Women and birth : journal of the Australian College of Midwives · 2020
The use of non-surgical glue to repair perineal first-degree lacerations in normal birth: A non-inferiority randomised trial.
СтатьяРандомизированное исследованиеEquivalence TrialНазвание и аннотация: Перевод в очереди
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Ochiai A M, Araújo N M, Moraes S D T A, Caroci-Becker A, Sparvoli L G, Teixeira T T, Carvalho R R
Аннотация
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).
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).