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Episiotomy closure comparing enbucrilate tissue adhesive with conventional sutures
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 Despite the fact that tissue adhesives have been available for use in humans since 1900, the technique has had limited development. This is sur*Corresponding author. Tel.: q44-207-467-8471; fax: q441865-463432. E-mail address: [email protected] (M.L. Bowen).
prising given that adhesives have all the ideal 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 theoretically fulfils these requirements, in skin wounds. A trial comparing enbucrilate tissue adhesive vs. sutures supported this theory, concluding the resulting 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) Brookdale Road, Thorncliff Park Estate Chapletown, 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 Radcliffe Hospital, Oxford, where the trial was initiated. 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 consistent fashion according to the midwifery suture protocol. The deep layer was repaired with a 2y0 polyglycolic acid suture (DexonyVicryl) in a continuous fashion to approximate the skin edges. The skin edges were then repaired using a 4y0-subcuticular 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 episiotomies 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 CTL
32 30
17–38 18–33
26"4.2 26"5.4
ENB, enbucrilate; CTL, control (polyglycolicypolygalactic sutures).
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
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 questionnaire over the telephone consisting of two questions. 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 noncompliance (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 closure 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
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 edema, 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 suturing, 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 performed 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-cyanoacrylate ester distinguished by a marked elasticity caused by the long carbon hydrogen chain. Since augmentation of the CH chain length results in
M.L. Bowen, M. Selinger / International Journal of Gynecology and Obstetrics 78 (2002) 201–205
204
Table 2 Mean pain score charts Activity At At At At At
ENB
CTL
P-value
Mann–Whitney U-test
rest rest rest rest rest
on on on on on
day day day day day
1 2 3 4 5
3.2 2.7 2.4 1.9 1.7
3.7 3.2 2.6 2.2 1.8
0.432 0.446 0.65 0.4 0.736
452 356 375 351 382
Sitting Sitting Sitting Sitting Sitting
on on on on on
day day day day day
1 2 3 4 5
4.4 4 3.3 2.8 2.7
5.5 4.9 3.8 3.3 2.9
0.053 0.066 0.328 0.197 0.57
282 289 342 323 367
4.5 3.5 3 2.4 2.1
6.3 5.1 4 3.5 2.9
0.025* 0.0516 0.025* 0.078 0.85
254 282 263 293 391
2.9 2.7 2.3 2.1 2.4
4.4 4 3.2 2.8 2.2
0.0005* 0.0015* 0.065 0.029* 0.1
187 205 288 267 290
3.3 2.5 2.2 2.1 1.1
4.2 3.2 4.3 3.7 2.8
0.411 0.276 0.003* 0.015* 0.14
10.5 62 128 183 257
Micturition Micturition Micturition Micturition Micturition
on on on on on
Walking Walking Walking Walking Walking
day day day day day
on on on on on
Defecation Defecation Defecation Defecation Defecation
on on on on on
day day day day day
1 2 3 4 5
1 2 3 4 5
day day day day day
1 2 3 4 5
Mean time taken to achieve zero pain scores Mean time taken to achieve pain free sex
18
25
0.0017*
209
34
52
0.0009*
149
*Statistically significant results. ENB, enbucrilate; CTL, control (polyglycolicypolygalactic sutures).
greater elasticity but at the expense of tensile strength and increased setting time, the ideal compromise is achieved with butyl esters w7x. Previous experiments have demonstrated less tissue reaction, scar formation, and infection, especially of moist hair-bearing skin when tissue adhesive 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. Radioisotope 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 reduction 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 comfort, possibly due to the reduced epidermal proliferation, 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. Greenhalgh suggested that the mechanisms controlling apoptosis and tissue repair might result in therapeutic 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 underlying 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 lacerations 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 outcome 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, however, 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. References w1x Forrester JC. Suture materials and their use. Br J Hosp Med 1972;11:578 –592. w2x Rix J. A painful and perineal problem. The Daily Telegraph, September 29, 1992. w3x Grant A. The choice of suture materials and techniques for repair of perineal trauma: an over-view of the evidence from controlled trials. Br J Obstet Gynaecol 1989;96:1281 –1289. w4x Isager-Sally L, Legarth J, Jacobsen B, Bustofte E. Episiotomy repair—immediate and long-term sequelae. A prospective randomised study of three different methods of repair. Br J Obstet Gynaecol 1986;93:420 –425. w5x Alhopuro S, Rintala A, Salo H, Ritsila¨ H. Tissue adhesive vs. sutures closure of incision wounds. A comparative study in human skin. Ann Chirurg Gynaecol 1976;65:308 –312. w6x Adoni A, Anteby E. The use of Histoacryl for episiotomy repair. Br J Obstet Gynaecol 1991;98:476 –478. w7x Heiss WH. The use of synthetic polymeric materials as ´ suture substitutes. In: Rickham PP, Hecker WCh, Prevot J, editors. Munich: Urban & Schwarzenberg, 1970. p. 99 –145. w8x Galil KA, Schofield ID, Wright GZ. Scientific effect of N-butyl-2-cyanoacrylate (Histoacryl blue) on the healing of skin wounds. J Can Dent Assoc 1984;7:565 – 569. w9x Greenhalgh DG. The role of apoptosis in wound healing. Int J Biochem Cell Biol 1998;30:1019 –1030. w10x Levine R, Agren MS, Mertz PM. Effect of occlusion on cell proliferation during epidermal healing. J Cutan Med Surg 1998;2:193 –198.
