

2 - Wearing of the dressing

3 - Removal of the dressing.

Pain level was judged on a scale 1-10 with 1 being no pain and 10 being worst pain.

Table 5b.

Pain

Patient week 1 week 2 week 3 week 4

FF 1+4+1 1+1+1 1+2+1 1+2+1

HP 1+3+1 1+2+1 1+1+1 1+1+1

JM 1+1+1 1+5+1 1+5+1 1+3+1

JM2 1+1+1 1+5+1 1+1+1 1+1+1

KS 1+6+1 1+2+1 1+3+1 1+3+1

MH 1+1+1 1+1+1 1+1+1 1+1+1

RM 1+1+1 1+1+1 1+1+1 1+1+1

AK1 1+4+4 4+4+4 1+1+1 1+1+1

AK2 3+3+5 2+2+2 1+1+1 1+1+1

AS 4+4+4 2+4+5 1+2+2 2+1+1

DM 2+2+2 1+1+1 1+1+1 1+1+1

EE 4+4+4 4+4+3 5+5+5 1+1+1

ES 1+1+1 1+1+1 1+1+1 1+1+1

GM1 7+7+7 7+7+7 7+7+7 7+7+7

GM2 7+7+7 7+7+7 6+6+6 5+5+5

PR 1+4+2 1+4+2 1+4+2 1+2+1

SD 1+3+3 1+3+3 1+2+2 1+2+2

In the above table there are 3 numbers for each period:

First number = pain score on application of dressing

Second number = pain score on wearing the dressing

Third number = pain score on removal of the dressing

The data from table 5b is expressed graphically in figure 5.


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Figure 5. Bar Chart showing pain levels over 4 week treatment period.

Figure 5 shows that over the 4 week treatment period pain reduction was seen at

each of the 3 assessment points. Pain decrease is an indication that infection is

decreasing (2).


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Integrity of Periwound Skin

One of the clinical challenges of colonised or infected chronic wounds is protecting

the surrounding skin from the effects of moisture. The chronic wound will produce

increased amounts of wound fluid. If not absorbed or controlled by reducing the bio-

burden will lead to maceration and wound deterioration. Several parameters were

rated including maceration, oedema, and erythema at each assessment point. The

results are shown in table 6.

Table 6.

Periwound Skin


FF 6 6 4 4 4

HP 3 7 (callus) 1 1 1

JM 3 1 1 1 1

JM2 7(Eczema) 7(Eczema) 7(Eczema) 7(Eczema) 7(Eczema)

KS 7(Fragile) 7(Fragile) 1 1 1

MH 1 1 1 1 1

RM 1 1 1 1 1

AK1 6 6 1 1 1

AK2 5 1 1 1 1

AS 5 5 + 6 4 4 4

DM 1 1 1 1 1

EE 7(Eczema) 7(Eczema) 7(Eczema) 7(Eczema) 7(Eczema)

ES 7(Eczema) 7(Eczema) 7(Eczema) 7(Eczema) 7(Eczema)

GM1 4 + 6 4 + 6 1 1 1

GM2 5 + 6 4 1 3 1

PR 3 + 5 3 1 5 1

SD 5 1 1 1 1

Key:

Periwound skin condition 1 = Healthy

2 = Breaking down

3 = Macerated

4 = Erythema 1 – 2cm

5 = Erythema < 1 – 2cm

6 = Oedematous

7 = Other (Specify)


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The results from table 6 are shown in figure 6 which compares the periwound skin at

time 0 to that at the week 4 time point.

Figure 6a. Bar chart showing the condition of the periwound skin at time 0

Figure 6b. Bar chart showing the condition of the periwound skin after 4 weeks

The results demonstrate an improvement in the periwound skin of the patients with

most showing a healthy profile.


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Appearance of Dressing on Removal

The appearance of the dressing on removal was rated by the clinician. The rating

was based on judging the dressing on the following 4 factors:

Was the dressing - as applied, partially adhered, not insitu, desiccated

The results are shown in table 7.

Table 7

Appearance of Product

Patient 1 week 2 week 3 week 4 week

FF 1 1 1 2

HP 1 1 1 1

JM 2 1 1 1

JM2 1 1 1 1

KS 1 2 1 1

MH 1 1 1 1

RM 1 1 1 1

AK1 1 1 1 1

AK2 1 1 1 1

AS 1 1 2 1

DM 1 1 1 1

EE 1 1 1 1

ES 1 1 1 1

GM1 1 1 1 1

GM2 1 1 1 1

PR 1 1 2 2

SD 2 1 1 2

Key:

The above data is expressed graphically in figure 7 in the following way. There are

17 wounds and each wound has been assessed 4 times after the initial time zero

assessment. This means that we have 68 individual time points to assess the

appearance of the dressing at. This is shown in figure 7.

Appearance of Dressing 1 = As applied

2 = Partially adhered

3 = Dressing not insitu

4 = Dressing Desiccated


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Figure 7.

The data shows that the dressing performed well in that it was mostly as applied

when inspected or partially adhered to the wound as shown as demonstrated in a

few of the cases.


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Wear Time of Dressing

The dressing wear time in days was assessed and the results are shown in table 8.

