prevent scar spread

STUDY

Prevention of Scar Spread on Trunk Excisions

A Rater-Blinded Randomized Controlled Trial

Kevin F. Kia, MD; Molly V. Burns, MD; Travis Vandergriff, MD; Sarah Weitzul, MD

Importance: Wounds that heal under tension lead towider and more conspicuous scars and result in de-creased long-term patient satisfaction. We hypoth-esized that prolonged intradermal suture lifetime can de-crease scar spread in wounds under tension.

Objective: To determine whether prolonged intrader-mal support would help decrease scar spread.

Design: Prospective, randomized, controlled, rater-blinded, split-scar trial.

Setting: Outpatient dermatology clinic at Dallas Veter-ans Affairs Hospital, Dallas, Texas.

Patients: Patients presenting with skin cancer on thetrunk were considered for the trial. We included 25 dis-tinct surgical sites on a total of 22 patients.

Intervention: After excision, the wounds were closedwith polyglactin 910 and poly-4 hydroxybutyrate (P4HB)sutures in opposite halves of the same wound.

Main Outcome Measures: Quantitative scar spreadat 12 months and qualitative assessment using a

visual analog scale and Hollander Wound EvaluationScale.

Results: We found a statistically significant difference inscarwidth between the 2 suturematerials, with ameandif-ference of 2.3 (95% CI, 1.0-3.6) mm (P .001) favoringP4HB. A clinically significant difference on the visual ana-log andHollanderWoundEvaluation scaleswas not iden-tified. Suture reactions were more common with P4HB.

Conclusions and Relevance: Prolonged intradermalsuture support leads to significantly decreased scar spread.However, the use of a longer-acting absorbable suture in-creases the rate of suture reaction noted at 3months. Fur-ther studies into less reactive, longer-acting biomaterialsare needed. In clinical practice, excisions in high-tensionareas that are classically known to spreadover timecanben-efit from longer-acting intradermal sutures.

Trial Registration: clinicaltrials.gov Identifier:NCT00938691

JAMA Dermatol. 2013;149(6):687-691.Published online April 17, 2013.doi:10.1001/jamadermatol.2013.3004

T HE AESTHETIC OUTCOME OFa scar after surgery for skincancer has been shown tobe themost important pre-dictor of a patients overallassessment of skin cancer treatment.1 Ahigher level of patient dissatisfaction hasbeen noted with wounds on the trunkcompared with the face.1-3 Truncal scarsare known to spread with time, likely sec-ondary to the greater tension inherent tothis body area.4 Orientating a scar alongthe Langer lines is known to reduce ten-sion and improve scar outcome, whereasscars orientated against these lines are sub-ject to increased widening.5

In the bilayer closure of surgicalwounds, buried intradermal sutures areplaced to approximate wound edges while

relieving direct tension from the epider-mis. Sutures are also placed superficiallyto align epidermal edges, and these su-tures are generally removed after 1 to 2weeks. At that time, the wound has at-tained only 10% of its initial tensilestrength. The absorbable intradermal su-tures are left in place to support thewoundas it develops a more robust collagen net-work. The absorbable suture most com-monly used by US dermatologic sur-geons is polyglactin 910.6 This sutureretains 50% of its strength at 3 weeks af-ter placement and is effectively gone by 6weeks. At 6 weeks, the healing wound hasattained only 45% of its original strength.

Wehypothesize that this duration of in-tradermal support is insufficient forwounds under high tension and may cre-

Author AffDepartmenThe UniverSouthwesteand DallasHospital, DVandergriffThe UniverScience Cen(Dr Burns)the DepartmThe UniverSouthwesteDallas.

Author Affiliations:Department of Dermatology,The University of TexasSouthwestern Medical Centerand Dallas Veterans AffairsHospital, Dallas (Drs Kia,Vandergriff, and Weitzul); andThe University of Texas HealthScience Center San Antonio(Dr Burns). Dr Burns is now atthe Department of Dermatology,The University of TexasSouthwestern Medical Center,Dallas.

