prospective, randomized, controlled trial comparing a tissue adhesive (dermabond™) with adhesive...

Original Article 159

Romero P et al. Prospective, Randomized, Controlled Trial Eur J Pediatr Surg 2011; 21: 159 162

received November 18, 2010 accepted after revision November 20, 2010

Bibliography DOI http://dx.doi.org/ 10.1055/s-0030-1270458 Published ahead of print:31 January 2011 Eur J Pediatr Surg 2011; 21: 159 162 Georg Thieme Verlag KG Stuttgart New York ISSN 0939-7248

Correspondence Dr. Philipp Romero University of Heidelberg Department of Surgery Section Pediatric Surgery Im Neuenheimer Feld 110 69120 Heidelberg Germany Tel.: + 49 6221 566 283 Fax: + 49 6221 565 105 [email protected] heidelberg.de

Key words wound closure laparoscopy port-site incisions cosmetic outcome children

Prospective, Randomized, Controlled Trial Comparing a Tissue Adhesive (Dermabond ) with Adhesive Strips (Steri-Strips ) for the Closure of Laparoscopic Trocar Wounds in Children

toxicity, and peel o spontaneously [1, 2] . Adhesive strips (Steri-Strip ) have reinforcing fi laments and represent another alternative to sutures. Both methods are easy to apply and require only minimal training and expertise by the physician. Several comparative studies have shown that less time is required to apply either tissue adhesives or adhesive strips than to create sutures to complete a procedure and that these tissue adhesives and adhesive strips have a simi-lar risk of infection as sutures do [3 5] . The choice of techniques is often based on the sur-geon s personal experience and the choice between these 2 no needle options as the ideal method for closing laparoscopic wounds is still controversially discussed.

Introduction A laparoscopic approach as a minimally invasive procedure to treat acute appendicitis represents one of the most common operations in pediatric surgery. Like surgical approaches, the methods of closing surgical incisions have also been refi ned over the past several years. In addition to intracu-ticular sutures, no needle techniques such as tissue adhesives and adhesive strips are also fre-quently used by pediatric surgeons worldwide to approximate wound edges and achieve satisfac-tory healing. Tissue adhesives (Dermabond ), which bind to skin surfaces via a polymerization reaction, have a good tensile strength, are bacte-ricidal and bacteriostatic, have negligible histo-

Authors P. Romero , G. Frongia , S. Wingerter , S. Holland-Cunz

A liation University of Heidelberg, Department of Surgery, Section Pediatric Surgery, Heidelberg, Germany

Abstract Background: 4 methods are used in pediatric laparoscopic surgery to close trocar wounds. While tissue adhesives or adhesive strips have been shown to produce fewer wound complica-tions and a better cosmetic result compared to trans- or only subcutaneous sutures, the choice of technique is still often based on the surgeon s personal experience. Thus, the objective of this trial was to assess the impact of tissue adhe-sives (Dermabond ) compared to adhesive strips (Steri-Strip ) on potential complications of wound healing, wound pain, cosmetic out-come, and patient satisfaction after laparoscopic appendectomy in children. Methods: 49 patients undergoing laparoscopic appendectomy were enrolled in this prospective randomized trial. In every patient, two 5-mm and one 10-mm port-site incision was closed either with Dermabond or Steri-Strip after placing subcuticular absorbable sutures (4 0 Vicryl ). Postoperative complications, pain, and patient satisfaction with scars were evaluated at

follow-up on day 10 and day 90 after the opera-tion using a questionnaire and a visual analogue scale (VAS). Photographs of scars taken on day 90 were evaluated on a VAS by 2 pediatric surgeons blinded to the closure method used. Results: According to the surgeons evaluation of the cosmetic outcome, a signifi cant di erence between the 2 groups with regard to the cos-metic score was found on day 90 of follow-up, favoring Steri-Strip wound closure (p < 0.05). On day 10 and 90 there were no statistical dif-ferences between the 2 methods as regards the result of patient evaluations (p > 0.05). Only one wound infection (4 % ) was observed in the Steri-Strip group (n = 25) on day 10. At follow-up on day 90 two patients (9.1 % ) in the Dermabond group and one (4.8 % ) in the Steri-strip group complained of wound pain (p = 0.52). Conclusions: Both tissue adhesives and adhe-sive strips are excellent no needle alternatives for the closure of laparoscopic port-site incisions in children. As regards cosmetic outcome, Steri-Strip wound closure seems to be the most suit-able and is also the less expensive technique.

