Antibiotic Prophylaxis in Gynecologic Laparoscopy

Not Applicable

Completed

• Conditions: Infection Secondary to Surgical Procedure
• Interventions: Procedure: gynecologic laparoscopy; Drug: Placebo; Drug: Cefazolin

• Registration Number: NCT01991834
• Lead Sponsor: Universidade do Vale do Sapucai

Brief Summary

Laparoscopy is a surgical procedure indicated for most gynecological pathologies and presents numerous advantages over laparotomy, among them lower rates of surgical site infection and less comorbidity feverish. Despite this, the use of antibiotic prophylaxis is widely accepted and performed by most gynecologists. However, there isn't literature evidence to support the routine use of antibiotics in the prophylaxis of wound infection on laparoscopic pelvic surgery .Therefore, this study will evaluate the need for the use of antibiotic prophylaxis in gynecological laparoscopies not including opening hollow viscera.

Detailed Description

It is a clinical, prospective, double-blind, randomized study. 114 women with gynecologic disease, in which there is indication of laparoscopic surgical approach, will be consecutively select. These women will be allocated in two arms, control and study, where control group will use placebo and study will receive intravenous cephazolin. These patients will be followed for 30 days according to Centers for Disease Control and Prevention criteria.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-25
• Primary Completion: 2015-03
• Status Verified: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-24
• Last Update Posted: 2015-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

Inclusion Criteria

• patients with gynecologic disease, undergoing gynecologic laparoscopy without opening hollow viscera.

Exclusion Criteria

• body mass index over 30 Kg/m2
• smoking
• diabetes type I or II with glycated hemoglobin exceeding 6.5%
• patients who are at surgical risk classification of the American Society of Anesthesiologists(ASA) as ASA III or higher
• refusal to participate
• postoperative antibiotic therapy for another indication clinical complication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	gynecologic laparoscopy	Patients in this arm will receive intravenous sterile saline 30 minutes before the gynecologic laparoscopy.
Placebo	Placebo	Patients in this arm will receive intravenous sterile saline 30 minutes before the gynecologic laparoscopy.
Cefazolin	gynecologic laparoscopy	Patients in this arm will receive intravenous cephazolin 1g, 30 minutes before the gynecologic laparoscopy.
Cefazolin	Cefazolin	Patients in this arm will receive intravenous cephazolin 1g, 30 minutes before the gynecologic laparoscopy.

Primary Outcome Measures

Name	Time	Method
Surgical site infection	30 days	Patients are followed weekly by a masked surgeon in regard to surgical site infecton (SSI), until the 30th postoperative day. Centers for Disease Control and Prevention's (CDC) criteria and classification were adopted.

Trial Locations

Locations (2)

Hospital das Clinicas Samuel Libanio; 🇧🇷 Pouso Alegre, Minas Gerais, Brazil

Hospital e Maternidade Santa Paula; 🇧🇷 Pouso Alegre, Minas Gerais, Brazil