A randomized, controlled study comparing the cosmetic outcome of a new wound closure device with Prolene suture closing caesarean wounds

ORIGINAL ARTICLE

A randomized, controlledstudy comparingthe cosmetic outcomeof a new wound closuredevice with Prolene sutureclosing caesarean woundsSven Juergens, Carolin Maune, Fatima Kezze, Thorsten Mohr,Katrin Scheuer, Peter Mallmann

Juergens S, Maune C, Kezze F, Mohr T, Scheuer K, Mallmann P. A randomized, controlled study comparing thecosmetic outcome of a new wound closure device with Prolene suture closing caesarean wounds. Int Wound J2011; 8:329–335

ABSTRACTA prospective, randomised study was conducted to compare the wound closure performance and cosmetic outcomeof caesarean section wounds closed with traditional Prolene suture or a new wound closure device (Leukosan®SkinLink). Sixty-one patients referred to primary section were allocated to wound closure with either Leukosan®SkinLink or Prolene suture. Cosmetic outcome as the primary measure was evaluated by the patient, the surgeon aswell as by independent examiners blinded to the method of wound closure. Evaluations were recorded at 3, 6 and12 months following wound closure. Both methods of wound closure scored equally high on the visual analoguescale for cosmetic evaluation at the 3-, 6- and 12-month follow-ups as assessed by the patient, surgeon and theblinded observers. The study has shown that innovative methods for wound closure compared with traditionalmethods such as suture providing excellent cosmetic results represent a valid alternative to physician and patientfor surgical incisions.

Key words: Caesarean section • Cosmetic outcome • Leukosan® SkinLink • Suture • Wound closure

Authors: S Juergens, MD, Department of Gynaecology and Obstetrics, University of Cologne, 50924 Cologne, Germany, TagesklinikAltonaer Strasse, Altonaer Straße 57, 20357 Hamburg, Germany; C Maune, PhD, BSN medical GmbH, Quickbornstrasse 24, 20253Hamburg, Germany; F Kezze, Department of Gynaecology and Obstetrics, University of Cologne, 50924 Cologne, Germany; T Mohr, MD,Asklepios Klinik Altona, Department of Gynaecology and Obstetrics, Paul-Ehrlich-Straße 1, 22763 Hamburg, Germany; K Scheuer, MD,Asklepios Klinik Altona, Department of Gynaecology and Obstetrics, Paul-Ehrlich-Straße 1, 22763 Hamburg, Germany; P Mallmann, MD,Department of Gynaecology and Obstetrics, University of Cologne, 50924 Cologne, Germany

Address for correspondence: Dr Sven Juergens, Tagesklinik Altonaer Strasse, Altonaer Straße 57, 20357 Hamburg, GermanyE-mail: [email protected]

© 2011 The Authors© 2011 Blackwell Publishing Ltd and Medicalhelplines.com Inc • International Wound Journal • Vol 8 No 4 329

New wound closure device SkinLink

INTRODUCTIONSuturing has been the standard form of woundclosure for over 4000 years. Although woundclosure with sutures is effective and safe, it

Key Points

• wound closure devices such assutures, staples, adhesive stripsand tissue adhesives are regu-larly used for wound closure

• wound closure in the operatingroom is more challenging thanin the emergency room and thereliability of new wound closureproducts has to be proven

• aim of this study was to com-pare a new wound closure de-vice (Leukosan® SkinLink) withstandard suture for its cosmeticoutcome after surgery

• caesarean sections were cho-sen as this is a common, yetchallenging surgery with noagreed standard on operativetechniques and materials to beused for wound closure

• as the cosmetic outcome is ofupmost importance for the fe-male patient, the study isfocussed on the evaluation ofthe cosmetic result after 3, 6and 12 months post surgery

• the results from our study showthat the new wound closuredevice was comparable to thestandard method of suturing inall aspects investigated

• the new wound closure devicerepresents a valid alternative totraditional suturing for closingcaesarean section woundsleaving patients and surgeonswith an additional non invasiveoption

bears certain disadvantages: it requires spe-cialised instruments and skilled operators, cre-ates additional trauma and requires removal.Lately, wound closure devices such as staples,adhesive strips and tissue adhesives have alsoproved feasible and safe for skin closure. Noninvasive wound closure devices such as adhe-sive strips and tissue adhesives in particular areincreasingly used for repair of traumatic lac-erations in children and adults in emergencyrooms, offering reliable wound closure as wellas acceptable cosmetic results (1–4). In theoperating room, wound closure is often morechallenging and the use of the closure devicesenabling optimal wound repair is dependenton the preferences and experiences of the sur-geon. Although reliable wound closure andcosmetic outcome are the main focus, dura-tion of wound closure and costs are additionalfactors that are considered. Therefore, surgicaltapes, staples and tissue adhesives as alterna-tive methods have also entered the operatingroom (5–10).