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The purpose of this pilot study therefore was to compare post-operative complications, cosmetic outcome, and patient satis-faction with scars from trocar wounds after laparoscopic surgery in children using Steri-Strip or Dermabond .

Patients and Methods A total of 49 consecutive children between 5 and 15 years of age undergoing standardized laparoscopic appendectomy in our department in the years 2007 2008 were included in this pro-spective, randomized, single-center trial. This study was reviewed and approved by the appropriate Institutional Review Board. Detailed informed consent was obtained from all patients and parents preoperatively. Exclusion criteria included the pres-ence of concomitant chronic diseases (e. g. diabetes mellitus), immunosuppression, malignancies, and conversion to laparo t-omy or intraoperative enlargement of incisions for intact speci-men extraction. For randomization, a computer-generated randomization pat-tern was implemented and patients were intraoperatively assigned to a procedure by means of a blind envelope system. The laparoscopic appendectomy technique was standardized using a 10-mm trocar (Karl Storz GmbH, Tuttlingen, Germany) that was inserted after making a semilunar incision with a mini laparotomy underneath the umbilicus. Two 5-mm ports (Karl Storz) were each placed in the left and right iliac fossa, respec-tively, just lateral to the deep inferior epigastric vessels. The appendix was dissected between 3 ligature loops using laparo-scopic scissors and removed without wound contact either through the 10-mm trocar or using a recovery bag (Ethicon). The trocars were retracted and the abdominal fascia at the umbilicus was sutured using PDS 2 0 purse-string stitches. Subcutane-ous sutures were performed using inverted Vicryl 4 0 absorb-able sutures. The wound edges were manually approximated using either fi ngertips or forceps. Dermal wounds were closed by applying either 4 adhesive strips (Steri-Strip ; 3M Medica, Neuss, Germany) in a star-shaped manner on each wound or 2-octylcyanoacrylate (Dermabond ; Ethicon, Norderstedt, Germany) according to randomization done prior to surgery. All surgeons (4 residents and 3 senior physicians) had experience in performing both wound closure techniques. Postoperatively, antibiotic therapy with cefotaxime (Claforan ; Anofi -Aventis GmbH, Frankfurt, Germany) and metronidazole (Clont ; B. Braun AG, Melsungen, Germany) was administered intravenously. In cases of phlegmonous appendicitis, antibiotic therapy was given for 3 (Claforan ) or one day (Clont ). In cases of perforated appendicitis, antibiotic therapy was given for 7 and 5 days. If required, antibiotics were adjusted according to micro-biological reports. In-hospital complications of wound healing were recorded. All patients were asked not to remove suture material. The Dermabond peeled o spontaneously. The Steri-Strips were removed after 10 days. Follow-up examinations were carried out on the 10 th and 90 th postoperative day. If complications developed, control examina-tions were performed in the interim. Follow-up included clinical investigation and a questionnaire to assess satisfaction with the cosmetic results, postoperative pain at port sites, wound infec-tions, wound dehiscence, and any other adverse events associa-ted with the wound. Wound infection was defi ned as abscess or redness > 3 mm perpendicular to incision.