JAMA DERMATOL/VOL 149 (NO. 6), JUNE 2013 WWW.JAMADERM.COM687

2013 American Medical Association. All rights reserved.

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ate circumstances favoring scar spread. If this hypoth-esis is true, prolonged intradermal support would helpto decrease scar spread. To test this hypothesis, we con-ducted a prospective trial comparing polyglactin 910withthe novel long-acting absorbable suture material poly-4hydroxybutyrate (P4HB). A naturally occurring polyes-ter produced by bacterial fermentation, P4HB is ap-proved by the US Food andDrug Administration for soft-tissue ligation and approximation. The suture consistsof a translucent monofilament that is reported to haveinitial tensile strength comparable to that of polydioxa-none. The key characteristic of this new suture materialis its retention of tensile strength; at 24weeks after place-ment, thematerial retains 30% of its original strength andis not completely resorbed until 1 year.

METHODS

We used a single-center, prospective, randomized, rater-blinded clinical trial design to evaluate whether extended in-tradermal support would have a clinically significant effect onscar outcome.Written informed consent was obtained from allpatients, and the study was approved by the institutional re-view board of the Dallas Veterans Affairs Hospital. We fol-lowed the protocols of the Declaration of Helsinki during thestudy. All veterans presenting to the dermatology clinic at theDallas Veterans Affairs Hospital with biopsy-proven skin can-cer located on the upper trunk necessitating local excisionwereeligible for the trial. Exclusion criteria included current orplanned pregnancy; current breast-feeding; a history of ioniz-ing radiation therapy, keloid or hypertrophic scarring, bleed-ing, or a collagen or an elastin disorder; current internal ma-lignant disease; and current use of immunosuppressants.Participants received financial compensation for completion of

the study. Patient enrollment took place fromMarch 1 to June30, 2009.

A split-repair design was created by repairing one-half ofthe elliptical excision with 3-0 intradermal polyglactin 910 andthe other half with 3-0 intradermal P4HB. The side to whichthe specific suture was assigned was randomized (using a ran-dom number generator [http://www.random.org]), and thehalves were designated as sides A and B. A polypropylene su-ture was used to align epidermal edges in each closure. Eachwound was repaired by the same dermatologist (K.F.K.). Al-location of suture sidewas kept in a sealed envelope by the clinicsupport staff and not revealed to the surgeon until after the pa-tient had consented to and been positioned for the procedure.The patient was not able to physically visualize which sutureswere being used and was never informed of the randomizationallocation.

The primary outcome measure was scar width, measured inmillimeters. Width was measured using standardized high-resolution photographs by a blinded reviewer (T.V.). A separatemeasurementwas also obtained in person (byK.F.K.). Scarwidthwas measured using calipers at the midpoint of each half of thewound. Secondary outcomemeasures includedmeasurement ofscar aesthetics by blinded dermatologists (T.V. and S.W.) apply-ing theHollanderWoundEvaluationScale (HWE)andvisual ana-log scale (VAS). TheHWEaddressed the following 5 clinical vari-ables: width greater than 2mm, presence or absence of elevation,color, presence or absence of hatch marks, and overall appear-ance. A score of 5 is the best possible score. TheVAS is a 100-mmline with the worst possible scar represented by a score of 0, lo-cated at the far left end, and the best possible scar represented bya score of 100, located at the far right end. The HWE7 and VAS8

have been previously validated for use on photographs of scars.The scores assigned by both reviewers were averaged. All mea-surements were taken at 3 and 12months after surgery. Adverseevents, such as pruritus, pain, infection, suture reaction, dehis-cence, and bleeding or hematoma,were also recorded and treatedappropriately.

A power analysis performedbefore enrollment predicted that,with 25 participants (and an expected dropout rate of20%),the study would have greater than 80% power to detect a 1-mmreduction in scar width. The studywould have greater than 90%power to detect a 15-mm difference on the VAS and a 1-U dif-ference on the HWE. These values were previously deter-mined to represent the mean numerical differences indicativeof a clinically significant difference.7,8 We used a paired t testfor all continuous variables. Unless otherwise indicated, dataare expressed as means (with 1 SD).

RESULTS

During the study, we examined 25 lesions on a total of22 participants, with all lesions located on the back(Figure 1). Two patients were unavailable for fol-low-up before the 3-month postoperative examination(1 death from pneumonia and 1 patient becoming home-less). Consequently, data from the remaining 23 lesionswere used for a per-protocol statistical analysis. The pa-tientswere allmen,with amean age of 68 years. Themeanexcision diameter was 2.3 cm, and the mean final lengthof closure was 7.2 cm. The 23 patients who remained inthe trial were included in all statistical analyses (Table).

