The Use of Non-Surgical Glue to Repair Perineal First-Degree Lacerations in Normal Birth: A Non-Inferiority Randomised Trial

Background and problem: Surgical glue has been indicated for uncomplicated operatory wounds; however, it has a considerable cost. Non-surgical glue, a commercially available and cheaper product, has not been studied for repairing postpartum lacerations. Aim: To compare non-surgical glue to traditional sutures on perineal first-degree lacerations after normal birth. Methods: In a prospective, open-label, non-inferiority, randomised controlled trial, we selected childbearing women who were admitted for normal term births and in whom skin lacerations occurred. They were assigned to laceration repair using either non-surgical glue (ethyl 2-cyanoacrylate; Glue group) or catgut sutures (Suture group). The primary endpoint was the occurrence of dehiscence >3 mm. Secondary endpoints were procedure runtime, pain score, satisfaction level, and aspects of perineal repair by the REEDA score (hyperaemia, oedema, ecchymosis, exudation, and coaptation) immediately (T0), 24-48 h (T1), and 7-10 days (T2) after childbirth. Findings: We included 126 women, 63 in each group, and found a non-inferiority dehiscence rate in the Glue Group compared to the Control group (T1 = 1.6% vs. 1.6%, P = 0.999 and P < 0.001 for non-inferiority; and T2 = 2.2% vs. 4.3%, P = 0.557). In the Glue Group, the procedure runtime was shorter, pain score was lower, and women's satisfaction was greater. No women had any allergic reaction in the study. Conclusions: Non-surgical glue was not inferior to traditional sutures to repair postpartum first-degree lacerations. In addition, non-surgical glue was associated with less pain and greater satisfaction. Brazilian Clinical Trials Registry (www.ensaiosclinicos.gov.br/rg/RBR-5Z8MKC). (c) 2020 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.