International Journal of Gynecology and Obstetrics 78 (2002) 201–205

Article
Episiotomy closure comparing enbucrilate tissue adhesive with
conventional sutures
M.L. Bowena,*, M. Selingerb
a
Department of Obstetrics and Gynaecology, Northampton General Hospital, Northampton, UK
b
Department of Obstetrics and Gynaecology, Royal Berkshire Hospital, Reading, UK

Received 25 January 2002; received in revised form 13 May 2002; accepted 13 May 2002

Abstract

Objectives: The purpose of the study was to evaluate the use of enbucrilate tissue adhesive compared with
subcuticular polyglycolic acid sutures in episiotomy wound closure. Methods: In a prospective controlled trial, two
groups were studied after undergoing an episiotomy skin wound repair using either enbucrilate tissue adhesive (ns
32) or a subcuticular polyglycolic acid suture (ns30). The variables measured included pain scores during selected
activities in the first 5 postnatal days, the time taken to become pain free after childbirth and the time taken to
resume pain free sexual intercourse. Suitable patients were invited by the midwives to participate in the trial. If they
gave consent to the trial, the gynecologist was contacted. If available, he would perform a repair using enbucrilate
tissue adhesive. If he was not available, one of the midwives would perform a repair using subcuticular polyglycolic
acid sutures. In this group, 90% of the women were recruited and sutured by one midwife. Results: Patients treated
with enbucrilate were found to have significantly less postnatal pain while walking, became pain free in a shorter
period (means25 days vs. 18 days; P-0.01) and were able to resume pain-free intercourse sooner (means34 days
vs. 52 days; P-0.001). Conclusions: Tissue adhesives incorporate the qualities of an ideal skin-closure material. The
results demonstrate their advantage over the current standard suture-based methods of repair in the perineum. The
use of adhesives merits further evaluation.
䊚 2002 International Federation of Gynecology and Obstetrics. Published by Elsevier Science Ireland Ltd. All rights
reserved.

Keywords: Episiotomy; Perineal repair; Tissue adhesive

1. Introduction prising given that adhesives have all the ideal

Despite the fact that tissue adhesives have been
available for use in humans since 1900, the tech-
nique has had limited development. This is sur-
*Corresponding author. Tel.: q44-207-467-8471; fax: q44-
1865-463432.
E-mail address: mikebowen@quista.net (M.L. Bowen).
qualities of a skin suture material w1x.
The optimal method for episiotomy and perineal
trauma repair following childbirth remains open to
debate and a great cause of concern to doctors,
midwives, and the public w2x. In a review of
published controlled trials, Grant concluded in
1989 that the best suture material was polyglycol-

