Tissue adhesive for first-degree perineal tears repairing during normal delivery: a pilot randomized controlled trial

INTRODUCTION: One of the important concerns regarding the perineum is the trauma caused by the vaginal delivery and perinealrepair. The ideal perineal repair technique should be quick, painless, easy to perform in order to decrease pain in the puerperium. The scientific evidence indicates that the most suitable technique and material for the repair of perineal trauma are continuous suture and the polyglactin 910 rapid absorption thread. However, in the first and second degrees lacerations, despite promoting good healing, the suture is associated with perineum pain. The surgical adhesive is a tool used in several surgeries and medical specialties, had high resistance and is ease to manage during the surgical procedure, which seems to be an effective alternative for perineal repair. OBJECTIVE: To determine the feasibility of a clinical randomized controlled trial (RCT) on the use of surgical adhesive in the repair of first-degree perineal trauma during vaginal delivery. METHODS: Parallel, controlled and randomized pilot study comparing the outcomes of the use of surgical adhesive glue Epiglu™ (ethyl-2-cyanoacrylate) and Vicryl Rapide™ (polyglactin 910) thread in perineal repair. The research was performed at Pronto Socorro e Maternidade Zoraide Eva das Dores, Itapecerica da Serra-SP, Brazil. The sample comprised 20 women with first-degree perineal trauma that need repair during normal delivery, distributed in experimental group (EG, n=10, undergoing repair with Epiglu™) and control group (CG;n=10, undergoing repair with Vicryl Rapide™). The primary outcome was the occurrence and intensity of perineal pain after delivery and secondary outcomes were healing process, the woman’s satisfaction on perineal repair and the time spent by the professional to repair the trauma. The outcomes were evaluated by the 11-point Visual Numeric Scale for perineal pain intensity; REEDA Scale for perineal healing; Visual Analogue Scale for women’s satisfaction; digital stopwatch for counting the repair time in both suture techniques. Data were collected in four stages: up to 2 hours after delivery, 12-24 hours, 36-48 hours and 10-20 days postpartum. RESULTS: In all study stages, the average of the intensity of perineal pain among women in EG was significantly lower than CG (variation of 2.0-0.2 in EG and 2.5-0.6 in CG). In all stages, perineal healing showed significantly better REEDA scale scores among women in EG, (variation of 0.6-0.0 in EG and 1.8-0.7 in CG). The women’s satisfaction with perineal repair was significantly higher in EG (100% were satisfied or very satisfied), compared with CG (10% to 20% were unsatisfied or very unsatisfied). The average time for perineal repair was 5 minutes in EG and 21 minutes in CG (p<0.001). CONCLUSION: The results of the study were important to compare perineal repair methods and calculate the sample size for the future RCT. In addition, we showed that is possible to adopt the perineal repair technique with Epiglu™ developed in the pilot study, as well as the same outcomes and postpartum follow-up periods. PROTOCOL: The study was registered in the Brazilian Clinical Trials Registry http://www.ensaiosclinicos.gov.br/rg/RBR-2h84gt/