Comparative study of surgical site infection with or without post cesarean prophylactic oral antibiotics; a single-blinded randomized clinical trial

Abstract

Introduction: Surgical site infection (SSI) is caused by cesarean section in the hospital and its prevalence in the studies is up to 16%. Objectives: This study aimed to compare the rate of infection in women undergoing cesarean section. Oral clindamycin and cefalexin were administered for 48 hours as prophylactic antibiotics. Patients and Methods: In this clinical trial study, women with emergency cesarean section were divided into two groups. Intervention was oral administration of cefalexin 500mg every 6 hours and clindamycin 300 mg every 6 hours for 48 hours. All participants were referred to the gynecology center on day 7–10, at the time of removal of the sutures, and within 30 days after cesarean section, to assess the presence or absence of wound infection after surgery during 30 days. Results: In this clinical trial study, 462 pregnant women undergoing cesarean section were enrolled in the intervention and control groups. Of 231 patients in the intervention group, 15 women (6.5%) had cesarean section infection (13 cases with superficial, and 2 cases with deep infection). In the control group, 45 cases (19.5%) had cesarean section infection (31 cases with superficial, 10 cases with deep, and 4 cases with developed pelvic infection) (P = 0.001). Age, pre-cesarean length of stay, pre-term incision, type of incision, discharge longer than 18 hours after cesarean section, and maternal diabetes were significantly different regarding cesarean section infection in both groups. The frequency of cesarean section infection was less in the intervention group (P <0.001). Conclusion: Administration of prophylactic antibiotic can have a significant role in reducing cesarean section infection. Trial Registration: Registration of trial protocol has been approved in Thailand registry of clinical trials (identifier: TCTR20201204002, http://www.clinicaltrials.in.th/index.php?tp=regtrials & menu=trialsearch & s-menu=fulltext & task=search & task2=view1 & id=7120, ethical code; IR.UMSU.REC.1397.323).