0020-7292/02/$ - see front matter 䊚 2002 International Federation of Gynecology and Obstetrics. Published by Elsevier Science
Ireland Ltd. All rights reserved.
PII: S 0 0 2 0 - 7 2 9 2 Ž 0 2 . 0 0 1 4 4 - 3
202 M.L. Bowen, M. Selinger / International Journal of Gynecology and Obstetrics 78 (2002) 201–205
icypolygalactic acid (DexonyDexon II娃, Vicryl娃)
for deep and skin closure, quoting a 40% reduction
in short-term pain when compared with other
materials w3x. Isager-Sally et al. compared different
techniques of repair and found that continuous
subcuticular sutures using polyglycolic acid were
superior to other methods of skin closure w4x. This
is not unexpected when the mechanical properties
of subcuticular repairs are compared with those of
interrupted sutures. Subcuticular sutures distribute
the tension resulting from post-operative tissue
edema evenly throughout the wound and reduce
the skin pinching that can result from interrupted
sutures cutting into the skin w1x. An added benefit
is the absence of suture knots and stiffened ends
from the skin surface, which can give rise to the
‘barbed wire effect’ w2x.
Thus, the ideal material for perineal repair
should not require removal, and should give the
wound maximum elasticity (as is the case with the
subcuticular technique) with a minimal foreign
body effect. Enbucrilate tissue adhesive theoreti-
cally fulfils these requirements, in skin wounds. A
trial comparing enbucrilate tissue adhesive vs.
sutures supported this theory, concluding the result-
ing scar was cosmetically better and caused less
epidermal tissue reaction w5x.
Only one study has looked at enbucrilate in
perineal repair w6x. In 1991, Adoni and Anteby
found that enbucrilate used in episiotomy repair
reduced pain and inconvenience when compared
with 2y0 chromic catgut. Unfortunately this study
was criticized for not comparing the new method
with the ‘gold standard’ repair w3x.
A controlled trial was performed to address this
criticism. Two groups of patients were compared,
a control group (CTL), all of whom underwent
the currently acknowledged method of choice for
episiotomy repair w3,4x; and a study group (ENB0,
all of whom had the perineal skin repaired with
enbucrilate tissue adhesive.
2. Materials and methods
Ethical committee approval was obtained from
the Central Oxford Research Ethics Committee.
(COREC 2805). To minimize bias we recruited
only primiparous women experiencing a normal
delivery and requiring an episiotomy repair.
Following delivery, the women were asked by
the attending midwife if they wished to take part
in the trial and were given written information
on the study. If they consented they were allocated
to one of the two groups. One gynecologist
carried out the enbucrilate repair (Enbucrilate
Histoacryl䉸 B Braun (Medical Ltd) Brook-
dale Road, Thorncliff Park Estate Chaple-
town, Sheffield S35 2PW. Enquiries:
www.bbmuk.demon.co.uk). An attempt was made
to randomly allocate the two groups. If a physician
was not available the attending midwife carried
out the repair and the patient was allocated to the
control group. As a result, recruitment to both the
study group and the control was unpredictable.
The technique was developed at the John Rad-
cliffe Hospital, Oxford, where the trial was initi-
ated. For logistic reasons, however, it was
transferred to Northampton General Hospital. The
period of study was from September 1993 to
August 1994.
The episiotomy wound was repaired in a con-
sistent fashion according to the midwifery suture
protocol. The deep layer was repaired with a 2y0
polyglycolic acid suture (DexonyVicryl) in a con-
tinuous fashion to approximate the skin edges. The
skin edges were then repaired using a 4y0-subcu-
ticular polyglycolic acid suture (DexonyVicryl).
The same technique was employed for the study
group with the exception that the skin edges were
then glued with enbucrilate tissue adhesive. The
senior experienced midwives who were able to
suture raised the control group. The same senior
midwife repaired almost 90% of the women in this
group.
Primiparous women with mediolateral episioto-
mies were recruited. We excluded multiparous
women, those with perineal tears and those unable
to give informed consent. Women with a prenatal
history of vulvo-vaginal problems and symptoms
where subjective assessment of pain scores would
be difficult were also excluded.
3. Evaluation
All women participating were asked to complete
a daily postnatal pain score chart on days 1–5
 M.L. Bowen, M. Selinger / International Journal of Gynecology and Obstetrics 78 (2002) 201–205
Table 1
Maternal age range at delivery
Group No. Age range (years) Mean (years)"S.D.
ENB 32 17–38 26"4.2
CTL 30 18–33 26"5.4
ENB, enbucrilate; CTL, control (polyglycolicypolygalactic
sutures).
using a 1-to-10 visual analog score card in the
hospital, and to continue it at home. In addition,
the patients’ midwife reviewed the wound on a
daily basis and recorded her findings. When the
results of the first 5 days had been recorded, the
patients were asked to return the form in a
stamped, addressed envelope.
The patients were then telephoned 3–6 weeks
later by an observer blinded to the caseycontrol
status and asked to complete a second question-
naire over the telephone consisting of two ques-
tions. Those who were still experiencing pain were
then followed up until pain free.
4. Results
Most women remained in the hospital for at
least 24 h. Compliance with the study was good,
with few women refusing to take part in the study;
and of those who did, less than five were lost to
follow-up or failed to return their forms. The
midwife of the women who failed to return their
forms was asked to ensure that they were well.
Although this was so in all cases, the women were
still excluded from the study because of non-
compliance (Tables 1 and 2).
As expected, the mean daily pain scores did not
differ greatly during sedentary activities. There
was, however, a trend to lower pain scores in the
enbucrilate group but it did not achieve statistical
significance.
Using enbucrilate tissue adhesive for skin clo-
sure resulted in less pain on micturition, walking,
and defecation when compared with subcuticular
Dexon but there was no significant difference
when lying or sitting. The time taken for the
wound and for sexual intercourse to become pain
free was significantly less in the enbucrilate group.
Episiotomy repairs performed using enbucrilate
203
resulted in a 28% improvement in the time taken
to become pain free and a 35% reduction in the
onset of pain-free intercourse when compared with
sutures.
The midwives’ findings reported no wound
dehiscence or infection in either group and no
patient required the suture to be removed.
5. Discussion
Previous papers have reported favorable results
with enbucrilate for skin closure of episiotomy
wounds compared with continuous 2y0 chromic
catgut in the skin. Enbucrilate was found to be
associated with less pain when walking, sitting,
sleeping, lying down, breastfeeding, defecating,
and with micturition w6x. Isager-Sally et al. found
polyglycolic acid sutures to cause less tissue ede-
ma, inflammation, and pain than 2y0 catgut or silk
sutures. With polyglycolic acid sutures, 41% of
women experienced discomfort because the sutures
failed to dissolve by 3–6 weeks. As a result, the
sutures required removal w4x. The superiority of
polyglycolic acid sutures for deep-skin closure was
emphasized in Grant’s review of 14 controlled
trials, including the above study w3x.
Debate about the best technique for wound
closure has been addressed in a number of trials.
In Grant’s overview of the evidence in controlled
trials, continuous subcuticular suturing appeared to
be preferable to interrupted, transcutaneous sutur-
ing, particularly in terms of perineal pain in the
early puerperium. He concluded that the technique
of choice in perineal repair should be continuous
subcuticular polyglycolicypolygalactic acid sutures
but speculated that the ideal would be a synthetic
continuous subcuticular suture which could be
easily removed in the early puerperium w3x.
This study shows that episiotomy repairs per-
formed using enbucrilate have a 28% improvement
in the time taken to become pain free after delivery
and 35% improvement in the time taken to have
pain-free intercourse. Enbucrilate has inherent
advantages over subcuticular DexonyVicryl as a
skin closure material w1x. It is a butyl-cyanoacry-
late ester distinguished by a marked elasticity
caused by the long carbon hydrogen chain. Since
augmentation of the CH chain length results in
204 M.L. Bowen, M. Selinger / International Journal of Gynecology and Obstetrics 78 (2002) 201–205

