CLINICAL TRIAL ON THE USE OF GLUE SURGICAL TO REPAIR EPISIOTOMIES AND PERINEAL LACERATIONS

• Grant number: 15/15162-1
• Support Opportunities: Regular Research Grants
• Duration: October 01, 2016 - September 30, 2018
• Field of knowledge: Health Sciences - Nursing - Obstetrical Nursing
• Principal Investigator: Adriana Caroci Becker
• Grantee: Adriana Caroci Becker
• Host Institution: Escola de Artes, Ciências e Humanidades (EACH). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Associated researchers: Maria Luiza Gonzalez Riesco

Abstract

Introduction: The use of adhesives glue should be studied for perineal repair in normal delivery, because it is already widely used in various fields of medicine and can bring benefits to the woman. Objective: To evaluate the effectiveness of adhesive glue in repairing episiotomy and second degree perineal tears in normal birth and 8 months postpartum; Method: randomized controlled trial comparing the use of adhesive glue GLUBRAN-2® using suture with Vicryl® quickly absorbed in perineal repair in normal birth, in 70 women that will undergo episiotomy or who had spontaneous perineal lacerations of second degree, in the city of Itapecerica da Serra, São Paulo. The sample consists in order to detect a significant minimum difference of 2 points in pain scores between the three methods of perineal repair. To do so will be considered, a priori, a residual standard deviation of 3 points, alpha error of 5% and power of 80%, resulting in a minimum sample of 35 pregnant women in each group. Data will be collected in 6 different steps between the months August 2016 to July 2017. The project was approved by the Ethics Committee of the School of Arts, Sciences and Humanities of the University of Sao Paul. Expected results: Whereas the study results are similar to studies about the use of adhesives glues as suture replacements in various surgeries, is expected to show that this method is also feasible for the perineum repair, bringing benefits to women as decrease the occurrence and intensity of perineal pain and discomfort compared to suture technique wired, less perineal infection rate in the postpartum, more practical and less time performing the procedure for professionals who attend childbirth and greater satisfaction woman. (AU)