Clinically relevant wound complications occurred in 9% of patients receiving antibiotics compared with 17% receiving placebo, according to a recent study.
In the single-center, double-blind, placebo-controlled randomized REPAIR trial conducted at Herlev Hospital in Denmark, researchers found that prophylactic oral amoxicillin with clavulanic acid reduced clinically relevant wound complications following episiotomy or second-degree perineal tear. Overall wound complication rates were similar between the groups, whereas exploratory analyses indicated that the antibiotic group had fewer unplanned consultations and fewer additional antibiotic treatments.
The researchers enrolled 442 postpartum patients between March and December 2023. The participants were Danish-speaking, at least 18 years old, and had a second-degree tear or mediolateral episiotomy requiring suturing. Exclusion criteria included treatment allergy, recent antibiotic use, cesarean birth, and episiotomy extension. Within 6 hours of delivery, the participants were randomly assigned to receive three doses of amoxicillin, 500 mg, with clavulanic acid, 125 mg, or matching placebo, administered at 8-hour intervals. Follow-up occurred 4 to 14 days postpartum, and 433 patients completed the initial consultation.
The study’s primary outcome was wound complication, defined as infection or dehiscence greater than 5 mm on clinical examination. A secondary outcome, clinically relevant wound complication, included larger dehiscence (typically at least 10 mm), substantial pain, patient-reported affected daily life, or infection warranting clinical follow-up. Standardized clinical assessments were performed in the lithotomy position, and questionnaire data were used to corroborate symptoms and treatment-related factors.
Among the 433 patients evaluated, 25% (n = 109) of them had wound complications. Although the overall complication rates were similar between the groups, subgroup and sensitivity analyses showed lower rates of clinically relevant wound complications in the antibiotic group, including among patients without higher-risk factors such as body mass index of at least 30, instrumental delivery, or episiotomy. No serious adverse events occurred, and adverse events were similar between both groups.
The outcome of clinically relevant wound dehiscence was entered into ClinicalTrials.gov after trial initiation, even though it had been defined beforehand and evaluated throughout the study. Generalizability may be limited by the single-center setting, restriction to Danish-speaking participants, lack of ethnicity data, and exclusion of those who received intrapartum antibiotics, along with potential differences in pathogens, resistance patterns, and obstetric practices.
“This finding supports the use of prophylactic antibiotics in routine clinical practice after a second degree tear or episiotomy,” noted lead study author Kathrine Perslev, a doctoral student in the Department of Gynaecology and Obstetrics at the Herlev Hospital in Denmark and the Faculty of Health and Medical Sciences at the University of Copenhagen, and colleagues.
The researchers reported no competing financial interests.
Source: The BMJ