Table 2
Mean pain score charts

Activity ENB CTL P-value Mann–Whitney U-test

At rest on day 1 3.2 3.7 0.432 452
At rest on day 2 2.7 3.2 0.446 356
At rest on day 3 2.4 2.6 0.65 375
At rest on day 4 1.9 2.2 0.4 351
At rest on day 5 1.7 1.8 0.736 382
Sitting on day 1 4.4 5.5 0.053 282
Sitting on day 2 4 4.9 0.066 289
Sitting on day 3 3.3 3.8 0.328 342
Sitting on day 4 2.8 3.3 0.197 323
Sitting on day 5 2.7 2.9 0.57 367
Micturition on day 1 4.5 6.3 0.025* 254
Micturition on day 2 3.5 5.1 0.0516 282
Micturition on day 3 3 4 0.025* 263
Micturition on day 4 2.4 3.5 0.078 293
Micturition on day 5 2.1 2.9 0.85 391
Walking on day 1 2.9 4.4 0.0005* 187
Walking on day 2 2.7 4 0.0015* 205
Walking on day 3 2.3 3.2 0.065 288
Walking on day 4 2.1 2.8 0.029* 267
Walking on day 5 2.4 2.2 0.1 290
Defecation on day 1 3.3 4.2 0.411 10.5
Defecation on day 2 2.5 3.2 0.276 62
Defecation on day 3 2.2 4.3 0.003* 128
Defecation on day 4 2.1 3.7 0.015* 183
Defecation on day 5 1.1 2.8 0.14 257
Mean time taken to achieve 18 25 0.0017* 209
zero pain scores
Mean time taken to achieve 34 52 0.0009* 149
pain free sex
*Statistically significant results. ENB, enbucrilate; CTL, control (polyglycolicypolygalactic sutures).