Table 8

Patient 1 week 2 week 3 week 4 week

FF 7 3 5 4

HP 3 7 7 7

JM 2 3 3 3

JM2 4 7 4 4

KS 3 3 3 4

MH 4 3 3 7

RM 3 7 7 7

AK1 4 4 4 4

AK2 4 4 4 4

AS 4 4 2 2

DM 7 7 4 6

EE 3 7 3 7

ES 3 4 7 7

GM1 7 7 4 4

GM2 7 7 4 4

PR 7 7 4 7

SD 5 7 7 7

The results are expressed graphically in figure 8. There are 17 wounds and each

wound has been assessed 4 times after the initial time zero assessment. This

means that we have 68 individual time points to assess the wear time of the

dressing.

Figure 8.

The majority of dressings in this study were changed at 3, 4 and 7 days.


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pH Values

The pH level of a wound can be a clinical indication to healing. During this study simple litmus paper was applied to the wound fluid at dressing changes. A pH of 7 represents neutral; a pH below 7 is acidic representing a higher hydrogen concentration, while a pH value above 7 is termed base or alkaline and represents a lower hydrogen concentration. The pH values were assessed at each time point and are shown in table 9. Table 9. pH values at each assessment point


FF 8 8 8 8 8

HP 8 8 8 8 8

JM 8 8 8 8 8

JM2 8 8 7 8 8

KS 8 8 7 8 7

MH 8 8 8 8 8

RM 8 8 8 8 8

AK1 8 8 8 8 8

AK2 8 8 8 8 8

AS 8 8 8 8 7

DM 7 7 7 8 8

EE 8 8 8 8 7

ES 8 8 8 8 8

GM1 8 8 8 8 8

GM2 8 8 8 8 8

PR 8 8 8 8 8

SD 8 8 8 8 7

The results show that there was not too much change in pH value with most being

just above neutral.


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Wound Healing Continuum

The wound healing continuum is a recognised tool as a way of identifying the colours present in any given wound (3) and applying the most significant colour to the spectrum e.g. black defining necrosis through to pink healthy epithelisation. The results are shown in table 10. Table 10.


FF 4 4 4 4 4+6

HP 4 4 4 4 4

JM 5 3 + 6 3 + 6 6 6

JM2 4 4 4 4 6

KS 3 4 4 3 + 6 3 + 6

MH 4 4 4 6 7

RM 3 3 4 7 Closed

AK1 3 3 4 4 6

AK2 4 5 5 5 6

AS 3 3 3 + 6 3 + 6 3 + 6

DM 5 4 6 6 6

EE 3 4 3 + 6 3 + 6 3 + 6

ES 5 5 5 6 7

GM1 2+5 2+5 5 5 2+5

GM2 5 4 5 5 2 + 6

PR 4 4 4 3 + 6 6

SD 6 6 6 6 6

Key: The results are expressed graphically in figure 9.

Wound continuum 1 = Black

2 = Black / yellow

3 = Yellow

4 = Yellow / red

5 = Red

6 = Red / pink

7 = Pink


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Figure 9a

Figure 9b

The results show that at the start of the study most wounds were around the yellow to red zone, whereas at the end of the study the graph shows a movement to the right which puts the majority of the wounds in the Red/Pink zone. This indicates that the majority of the wounds were progressing towards healing throughout this study.


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Samples of Patient Photographs Demonstrating Effectiveness of KerraContact Ag

The following section shows some samples of wound photographs taken during this study. Example 1 – RM

Time 0 1 week

2 week 3 week

4 week


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Example 2 – RM

Time 0 1 week

2 week 3 week

4 week


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Example 3 – PR

Time 0 1 week

2 week 3 week

4 week


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Example 4 – HP

Time 0 1 week

2 week 3 week

4 week


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Conclusion

This study has produced positive results demonstrating that KerraContact Ag both stimulates healing, as shown in the wound area data, and also reduces the signs of infection, as demonstrated in the other assessments.

The management of chronic wounds represents a significant burden, not only in terms of direct costs to healthcare services (4) but in terms of patient safety and quality of life. The management becomes an even greater problem when bacteria are present in wounds as this can have a negative impact on healing. At the same time there is concern over the increase of multi-resistant bacteria in wound care (5). Silver has been used for medicinal purposes for thousands of years and is once again gaining popularity due, in part, to the rise of these multi-resistant strains (6).

The objective in managing infected venous ulcers is to reduce the signs and symptoms of infection allowing compression to treat the underlying cause. The results of this study indicate that KerraContact is having this effect.

References

1. Graham ID, Harrison MB, Nelson EA, Lorimer K, Fisher A. (2003). Prevalence of a lower-limb ulceration: a systematic review of prevalence studies. Adv. Skin Wound Care 16(6): 305-316.

2. Cutting KF (2008) Should evidence dictate clinical practice, or support it? J

Wound Care 17(5): 216

3. White RJ (2002) The wound infection continuum. Br.J Nurs 11(22 Suppl): 7–9

4. Vanscheidt W., Lazareth I, Routkovsky-Norval C. (2003) Safety Evaluation of a new ionic silver dressing in the management of chronic ulcers. Wounds 15(11):371-378

5. Graham C. (2005). The role of silver in wound healing. BJN 14(19):S22, S24, S26

6. Driver VR (2004). Silver dressings in clinical practice. Ostomy Wound Management. 50(9A): 11s-15s.

Documents

In Control Cambridge Ltd - Crawford Healthcare · 2016. 12. 15. · RM S S N N N AK1 S N N N N AK2 S S N N N AS S S N N N DM S S N N N EE S S N N N ES S S S N N GM1 M S S S S GM2