The use of non-surgical glue to repair perineal first-degree lacerations in normal birth: A non-inferiority randomised trial.
Women Birth
; 34(5): e514-e519, 2021 Sep.
Article
em En
| MEDLINE
| ID: mdl-33071207
ABSTRACT
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 >3mm. 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), 24-48h (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).Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Lacerações
Tipo de estudo:
Clinical_trials
/
Observational_studies
/
Risk_factors_studies
Limite:
Female
/
Humans
/
Pregnancy
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article