In addition to the established wound closuredevices, innovative products are still enter-ing the market whose reliability still has tobe proved (11,12). Leukosan® SkinLink (BSNmedical GmbH, Hamburg, Germany), a com-mercially available wound closure device, rep-resents such an innovative system for woundclosure, combining the advantages of woundclosure strips and topical skin adhesives foradditional fixation. Leukosan® SkinLink con-sists of perforated, non woven textile stripscoated with pressure-sensitive adhesive anda surgical adhesive (N-butyl-2-cyanoacrylate)which additionally anchors the strips to theintact skin on either side of the wound. In addi-tion to repair of traumatic wounds, Leukosan®SkinLink is suitable for closing surgicallyinflicted wounds. As these types of woundsare most commonly closed using sutures, astudy was designed to compare wounds closedwith either Leukosan® SkinLink or Prolenesuture. Caesarean sections were chosen asthis is a common, yet challenging surgerywith no agreed standard on operative tech-niques and materials to be used (13–16). Theideal method of closing the skin following

a Pfannenstiel incision has not been estab-lished yet and any new technique providingan excellent cosmetic outcome is welcomed toprovide women and their consulting obstetri-cian with alternative choices. As the cosmeticresult is of upmost importance for the patient,the study is focussed on the evaluation of thecosmetics.

MATERIALS AND METHODSFollowing the institutional ethical boardapproval (Arztekammer Hamburg, Germany,Ref. no. 2754), between June 2007 and March2009, pregnant patients referred for primarysection were evaluated for study inclusion.Informed consent was obtained from allpatients who were included in this study.

PatientsExclusion criteria included the following:known allergy to cyanoacrylates, formalde-hyde or dressing strips and patients sufferingfrom impaired wound healing, dermatoses,keloid formation, adipositas, impaired bloodclotting or diabetes. Sixty-one pregnant womenwho were to undergo primary section wereincluded in this study. They were then ran-domly allocated for topical wound closure witheither Prolene suture or Leukosan® SkinLinkusing a computer-generated randomised num-ber system.

Before inclusion of the first patient, patientnumbers were allocated randomly to oneof the wound closure procedures by avalidated Statistical Analysis System (SAS)(program components) program using theSAS function ‘ranuni’. The allocation wasfixed electronically and as paper printout(random list). The random list was handedover to the investigator. Patients who wereincluded in the study were assigned the nextlower patient number. The wound closure wasperformed according to the procedure as givenby the random list for the respective patientnumber.

Surgical technique and wound closureFor peri-operative antibiotic prophylaxis, weused gramaxine. The skin preparation includedCutasept F® (BODE Chemie GmbH, Hamburg,Germany), Octenisept® (Schulke & MayrGmbH, Norderstedt, Germany) and shaving

© 2011 The Authors330 © 2011 Blackwell Publishing Ltd and Medicalhelplines.com Inc


of the pubic hair using a shaving machine.Normothermia was achieved by a forced-airconvection warming system.

The surgical technique entailed the place-ment of deep sutures in the subcutaneous fat.When placing deep sutures, absorbable Vicryl2-0 was used. The knot was buried. In addi-tion, a subcuticular (subdermal) suture wasplaced by inserting the needle at the junctionof the dermis and the subcutis. The needlecurved upwards and exited in the papillarydermis. Atraumatic skin-handling techniquewith instruments such as skin hooks and smallforceps was used. A cutting needle was theneedle of choice.

For topical closure with Prolene, the runningsubcuticular was placed by taking horizontalbites through the papillary dermis on alter-nating sides of the wound. No suture markswere visible. The suture was looped throughthe subcuticular tissue by successively pass-ing through the opposite sides of the wound.The knot was tied at the opposite end ofthe wound by knotting the long end of thesuture material to the loop of the last passthat was placed. Topical wound closure withLeukosan® SkinLink was performed accordingto the manual.

