Skin Glues Compared to Running Sutures for Perineal Skin Repair After Vaginal Delivery. A Randomized Controlled Trial

Trial design: Randomized controlled trial. Objectives: To examine the effect of adhesive glue compared to fast‐absorbable running sutures on pain sensation following repairing perineal skin in cases of tears grade 1 and 2. Trial population: Women delivering vaginally at Emek Medical Center, and experience a spontaneous perineal tear, grade 1 or 2, or episiotomy. Trial course: Eligible patients will be asked to participate in this trial before perineal tear repair. Following providing an explanation about the trial, patients will be asked to provide written informed consent to participate in the trial. The patients will be randomly assigned to one of the two groups in a 1:1 ratio: 1. Suturing the perineal skin of the perineum using fast‐absorbable running sutures (Vicryl Rapide 3‐0) 2. Closing the perineal skin using adhesive glue‐ exofin® (Octyl‐2‐cyanoacrylate). Other than skin closure, both groups will be treated similarly according to standard protocol used for perineal tear repair. Sample size In order to detect a reduction of 20% in the VAS (visual analogue pain score) within 2 hours of the procedure between the groups [from 40% to 20% in the running sutures and glue groups, respectively) with a level of significance of 95% (α = 0.05 ‐ two tailed) and a power of 80% (β = 0.2) a sample size of 182 women (91 per group) is needed. Data collected during the study: ‐ Data collected during the repair of the tear: maternal age, ethnicity, pre‐gestational body mass index, background medical conditions, medication use, smoking status, birth's number, number of vaginal/caesarean births in the past, perineal tears in the past, antenatal complications, gestational age at delivery, epidural use during labor, birth weight, gender, grade of tear, spontaneous or episiotomy, cross over (failure of completing the procedure with the assigned method), number of skin sutures/glue capsules that was used, length of the perineal incision, repair time, use of local analgesics during repair, pain sensation related to the procedure. Pain sensation will be evaluated within 2 hours using a 0 (no pain) to 100 Visual Analogue Scale (VAS). Additionally immediate breastfeeding will be assessed as well. ‐ Data collected 48 hours after the repair and prior to discharge: pain level during walking/standing/sitting/lying down, (pain will be evaluated using the same VAS), discomfort during walking/standing/sitting/lying down, difficulty and pain in urination, local edema, local infection, separation of the edges of the wound, need for re‐suturing, need to remove a stitch, woman's satisfaction and breastfeeding. ‐ Data collected 4‐6 weeks after repair: women will be asked to return for check‐up visit by a physician that was not involved in the repair and unaware of the allocation group. The outcomes that will be assessed at this visit will include: pain during walking/standing/sitting/lying, discomfort during walking/standing/sitting/lying down, difficulty and pain in urination, time to return to sexual activity, dyspareunia, cosmetic result, skin dehiscence and granuloma, preference of women for the next delivery. A telephone questionnaire will be used to collect the same data among women who do not attend the clinic visit within 6 weeks.