The scar spread measured by rater-blinded reviewof standardized photographs was found to be signifi-cantly different between the 2 halves at both assess-ments. At the 3-month analysis, the P4HB sutures had

1 Excluded1 Did not meet inclusion criteria

22 Allocated to intervention B22 Received allocated

intervention

22 Allocated to intervention A22 Received allocated

intervention

2 Lost to follow-up 2 Lost to follow-up

20 Underwent analysis 20 Underwent analysis

23 Underwent assessment for eligibility

22 Randomized

Figure 1. Patient flowchart using CONSORT criteria. A total of 22participants were enrolled in the study and intervention assignments wererandomized. Because 3 participants had multiple (2) wounds (sites ofintervention), a total of 25 wounds were enrolled in the study. Allocationconsisted of wound suturing with polyglactin 910 (intervention A) andwound suturing with poly-4 hydroxybutyrate (intervention B). All woundsreceived interventions A and B in a split-scar design, with each wounddivided into halves and individual halves assigned a suture material in arandom fashion. Two participants were lost to follow-up before the finalfollow-up period; one died of pneumonia, and the other was homeless. Thetotal number of participants undergoing analysis was 20.




a mean spread of 0.7 (0.7) mm and the polyglactin910 had a mean spread of 1.7 (2.5) mm. The mean dif-ference between these 2 scar spreads was 0.98 (1.61)(95% CI, 0.28-1.67) mm (P = .008). At 12 months, themean scar spread for PH4B was 0.9 (1.5) mm andfor polyglactin 910 it was 3.2 (4.3) mm, with a meandifference of 2.3 (3.0) (95% CI, 1.0-3.6) mm(P .001) (Figure 2 and Figure 3).

At 3 months, the VAS and HWE were used to evalu-ate the scar as a secondary outcome. The VAS resultedin a score of 69 for P4HB sutures and 62 for polyglactin910 sutures, with a mean difference of 7 (14) (95% CI,1-13) mm (P = .03). The HWE results yielded a scoreof 4.2 for P4HB and 3.8 for polyglactin 910 sutures, re-sulting in a mean difference of 0.4 (0.9) (95% CI, 0.4to 0.8) (P = .07). At 12months, theVAS resulted in a scoreof 72 for P4HB and 62 for polyglactin 910 sutures, with amean difference of 10 (12) (95%CI, 4-15)mm(P = .001).The HWE results yielded a score of 4.0 for P4HB and 3.7for polyglactin 910 sutures, resulting in a mean differ-ence of 0.3 (0.7) (95% CI, 0.1-0.6) (P = .02). Althoughstatistically significant, none of these secondary out-come measures reached the previously validated defini-tion of clinical significance.

The blinded review of the scars was performed viaphotographs. Variability may exist between the photo-graphic measurements and direct patient measure-ments. In this study, each half of the wound was com-pared directly with the other half, giving increasedinternal validity and significance to any differencenoted in the photographs. In addition, an in-personmeasurement was conducted by the primary investiga-tor (K.F.K.). These measurements were analyzed sepa-rately from those of the blinded reviewers and showedsimilarly statistically significant decreases in scarspread in favor of the longer-acting suture. At 3months, the PH4B sutures had a mean scar spreadof 0.5 (0.6) mm and the polyglactin 910 sutures had amean scar spread of 1.4 (2.5) mm. The mean differ-ence between these 2 scar spreads was 0.9 (2.0) mm(P = .054). At 12 months, the mean scar spread

for PH4B sutures was 0.8 (1.3) mm and for polyglactin910 sutures it was 2.3 (2.7) mm, with a mean differ-ence of 1.5 (2.3) mm (P = .004). We found no statisti-cally significant difference between the mean differ-ences noted by the primary investigator and theblinded reviewer.

Complications were classified asminor andmajor, de-pending on whether they were symptomatic to the pa-tient. The side sutured with P4HB included 8 complica-tions (35% of the 23 wounds analyzed). Seven of thesecomplicationswereminor asymptomatic focal areas of ery-thema suggestive of local suture reaction. One reactiondefined as major was a significantly inflamed suture re-action with sterile abscess formation and drainage. Twocomplicationswere noted on the polyglactin 910 side (9%of 23 wounds analyzed). One minor asymptomatic vis-ible suture reactionwas noted. One additional patient re-ceiving aspirin and warfarin sodium developed a hema-toma; however, his secondary dehiscencewas completelyisolated to the side of the wound with polyglactin 910sutures.