EvaluationFollowing surgery, wound closure perfor-mance as well as ease of application wereassessed by the treating physician using ascale ranging from 1 to 10 (1 at one end rep-resenting an unsatisfying closure or difficultapplication and 10 at the opposite end repre-senting very good closure or very easy appli-cation). Complications and unexpected eventswere documented by the treating physician.On the day of suture or Leukosan® SkinLinkremoval, the patient was asked to assess thewearing comfort and the pain on suture orLeukosan® SkinLink removal. In addition, thewounds were judged for cosmetic appearanceby the physician using an approved 100-mmvisual analogue scale (VAS) (17), which statedthat 0 at one end represented a ‘poor scar’and 100 at the opposite end represented a‘perfect scar’. Patients returned to have theirwounds photographed at 3, 6 and 12 monthsfollowing caesarean section. Photographs weretaken using a digital camera in a standardisedmanner as regards distance from the subject,

lighting and exposure. At each visit, the cos-metic appearance was evaluated by the patientas well as the physician using the 100-mmVAS.

The photographs of the scars taken at the3-, 6- and 12-months’ postoperative visits werethen also presented to three examiners blindedto the method of wound closure who inde-pendently evaluated the photographs usingthe VAS.

Generally, patients who underwent cae-sarean section remained under inpatientsurveillance for 7 days, covering the primarywound healing time; wound healing in thisperiod of time is duly recorded. Enquiriesabout other potential infections after thisperiod were made in the follow-up visits at 3,6 and 12 months. As definition for surgical siteinfection (SSI), the guidelines of the ‘NationalesReferenzzentrum fur Surveillance von nosoko-mialen Infektionen’ by Robert-Koch-Institutwere applied.

Statistical analysisNon parametric statistics were only usedfor the comparison of the cosmetic results.Descriptive statistics was carried out for thefollowing parameters indicated in Tables 1and 2: demographic data (age, weight andheight), wound closure performance, ease ofapplication, wearing comfort and pain onremoval. Statistical analysis comparing the twomethods of wound closure was carried out withWilcoxon test. Significance was ascribed to aP-value < 0·05.

RESULTSA total number of 61 women were initiallyentered into the trial and by random allocation,30 were treated with Prolene suture and 31 withLeukosan® SkinLink. Both groups were demo-graphically similar (Table 1). Twelve patientswere lost to follow-ups throughout the timebecause of lack of contact. Of the 49 patientswho completed the study, 23 were in theProlene suture and 26 in the Leukosan® Skin-Link arm. All patients in the study had theircaesarean section performed by experiencedgynaecologists. Application of Leukosan®SkinLink was performed as described in theuser’s manual.

On the day of surgery, assessment of woundclosure performance by the surgeons resulted

© 2011 The Authors© 2011 Blackwell Publishing Ltd and Medicalhelplines.com Inc 331


Table 1 Demografic patient data

Patient data Treatment Mean SD Median Minimum Maximum n

Age (years) Prolene suture 32·1 4·7 33·0 24·0 42·0 30Leukosan® SkinLink 32·2 5·2 33·0 18·0 39·0 31

Weight (kg) Prolene suture 71·7 11·4 71·5 50·0 93·0 30Leukosan® SkinLink 70·5 8·9 70·0 52·0 88·0 31

Height (cm) Prolene suture 171·1 4·1 171·0 163·0 178·0 30Leukosan® SkinLink 171·9 5·1 170·0 164·0 181·0 31

Table 2 Wound closure performance and ease of application as assessed by the surgeon at the day of surgery

Method Mean SD Median Minimum Maximum n

Wound closure performance Prolene suture 9·0 0·9 9·0 7·0 10·0 30Leukosan® SkinLink 8·9 1·3 9·0 5·0 10·0 31

Ease of application Prolene suture 9·2 0·7 9·0 8·0 10·0 30Leukosan® SkinLink 8·7 1·3 9·0 5·0 10·0 31

0

1

2

3

4

5

6

7

8

9

10very good

not satisfyingProlene suture Leukosan® SkinLink

8.6 ± 0.36 8.3 ± 0.35

Wearing comfort - patient's assessment

®

8·6 ± 0·36 8·3 ± 0·35

Figure 1. Wearing comfort as assessed by the patients beforedischarge from the hospital.

in comparably high values (8·96 ± 0·9 versus8·90 ± 1·3). As regards ease of application,Prolene suture as the standard method ofwound closure scored slightly higher (9·18 ±0·7 versus 8·70 ± 1·3) (Table 2).

Wearing comfort as evaluated by the patientsshowed comparably high values of satisfactionfor both closure techniques (8·6 ± 0·4 Prolenesuture versus 8·3 ± 0·4 Leukosan® SkinLink)(Figure 1). Pain experienced on removingeither sutures or Leukosan® SkinLink was alsoevaluated by the patients, showing low painscoring for both methods (2·82 ± 0·5 versus3·08 ± 0·4) (Figure 2).