Postoperative pain during rest at port sites was evaluated on the 90 th postoperative day using a dichotomous question. The loca-tion of wound pain at the umbilicus or at the left and right iliac fossa was registered as well. To facilitate a comparison between di erent wound closure techniques, patients were asked a dichotomous question to judge their satisfaction with the cosmetic results of the scars on day 10 and 90 ( Table 1 ). In the Steri-Strip Group, 24 of 25 patients answered this question on day 10 and 20 patients on day 90. In the Demabond Group, 23 of 24 patients were included on day 10 and 22 patients on day 90 for the follow-up questionnaire. Using a visual analogue scale (0 = best scar, 100 = worst scar) according to Guyuron and Vaughan [6] , the cosmetic outcome was also evaluated using macrophotos of each scar (3 photos per patient) taken on day 90 after wound closure. This assessment was completed by 2 pediatric surgeons blinded to the method of wound repair. Photographs were taken from 21 patients in the Steri-Strip Group and from 22 patients in the Dermabond Group ( Table 2 ). Statistics for all variables were calculated using SPSS Version 16.0. Di erences between groups for dichotomous variables were assessed using a 2-sided Fisher s exact test and analysis of variance (ANOVA) or t -test for unequal variances. The level of sig-nifi cance in this pilot trial was p 0.05. The cosmetic result

Table 1 Follow-up data on patient satisfaction with scars.

Steri-Strip Dermabond

Day 10 follow-up (n = 24) (n = 23)

dissatisfaction with cosmetic result * 2 (8.3 % ) 5 (21.7 % ) Steri-Strip Dermabond Day 90 follow-up (n = 20) (n = 22) dissatisfaction with cosmetic result * * 1 (5 % ) 3 (13.6 % ) * Fishers exact test, p = 0.24 * * Fishers exact test, p = 0.6

Table 2 Cosmetic outcome at 90 day follow-up.


(n = 21) (n = 22)

cosmetic rating surgeon 1. mean [SD] 20.9 [7.7] 28.3 [12.2] surgeon 2. mean [SD] 21.3 [9.7] 29.5 [10.2] average of 2 evaluators * mean [SD] 21.1 [8.3] 28.9 [10.4] median 16.6 31.2 * ANOVA (analysis of variance) p = 0.01

Table 3 Baseline demographics.


(n = 25) (n = 24)

gender male 16 (64 % ) 13 (54.2 % ) female 9 (36 % ) 11 (45.8 % ) age, mean, [SD], years 11.1 [2.3] 11.2 [2.5] BMI * , mean, [SD] 18.6 [3.0] 19.0 [3.2] diagnosis acute appendicitis 10 (40 % ) 8 (33.3 % ) phlegmonous appendicitis 11 (44 % ) 10 (41.7 % ) perforated appendicitis 4 (16 % ) 6 (25 % ) * ANOVA (analysis of variance), p = 0.69

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graded by surgeons on day 90 after wound closure was defi ned as the primary endpoint. Thus, null hypothesis means no di er-ence in the cosmetic results as graded by surgeons on day 90 after wound closure. Due to the lack of comparable studies we planed this analysis as a pilot trial with a defi ned sample size of n = 25 for each group. For power calculation we chose post-hoc power analysis. Post-hoc power analysis showed that a sample size of n 1 = 21 (Steri-Strip Group) and n 2 = 22 (Dermabond Group) was su cient to reject the null hypothesis using the t -test for unequal variances. For arising delta = 8 and standard deviations S 1 = 8 and S 2 = 10, di erences were detected with an alpha level of 5 % and a power of 0.86 ( Table 2 ). Postoperative pain at port sites, wound infections, wound dehiscence and patient satisfaction with the cosmetic results of the scars were defi ned as secondary endpoints.

Results A total of 49 patients (24 Dermabond , 25 Steri-Strip ) were enrolled between August 2007 and August 2008. No di erences in diagnosis, gender, age, or BMI (body mass index) were observed between the 2 groups. Baseline demographics are dis-played in Table 3 . Postoperative complications included wound infection, wound dehiscence, and pain at the wound sites. At short-term follow-up we did not encounter any wound dehiscence and detected only one (4 % ) case of wound infection in the Steri-Strip group on day 10. The wound infection was successfully treated by moist-ening the skin with a wound irrigation solution (Prontosan ; Braun Melsungen AG, Melsungen, Germany) using gauze swabs (Fink & Walter GmbH, Merchweiler, Germany) for 3 days. At the 90 day follow-up, 2 patients (9.1 % ) in the Dermabond group and one (4.8 % ) in the Steri-Strip group complained of wound pain during rest at the umbilicus (Fisher s exact test, p = 0.52). The cosmetic outcomes as assessed by the surgeons are shown in Table 2 . There was a signifi cant di erence in the cosmetic score at fol-low-up on day 90 between the 2 groups in favor of Steri-strip wound closure ( p = 0.01). The patients subjective satisfaction with the cosmetic results di erentiated according to closure technique at follow-up on day 10 and day 90 is shown in Table 1 . There was no statistical di erence between groups with regard to subjective dissatisfaction with the cosmetic results.

