Original Article 159

Authors

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

Aliation

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

Key words
wound closure

laparoscopy

port-site incisions

cosmetic outcome

children

Abstract

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:
159162 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
Philipp_Romero@med.uniheidelberg.de

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 complications and a better cosmetic result compared to
trans- or only subcutaneous sutures, the choice
of technique is still often based on the surgeons
personal experience. Thus, the objective of this
trial was to assess the impact of tissue adhesives (Dermabond) compared to adhesive
strips (Steri-Strip) on potential complications
of wound healing, wound pain, cosmetic outcome, 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 (40
Vicryl). Postoperative complications, pain, and
patient satisfaction with scars were evaluated at

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 refined
over the past several years. In addition to intracuticular sutures, no needle techniques such as
tissue adhesives and adhesive strips are also frequently used by pediatric surgeons worldwide to
approximate wound edges and achieve satisfactory healing. Tissue adhesives (Dermabond),
which bind to skin surfaces via a polymerization
reaction, have a good tensile strength, are bactericidal and bacteriostatic, have negligible histo-

follow-up on day 10 and day 90 after the operation 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 significant dierence
between the 2 groups with regard to the cosmetic 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 differences between the 2 methods as regards the
result of patient evaluations (p > 0.05). Only one
wound infection (4 %) was observed in the SteriStrip 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 adhesive strips are excellent no needle alternatives
for the closure of laparoscopic port-site incisions
in children. As regards cosmetic outcome, SteriStrip wound closure seems to be the most suitable and is also the less expensive technique.

toxicity, and peel o spontaneously [1, 2].

Adhesive strips (Steri-Strip) have reinforcing
filaments 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 similar risk of infection as sutures do [35]. The
choice of techniques is often based on the surgeons personal experience and the choice
between these 2 no needle options as the ideal
method for closing laparoscopic wounds is still
controversially discussed.

Romero P et al. Prospective, Randomized, Controlled Trial Eur J Pediatr Surg 2011; 21: 159162

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Prospective, Randomized, Controlled Trial Comparing

a Tissue Adhesive (Dermabond) with Adhesive Strips
(Steri-Strips) for the Closure of Laparoscopic Trocar
Wounds in Children

The purpose of this pilot study therefore was to compare postoperative complications, cosmetic outcome, and patient satisfaction 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 20072008 were included in this prospective, 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 presence of concomitant chronic diseases (e. g. diabetes mellitus),
immunosuppression, malignancies, and conversion to laparotomy or intraoperative enlargement of incisions for intact specimen extraction.
For randomization, a computer-generated randomization pattern 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, respectively, just lateral to the deep inferior epigastric vessels. The
appendix was dissected between 3 ligature loops using laparoscopic 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 20 purse-string stitches. Subcutaneous sutures were performed using inverted Vicryl 40 absorbable sutures. The wound edges were manually approximated
using either fingertips 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 microbiological reports. In-hospital complications of wound healing
were recorded. All patients were asked not to remove suture
material. The Dermabond peeled o spontaneously. The SteriStrips were removed after 10 days.
Follow-up examinations were carried out on the 10th and 90th
postoperative day. If complications developed, control examinations 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 infections, wound dehiscence, and any other adverse events associated with the wound. Wound infection was defined as abscess or
redness > 3 mm perpendicular to incision.

Postoperative pain during rest at port sites was evaluated on the

90th postoperative day using a dichotomous question. The location of wound pain at the umbilicus or at the left and right iliac
fossa was registered as well.
To facilitate a comparison between dierent wound closure
techniques, patients were asked a dichotomous question to
judge their satisfaction with the cosmetic results of the scars on
Table 1). In the Steri-Strip Group, 24 of 25
day 10 and 90 (
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
Table 2).
Group (
Statistics for all variables were calculated using SPSS Version
16.0. Dierences between groups for dichotomous variables
were assessed using a 2-sided Fishers exact test and analysis of
variance (ANOVA) or t-test for unequal variances. The level of significance 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 %)
Steri-Strip
(n = 20)
1 (5 %)