As regards complications, no differencewas found between Leukosan® SkinLink andProlene closure. One single case of dehis-cence was reported for Leukosan® Skin-Link. No allergic reaction or infection wasreported.

Pain on removal - patient's assessment

0

1

2

3

4

5

6

7

8

9

10unbearable

pain

no pain

2.82 ± 0.53 3.08 ± 0.36

Prolene suture Leukosan® SkinLink

2·82 ± 0·53 3·08 ± 0·36

® SkinLink

Figure 2. Pain experienced by the patients on removing eitherLeukosan® SkinLink or Prolene.

The cosmetic appearance of the scar wasevaluated at 3, 6 and 12 months post surgery. Itwas evaluated by the physicians, the patients aswell as a group of three gynaecologists blindedto the method of wound closure. The blindedexaminers evaluated digital photographs takenduring the follow-up visits independently. Nosignificant difference between the two closuretechnique was found at any time point orfor any group assessing the cosmetic outcome(patient’s assessment at 3, 6 and 12 monthspost surgery: P = 0·08, P = 0·42 and P = 0·32;physician’s assessment: P = 0·71, P = 0·72 andP = 0·33; assessment blinded observers: P =0·64, P = 0·26 and P = 0·07; Figure 3A–C).Leukosan® SkinLink scored equally high asthe standard method (Figure 3A–C). The cos-metic appearance of the scars was compa-rable for both methods of wound closure(Figure 4A–D).



Cosmetic appearance - assessment by surgeon

0

10

20

30

40

50

60

70

80

90

100very good

not satisfying 3 6 12months

3 6 12months

A

91·3 91·1 87·7


92·2 92·1 87·6

3 6 12months

3 6 12months

®

Cosmetic appearance - assessment by patients

0

10

20

30

40

50

60

70

80

90

100very good

not satisfying3 6 12

months3 6 12

monthsProlene suture Leukosan® SkinLink

86·6 87·8 90·3 92·7 91·9 91·0

B

3 6 12months

3 6 12months

®

Cosmetic appearance - assessment by blinded examiners

0

10

20

30

40

50

60

70

80

90

100very good

not satisfying 3 6 12months

3 6 12months


82·6 86·2 90·0 82·3 82·3 85·1

C

3 6 12months

3 6 12months

®

Figure 3. Assessment of the cosmetic appearance of thewound closed with either Leukosan® SkinLink or Prolene.Evaluation of cosmetic results by the surgeon (A), patients (B)and blinded examiners (C) at 3, 6 and 12 months post surgery.

DISCUSSIONNon invasive wound closure devices suchas adhesive tapes and topical adhesives areideal for closure of simple, low-tension lacera-tions (1). Regarding the use of the non invasivewound closure devices for more challengingsurgically inflicted wounds such as higher ten-sion or longer wounds, data are limited. Formany surgeries, the ideal method of closingthe skin is not established and surgeons appearto choose a technique based on their individual

A Prolene suture after three months

B Prolene suture after twelve months

C Leukosan ® SkinLink suture after three months

D Leukosan® SkinLink suture after twelve months

Figure 4. Cosmetic results following a Pfannenstiel incisionclosed with Prolene suture (A + B) and the new wound closuredevice Leukosan® SkinLink (C + D) after 3 and 12 months.

experiences and preferences. New devices forwound closure entering the market may repre-sent effective alternatives to the traditional noninvasive wound closure devices.

This study aimed to investigate whetherone of these new wound closure devices,Leukosan® SkinLink, is a reliable alternativefor wound closure following surgery. As targetwounds, wounds following primary sectionwere chosen. While caesarean section is acommon procedure performed on womenworldwide, the ideal method of closingthe skin following a Pfannenstiel incisionremains controversial (13,16). A great varietyof materials and techniques are used for skinclosure and there is still a need to identify whichprovide the best outcomes for women (15,16).In addition, wounds following caesareansection are challenging as it is a surgery duringwhich several layers of the mother’s abdomenneed to be cut and need to be closed again.

The results of this study show thatLeukosan® SkinLink was comparable withthe invasive method of suturing in all aspectsinvestigated. Similar to suturing, which is atechnical skill, application of Leukosan® Skin-Link also requires some instruction and prac-tice. The surgeons in this study had proficiencyin both methods of wound closure and theirassessment showed high satisfaction with bothmethods regarding ease of application andwound closure performance.

In this study, infection was reported. Gen-erally, international published SSI rates varyfrom 2·9% to 17·9% for caesarean section,depending on body mass index (BMI), age,



blood loss, method of wound closure andemergency procedures (18) As patients withhigh risk criteria and emergency cases wereexcluded, the low incidence is within range (ofthe limited number of cases).