greater elasticity but at the expense of tensile
strength and increased setting time, the ideal com-
promise is achieved with butyl esters w7x.
Previous experiments have demonstrated less
tissue reaction, scar formation, and infection, espe-
cially of moist hair-bearing skin when tissue adhe-
sive is compared with sutures for skin closure
w5,7,8x. When the tissue adhesive is applied to the
skin edges as recommended, no foreign body
reaction is seen and the tissue adhesive exfoliates
spontaneously by day 5. Any tissue adhesive
absorbed is excreted in the first 14 days. Radioi-
sotope experiments found that 85% is excreted in
the urine and 8% in the feces. There is no known
risk of carcinogenesis in humans although the
product license is for topical use only w7x.
Application of the adhesive is painless and
reduces the need for local anesthetics. No keloid
formation has been reported and the scars are fine,
paler, and overall cosmetically better. The reduc-
tion in scar formation is associated with less pain
and analgesic needs w5x. The adhesive forms an
artificial scar, which is water repellent w7x and may
explain the initial immediate reduction in pain on
micturition. No significant difference is seen when
the wound is rested either sitting or lying; this,
however, is lost when the patient is walking or
defecating and the wound is subject to movement.
 M.L. Bowen, M. Selinger / International Journal of Gynecology and Obstetrics 78 (2002) 201–205
Then, the elastic properties of the tissue adhesive
become of greatest benefit.
Despite the obvious advantages in wound com-
fort, possibly due to the reduced epidermal prolif-
eration, dermal fibrosis, and absent foreign body
reaction, technical difficulties in the use of the
tissue adhesive may be encountered w8x. Optimal
healing may be influenced by epithelization and
apoptosis. Levine et al. concluded that occlusion
increased epidermal cell proliferation in wounds
(where the entire surface epithelium and papillary
dermis was removed), whereas an opposite effect
was seen in tape-stripped skin from which only
the stratum corneum had been removed w9x. Green-
halgh suggested that the mechanisms controlling
apoptosis and tissue repair might result in thera-
peutic modalities to minimize scarring w10x.
The superior outcomes with tissue adhesive
might be due to better tissue coaptation under an
occlusive film. Greenhalgh postulated that this
would cause a rapid and complete epithelization
with secondary-induced apoptosis of the underly-
ing inflammatory cells, culminating in reduced
scarring w10x.
Repair of the wound is no faster using tissue
adhesive, but like Alhopuro et al. we found the
technique simple to use w5x. The adhesive has been
applied in spray form to split skin graft donor sites
causing an immediate arrest in hemorrhage and
relief of pain. Based on these finding it may well
have a future in treating labial grazes and lacera-
tions w7x.
The study could have been improved if: a
recognized method of randomization had been
employed; more patients had been included in the
study; the same staff had been used to carry out
the repairs in both groups. In addition, validity
would be increased if: a more objective pain
assessment had been used and an independent
party had performed the telephone questionnaire.
However, this was not possible because of limited
resources and manpower. By its very nature pain
is subjective and the questionnaires were designed
along the lines of similar studies w3,6x.
205
It was assumed that patients would attempt
intercourse once pain free, and achieving pain-free
sexual intercourse was an important milestone.
There was a significant improvement in the out-
come of the patients in the tissue adhesive group,
with an earlier return to ‘normal’ and a presumed
overall increase in patient satisfaction. There are
cost implications in using tissue adhesive, howev-
er, because extra training is involved and tissue
adhesive is more expensive.
In spite of these difficulties, this pilot study
established the efficacy and superiority of tissue
adhesives over current gold standard techniques in
perineal repair. It should form the basis for further
large-scale trials.
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