Tissue adhesive to repair first-degree perineal tear: a pilot randomized controlled trial

Abstract

Tissue adhesive to repair first-degree perineal tear: a pilot randomized controlled trial T. Trevisan Teixeira1, A. de S. Caroci2, W. Sousa Brunelli3, M. L. Riesco4 1School of Nursing, University of São Paulo. Midwife in clinical practice at Casa Angela Birth Center (Brazil) 2School of Arts, Sciences and Humanities, University of São Paulo (Brazil) 3School of Nursing, University of São Paulo (Brazil) 4School of Nursing, University of São Paulo (Brazil) Summary Purpose of Investigation: This pilot study proposes to verify the feasibility of conducting a randomized controlled trial (RCT) on the use of Epiglu tissue adhesive to repair first-degree tear. Materials and Methods: A pilot RCT was conducted in a birth center in São Paulo, Brazil. The sample consisted of 20 women with first-degree tear. These women were randomly assigned to the experimental group (EG=10) - perineal tear repair with Epiglu or the control group (CG=10) - perineal tear repair with absorbable synthetic thread. The measured outcomes were perineal pain, perineal healing, women’s satisfaction, and professional’s time spent repairing the perineum. Results: The intensity of perineal pain was significantly lower among women in the EG than that in the CG in all stages of the study (EG range: 2.0-0.2; CG range: 2.5-0.6). Additionally, perineal healing showed significantly better REEDA scores among women in the EG than those in the CG in all stages (EG range: 0.6-0.0; CG range: 1.8-0.7). Women’s satisfaction was significantly higher in the EG (100% were satisfied or very satisfied) than that in the CG (10% to 20% of them were dissatisfied or very dissatisfied). The mean time spent to repair the perineum was five minutes in the EG and 21 minutes in the CG (p < 0.001). Conclusion: This study shows that it is feasible to undertake an RCT on the use of the tissue adhesive Epiglu for first-degree perineal tear repair during normal birth. Key Words: Natural childbirth; Perineum; Lacerations; Tissue adhesives; Cyanoacrylates; Wound healing.