Table. Primary and Secondary Outcome Measure Resultsa

P4HBSuture

Polyglactin910 Suture Difference

PValue

Scar spread, mm3 mo 0.7 (0.7) 1.7 (2.5) 1.0 (1.6) .008b

12 mo 0.9 (1.5) 3.2 (4.3) 2.3 (3.0) .001b

HWEc

3 mo 4.2 (1.1) 3.8 (1.3) 0.4 (0.9) .0712 mo 4.0 (1.2) 3.7 (1.4) 0.3 (0.7) .02d

VAS, mme

3 mo 69 (16) 62 (17) 7 (14) .03d

12 mo 72 (13) 62 (19) 10 (12) .001d

Abbreviations: HWE, Hollander Wound Evaluation Scale; P4HB, poly-4hydroxybutyrate; VAS, visual analog scale.

aUnless otherwise specified, data are expressed as mean (SD).b Indicates a statistically significant difference.c Indicates measured on a scale of 1 to 5.d Indicates a statistically significant difference, but that difference did not

reach a predetermined clinical significant difference.e Indicates measured on a scale of 1 to 100 mm.

0

0 1.0 1.5 2.0 2.5 3.0 3.5 4.0

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10 S

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Figure 2. Scar spread over time. Points represent individual patients with thewidth of scar spread on the poly-4 hydroxybutyrate (P4HB) half plottedon the x-axis and on the polyglactin 910 half plotted on the y-axis. Thediagonal reference line represents equal widths of both sides. Points abovethis line represent patients whose scars were wider on the polyglactin sidecompared with the P4HB side. A, Scar spread at 3 months after surgery.B, Scar spread at 12 months after surgery.




COMMENT

In the choice of suture for high-tension wounds, a sur-geon must consider not only the initial tensile strengthnecessary to bring the wound together but also the du-ration of action to keep the wound supported over time.The most commonly used suture in dermatologic sur-gery, polyglactin 910, provides excellent initial tensilestrength but does not retain sufficient integrity to pre-vent long-term scar spread in high-tension wounds. Ourstudy demonstrates that prolonged intradermal supportis necessary to decrease scar spread.

Many studies have attempted to examine the relation-ship between scar spread and tension in a wound. Au-thors have attempted to prove this relationship by com-paring single- vs double-layer closure. In a randomizedcontrolled trial,9 a comparisonbetween single- anddouble-layer closure in facial lacerations showed no significantdifference in scar outcome. A similar study10 evaluated17 postlaminectomywounds and foundno significant dif-ference in scar width after 2 to 3 months regardless ofintradermal sutures. A study in Japan comparing 20 in-guinal wounds repaired with polydioxanone and nylonsutures found no significant difference in scar width.11

Chantarasak et al12 found little difference in scar qualitybetween polyglycolic acid and polydioxanone sutures inwounds under minimal tension. The common variableamong these studies is that their closure was conducted

on lacerations and incisional wounds, both of which ex-ist underminimal tension. This scenario is different thanmost cutaneous oncologic surgery inwhich adjacent skinis being stretched to cover a defect.

Several studies support the idea that wounds undertensionheal betterwithmore intradermal support. A studywith methods similar to those of the present study com-pared scar quality after closingwounds under tensionwithpolyglycolic acid or polydioxanone.13 Polyglycolic acid,having a much shorter duration of action, produced sig-nificantly wider scars. Another study by Wray14 foundthat scarwidth and appearance correlatedwith the amountof tension required to close skin incisions after breast re-construction.

Our study has several limitations that merit discus-sion. First, this studywas performed in a uniformlywhitepopulation, and therefore the results may not general-ize to other skin types. In addition, the follow-upreported herein was restricted to 1 year after surgery. Ad-ditional follow-up may be necessary to determine long-term scar appearance.

The visible suture reactions were significantly morecommon on the P4HB side than on the polyglactin 910side. Most of these reactions were asymptomatic to thepatient (ie, erythematous macule visible within scar line[Figure 4]). However, a similar reaction on a more vis-ible area (the face or extremities) may have been moredistressing to the patient. In addition, 1 patient had a verysignificant inflammatory response on the P4HB side lead-ing to a significantly poorer outcome, with a VAS of lessthan 10 of 100. This result demonstrates that, even if aninflammatory reaction is infrequent, its consequences canbe clinically significant.