5 (21.7 %)
Dermabond
(n = 22)
3 (13.6 %)

Day 90 follow-up
dissatisfaction with cosmetic result**
* Fishers exact test, p = 0.24
** Fishers exact test, p = 0.6

Table 2 Cosmetic outcome at 90 day follow-up.

cosmetic rating
surgeon 1. mean [SD]
surgeon 2. mean [SD]
average of 2 evaluators*
mean [SD]
median

Steri-Strip

Dermabond

(n = 21)

(n = 22)

20.9 [7.7]
21.3 [9.7]

28.3 [12.2]
29.5 [10.2]

21.1 [8.3]
16.6

28.9 [10.4]
31.2

* ANOVA (analysis of variance) p = 0.01

Table 3 Baseline demographics.

gender
male
female
age, mean, [SD], years
BMI*, mean, [SD]
diagnosis
acute appendicitis
phlegmonous appendicitis
perforated appendicitis
* ANOVA (analysis of variance), p = 0.69

Romero P et al. Prospective, Randomized, Controlled Trial Eur J Pediatr Surg 2011; 21: 159162

Steri-Strip

Dermabond

(n = 25)

(n = 24)

16 (64 %)
9 (36 %)
11.1 [2.3]
18.6 [3.0]

13 (54.2 %)
11 (45.8 %)
11.2 [2.5]
19.0 [3.2]

10 (40 %)
11 (44 %)
4 (16 %)

8 (33.3 %)
10 (41.7 %)
6 (25 %)

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160 Original Article

graded by surgeons on day 90 after wound closure was defined

as the primary endpoint. Thus, null hypothesis means no dierence 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 defined 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 n1 = 21 (Steri-Strip Group) and n2 = 22 (Dermabond
Group) was sucient to reject the null hypothesis using the
t-test for unequal variances. For arising delta = 8 and standard
deviations S1 = 8 and S2 = 10, dierences were detected with an
Table 2). Postoperative
alpha level of 5 % and a power of 0.86 (
pain at port sites, wound infections, wound dehiscence and
patient satisfaction with the cosmetic results of the scars were
defined as secondary endpoints.

Results

A total of 49 patients (24 Dermabond, 25 Steri-Strip) were

enrolled between August 2007 and August 2008. No dierences
in diagnosis, gender, age, or BMI (body mass index) were
observed between the 2 groups. Baseline demographics are dis Table 3.
played in
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 moistening 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 (Fishers exact test, p = 0.52).
The cosmetic outcomes as assessed by the surgeons are shown
Table 2.
in
There was a significant dierence in the cosmetic score at follow-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
dierentiated according to closure technique at follow-up on
Table 1.
day 10 and day 90 is shown in
There was no statistical dierence between groups with regard
to subjective dissatisfaction with the cosmetic results.

Discussion

Transcutaneous suturing of laparoscopic port sites has represented 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 first prospective 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 cosmetic results of dierently 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, dierent methods for the wound closure of laparoscopic port-site incisions have been investigated in prospective
randomized studies, comparing suture techniques with adhesive 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 (Fishers 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, randomized, 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 Dermabond 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 findings, there was no dierence 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 significant dierence in the mean visual analogue scale for cosmetic 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 dierences in follow-up time, wound location, and
cause of wounds.
One very remarkable finding of our study was that no statistical
dierence between groups was found regarding subjective dissatisfaction 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 satisfaction with the cosmetic results of Steri-Strip closure at 3month follow-up are comparable to our findings, with a
subjective dissatisfaction with the cosmetic results reported for
2 of 23 cases (8.7 %).
In conclusion, both tissue adhesives and adhesive strips represent excellent alternatives for the closure of laparoscopic portsite incisions in children. As regards cosmetic outcome,
Steri-Strip wound closure seems to be the most suitable and
moreover is the less expensive technique.

Conflict of Interest: None

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162 Original Article

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Romero P et al. Prospective, Randomized, Controlled Trial Eur J Pediatr Surg 2011; 21: 159162