Wearing comfort and pain on removal areimportant to the patient. Invasive methodssuch as suturing and stapling are known to pro-duce anxiety because of the need for removaland stapling in particular has been reported tocause postoperative discomfort (9,13). In thisstudy, patient assessment showed no differ-ence between Prolene suture and Leukosan®SkinLink for pain on removal and wearingcomfort. Although higher pain scores could beexpected for Prolene suture, it is likely that theanxiety in relation to suture removal is exag-gerated at least in relation to adult patients. Inregard to wearing comfort, the study showedthat both methods of wound closure are validoptions. No allergic reaction or infection wasreported. In addition, Leukosan® SkinLink isa medical device for which testing has beenconducted in accordance with biocompatibil-ity tests (ISO 10993). Testing certifies thatLeukosan® SkinLink is not cytotoxic, not anirritant and not a sensitizer.

The benefits of Leukosan® SkinLink areatraumatic wound closure (no local anaesthesiarequired, no additional punctures to woundedges), no additional materials required (nosurgical instruments and no resterilisation),doctor can close wound without the help ofnurse/assistant and there is a quick learningcurve. No repeat visit of patient to removestitches is required and there is a high patientcomfort.

We put no attention to comparative costs asthey depend on the commercial politics of BSNmedical, (data on file at BSN medical). How-ever, it can be claimed that the benefits of thisatraumatic device find their financial expres-sion, for example, no cost for local anaesthesia,no resterilisation of additional instruments, noadditional nurse/assistant and no repeat visitof patient to remove stitches, which gain moreweight in ambulatory surgery.

In addition, the new method is time-savingfor medical team: compared with continuoussutures and separate stitches, SkinLink isshortening wound closure time. To test thetime efficiency of the device ‘SkinLink’, thedevelopers conducted tests on pig skin, data onfile at BSN medical. Incisions of 4–8 cm were

made on pig skin. These were then treatedin parallel, using separate stitches, continuoussutures and using SkinLink. The resultsindicate that using SkinLink is ∼45–65% fasterthan using sutures on identical wound sites.

Cosmetic acceptability of a scar is animportant outcome of wound repair for thepatient and surgeon and caesarean sectionin particular represents a surgery followingwhich the appearance of the scar is highlyimportant to women. Therefore, focus was laidto assess in detail the cosmetic outcome asachieved by the two closure methods. In thisstudy, the cosmetic appearance of the scar wasassessed by the surgeon, the patient as well asby three gynaecologists blinded to the methodof wound closure in order to minimise bias.For scar assessment, follow-up visits at 3, 6and 12 months post surgery was chosen asshorter follow-up periods are often discussedto limit study validity (2,16). At any follow-up,Leukosan® SkinLink provided equally highcosmetic results to suturing as assessed by thesurgeon, patient and blinded observers.

The study design incorporates the followinglimitations: the statistical power of the study islimited by sample size of 61 patients and there-fore has the character of a pilot study. However,as wounds inflicted by caesarean section rep-resent a quite homogenous and standardisedtype of wound and the women patients alsorepresent a rather homogenous study group(see demographic data) the outcome of thestudy is still valid despite small sample size.In addition, restrictions from using blindedexaminers include substituting live patientfollow-ups for digital photographs. However,photographs were taken in a standardisedmanner and photograph evaluation was sup-ported by the live assessment by the patientitself and the physician. In turn, the potentiallysubjective assessment by patient and physi-cian who were not blind to the technique usedwas confirmed by the blind observers enablingoverall a reliable evaluation.

CONCLUSIONOverall, this study clearly shows that thenew wound closure device Leukosan® Skin-Link represents a valid alternative to tradi-tional suturing for surgically inflicted incisions.Leukosan® SkinLink was comparable with theinvasive method of suturing in all aspects



investigated. The cosmetic outcomes as well aswound closure performance were comparablefor both techniques, leaving patients and physi-cians with an additional non invasive optionfor wound closure in the operating room.

ACKNOWLEDGEMENTSFinancial support and Leukosan® SkinLinkwas provided by BSN medical GmbH (Ham-burg, Germany). None of the authors isemployed by BSN. No author accepted anygift, entertainment, service, loan or promise offuture benefits from BSN or has any benefi-cial interest in, or substantial obligation to thecompany or the device SkinLink.

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A randomized, controlled study comparing the cosmetic outcome of a new wound closure device with Prolene suture closing caesarean wounds