Overall, this study demonstrated significantly de-creased scar spread favoring the longer-acting absorb-able P4HB sutures. However, the use of a longer-actingabsorbable suture increased the rate of suture reactionnoted at 3 months. This study serves as proof that pro-longed intradermal support will reduce scar spread inhigh-tension areas. Further studies into less reactive, lon-ger-acting biomaterials are needed.

Accepted for Publication: December 6, 2012.Published Online: April 17, 2013. doi:10.1001/jamadermatol.2013.3004Correspondence:Kevin F. Kia, MD, Department of Der-matology, The University of Texas Southwestern Medi-cal Center, 5323 Harry Hines Blvd, Dallas, TX 75390-9069 ([email protected]).Author Contributions: Dr Kia had full access to all thedata in the study and takes responsibility for the integ-rity of the data and the accuracy of the data analysis. Studyconcept and design:Kia, Vandergriff, andWeitzul. Acqui-sition of data: Kia and Vandergriff. Analysis and interpre-tation of data:Kia, Burns, and Vandergriff.Drafting of themanuscript: Kia, Burns, Vandergriff, and Weitzul. Criti-cal revision of themanuscript for important intellectual con-tent:Kia, Burns, Vandergriff, andWeitzul.Obtained fund-ing: Kia. Administrative, technical, and material support:Kia, Burns, and Vandergriff. Study supervision: Kia,Vandergriff, and Weitzul.Conflict of Interest Disclosures: None reported.

Figure 3. Two representative scars at 1 year after surgery demonstrating atypical difference in scar spread. Thinner scars are seen on the wound halvessutured with poly-4 hydroxybutyrate (side A) compared with polyglactin 910(side B).

Figure 4. Example of suture reaction, an erythematous macule visible withinthe scar line, at 3 months within the poly-4 hydroxybutyrate (side B) half of awound.




Funding/Support: This study was supported by a grantfrom the American Society of Dermatologic Surgery. Su-tures samples (P4HB) were donated by Tepha, Inc.Role of the Sponsors: The sponsors had no role in the de-sign and conduct of the study; in the collection, analysis,and interpretation of data; in the preparation of themanu-script; or in the review or approval of the manuscript.

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2. Kearney CR, Holme SA, Burden AD, McHenry P. Long-term patient satisfactionwith cosmetic outcome of minor cutaneous surgery. Australas J Dermatol. 2001;42(2):102-105.

3. AlamM, Posten W, Martini MC, Wrone DA, Rademaker AW. Aesthetic and func-tional efficacy of subcuticular running epidermal closures of the trunk and ex-tremity: a rater-blinded randomized control trial. Arch Dermatol. 2006;142(10):1272-1278.

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5. Larrabee WF, Sherris DA, eds. Principles of Facial Reconstruction. Philadel-phia, PA: Lippincott-Raven; 1995.

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8. Quinn JV, Drzewiecki AE, Stiell IG, Elmslie TJ. Appearance scales to measure cos-metic outcomes of healed lacerations. Am J Emerg Med. 1995;13(2):229-231.

9. Singer AJ, Gulla J, Hein M, Marchini S, Chale S, Arora BP. Single-layer versusdouble-layer closure of facial lacerations: a randomized controlled trial. Plast Re-constr Surg. 2005;116(2):363-370.

10. Winn HR, Jane JA, Rodeheaver G, Edgerton MT, Edlich RF. Influence of subcu-ticular sutures on scar formation. Am J Surg. 1977;133(2):257-259.

11. Ichiro H, Hideki N, Hiroaki N, Shinji T. A clinical comparison of scar qualities usingPDS II versus nylon subcuticular sutures. Keisei Geka. 2000;43:713-717.

12. Chantarasak ND, Parys BT, Barr H, Chatlani P, Gana J. Subcuticular polydioxa-none or polyglycolic acid skin closure in clean andpotentially contaminatedwounds.Clin Mater. 1988;3(3):191-194.

13. Chantarasak ND, Milner RH. A comparison of scar quality in wounds closed un-der tension with PGA (Dexon) and polydioxanone (PDS). Br J Plast Surg. 1989;42(6):687-691.

14. Wray RC. Force required for wound closure and scar appearance. Plast Recon-str Surg. 1983;72(3):380-382.




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