Journal of Clinical Trials
Open Access

Abstract

Antibiotic Prophylaxis in Gynecologic Laparoscopy: Study Protocol for a Randomized Controlled Trial

Fabíola Soares Moreira Campos, Silvania de Cassia Vieira Archangelo, Antônio Marcos Coldibelli Francisco, Rodrigo Pedro Fausto de Lima, Yara Juliano, Lydia Masako Ferreira and Daniela Francescato Veiga

Background: Laparoscopy is a surgical procedure indicated for most gynecological pathologies. It presents numerous advantages over laparotomy; among these are lower rates of surgical site infection and less febrile comorbidity. Despite this, the use of antibiotic prophylaxis is widely accepted and performed by most gynecologists. However, no evidence exists in the literature to support the routine use of antibiotics in the prophylaxis of wound infection in laparoscopic pelvic surgery.
Objective: This study aims to assess the surgical site infection rates for gynecological laparoscopies, not involving the opening of hollow viscera, among patients receiving or not antibiotic prophylaxis.
Methods: This is a clinical, prospective, double-blind, randomized study. A total of 216 women with gynecological pathologies, undergoing laparoscopic surgical approach, will be consecutively selected. The patients will be randomly allocated to either the placebo group (n=108), to receive 10 mL of intravenous sterile saline, or to the antibiotic group (n=108), to receive 1 g of intravenous cefazolin 30 minutes before the surgery. To evaluate the incidence of surgical site infection, criteria of the Centers for Disease Control and Prevention (CDC) will be used. The patients will be evaluated weekly for 30 days.
Discussion: The CDC “Guideline for Prevention of Surgical Site Infection” provides recommendations for the prevention of surgical site infections. However, for some practices, no recommendations are offered, due to a lack of consensus or insufficient evidence on the effectiveness of preventative measures. Interventions to reduce the incidence of surgical site infections are essential to reduce not only morbidity, but also costs to patients and society.
Trial registration: ClinicalTrials.gov identifier: NCT01991834.