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 Despite the fact that tissue adhesives have been available for use in humans since 1900, the technique has had limited development. This is sur*Corresponding author. Tel.: q44-207-467-8471; fax: q441865-463432. E-mail address: [email protected] (M.L. Bowen).
prising given that adhesives have all the ideal 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 theoretically fulfils these requirements, in skin wounds. A trial comparing enbucrilate tissue adhesive vs. sutures supported this theory, concluding the resulting 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) Brookdale Road, Thorncliff Park Estate Chapletown, 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 Radcliffe Hospital, Oxford, where the trial was initiated. 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 consistent fashion according to the midwifery suture protocol. The deep layer was repaired with a 2y0 polyglycolic acid suture (DexonyVicryl) in a continuous fashion to approximate the skin edges. The skin edges were then repaired using a 4y0-subcuticular 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 episiotomies 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 CTL
32 30
17–38 18–33
26"4.2 26"5.4
ENB, enbucrilate; CTL, control (polyglycolicypolygalactic sutures).
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
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 questionnaire over the telephone consisting of two questions. 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 noncompliance (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 closure 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
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 edema, 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 suturing, 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 performed 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-cyanoacrylate ester distinguished by a marked elasticity caused by the long carbon hydrogen chain. Since augmentation of the CH chain length results in
M.L. Bowen, M. Selinger / International Journal of Gynecology and Obstetrics 78 (2002) 201–205
204
Table 2 Mean pain score charts Activity At At At At At
ENB
CTL
P-value
Mann–Whitney U-test
rest rest rest rest rest
on on on on on
day day day day day
1 2 3 4 5
3.2 2.7 2.4 1.9 1.7
3.7 3.2 2.6 2.2 1.8
0.432 0.446 0.65 0.4 0.736
452 356 375 351 382
Sitting Sitting Sitting Sitting Sitting
on on on on on
day day day day day
1 2 3 4 5
4.4 4 3.3 2.8 2.7
5.5 4.9 3.8 3.3 2.9
0.053 0.066 0.328 0.197 0.57
282 289 342 323 367
4.5 3.5 3 2.4 2.1
6.3 5.1 4 3.5 2.9
0.025* 0.0516 0.025* 0.078 0.85
254 282 263 293 391
2.9 2.7 2.3 2.1 2.4
4.4 4 3.2 2.8 2.2
0.0005* 0.0015* 0.065 0.029* 0.1
187 205 288 267 290
3.3 2.5 2.2 2.1 1.1
4.2 3.2 4.3 3.7 2.8
0.411 0.276 0.003* 0.015* 0.14
10.5 62 128 183 257
Micturition Micturition Micturition Micturition Micturition
on on on on on
Walking Walking Walking Walking Walking
day day day day day
on on on on on
Defecation Defecation Defecation Defecation Defecation
on on on on on
day day day day day
1 2 3 4 5
1 2 3 4 5
day day day day day
1 2 3 4 5
Mean time taken to achieve zero pain scores Mean time taken to achieve pain free sex
18
25
0.0017*
209
34
52
0.0009*
149
*Statistically significant results. ENB, enbucrilate; CTL, control (polyglycolicypolygalactic sutures).
greater elasticity but at the expense of tensile strength and increased setting time, the ideal compromise is achieved with butyl esters w7x. Previous experiments have demonstrated less tissue reaction, scar formation, and infection, especially of moist hair-bearing skin when tissue adhesive 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. Radioisotope 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 reduction 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 comfort, possibly due to the reduced epidermal proliferation, 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. Greenhalgh suggested that the mechanisms controlling apoptosis and tissue repair might result in therapeutic 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 underlying 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 lacerations 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.
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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 outcome 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, however, 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. References w1x Forrester JC. Suture materials and their use. Br J Hosp Med 1972;11:578 –592. w2x Rix J. A painful and perineal problem. The Daily Telegraph, September 29, 1992. w3x Grant A. The choice of suture materials and techniques for repair of perineal trauma: an over-view of the evidence from controlled trials. Br J Obstet Gynaecol 1989;96:1281 –1289. w4x Isager-Sally L, Legarth J, Jacobsen B, Bustofte E. Episiotomy repair—immediate and long-term sequelae. A prospective randomised study of three different methods of repair. Br J Obstet Gynaecol 1986;93:420 –425. w5x Alhopuro S, Rintala A, Salo H, Ritsila¨ H. Tissue adhesive vs. sutures closure of incision wounds. A comparative study in human skin. Ann Chirurg Gynaecol 1976;65:308 –312. w6x Adoni A, Anteby E. The use of Histoacryl for episiotomy repair. Br J Obstet Gynaecol 1991;98:476 –478. w7x Heiss WH. The use of synthetic polymeric materials as ´ suture substitutes. In: Rickham PP, Hecker WCh, Prevot J, editors. Munich: Urban & Schwarzenberg, 1970. p. 99 –145. w8x Galil KA, Schofield ID, Wright GZ. Scientific effect of N-butyl-2-cyanoacrylate (Histoacryl blue) on the healing of skin wounds. J Can Dent Assoc 1984;7:565 – 569. w9x Greenhalgh DG. The role of apoptosis in wound healing. Int J Biochem Cell Biol 1998;30:1019 –1030. w10x Levine R, Agren MS, Mertz PM. Effect of occlusion on cell proliferation during epidermal healing. J Cutan Med Surg 1998;2:193 –198.