Discussion Transcutaneous suturing of laparoscopic port sites has repre-sented the standard procedure for wound closure for many years [7] . Since tissue adhesives and adhesive strips were developed, no needle wound closure of laparoscopic skin incisions is being increasingly applied. The ideal method to close laparoscopic skin incisions is still controversial, however. This is the fi rst prospec-tive randomized pilot trial comparing 2 no needle techniques using tissue adhesive and adhesive strips to close laparoscopic port sites in children. We focused on patients and surgeons satisfaction with the cos-metic results of di erently closed wounds. Moreover, we assessed postoperative complications such as wound infection, wound dehiscence, and pain at the wound sites. Only one case of

wound infection was observed among 25 trocar incisions for Steri-Strip wound closure (4 % ). According to other studies and data from the literature, complication rates after laparoscopic wound closure vary between 3 and 35 % [7, 8] . Recently, di erent methods for the wound closure of laparo-scopic port-site incisions have been investigated in prospective randomized studies, comparing suture techniques with adhe-sive strips or tissue adhesive octylcyanoacylate [4, 7] . Buchweitz et al. compared closing laparoscopic trocar wounds by transcutaneous vs. subcuticular suture or adhesive paper tape (Steri-Strip ). No case of wound pain was reported in the Steri-Strip group at the 3-month follow-up (n = 23). According to our results, 2 patients (n = 22, 9.1 % ) in the Dermabond group and one (n = 21, 4.8 % ) in the Steri-Strip group complained of wound pain during rest at the 3-month follow-up (Fisher s exact test, p = 0.52). Mattick et al. and Zempsky et al. [9, 10] compared the long-term cosmetic outcome of simple facial lacerations closed with 3M Steri-Strip skin closures or Dermabond in a prospective, ran-domized, controlled trial in children. Cosmetic outcomes for the 2 wound closure methods were equivalent as rated by 2 plastic surgeons blinded to the method of wound closure. In our trial we used a similar visual analogue scale to assess the cosmetic outcomes of laparoscopic lacerations closed with Derm-abond or Steri-Strips . Zempsky et al. evaluated cosmetic outcomes after 2 months. 89 patients were assessed (41 Steri-Strip , 45 Dermabond ). In contrast to our fi ndings, there was no di erence in the mean visual analogue scale for cosmetic scores (37.2 mm [Steri-Strip ] vs. 43.8 mm [Dermabond ]; p = 0.12). Our study showed a sig-nifi cant di erence in the mean visual analogue scale for cos-metic scores (21.1 mm [Steri-Strip ] vs. 28.9 mm [Dermabond ]; p = 0.01) for our patient group. These discrepancies to the study by Zempsky et al. may be related to di erences in follow-up time, wound location, and cause of wounds. One very remarkable fi nding of our study was that no statistical di erence between groups was found regarding subjective dis-satisfaction with the cosmetic results (5 % [n = 20, Steri-Strip ] and 13.6 % [n = 22, Dermabond]; p = 0.6). In the study conducted by Buchweitz et al. [11] , the results for patients subjective satis-faction with the cosmetic results of Steri-Strip closure at 3-month follow-up are comparable to our fi ndings, with a subjective dissatisfaction with the cosmetic results reported for 2 of 23 cases (8.7 % ). In conclusion, both tissue adhesives and adhesive strips repre-sent excellent alternatives for the closure of laparoscopic port-site incisions in children. As regards cosmetic outcome, Steri-Strip wound closure seems to be the most suitable and moreover is the less expensive technique.

Confl ict of Interest : None

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prospective, randomized, controlled trial comparing a tissue adhesive (dermabond™) with adhesive...

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