NCT01991834

Antibiotic Prophylaxis in Gynecologic Laparoscopy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Universidade do Vale do Sapucai · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infection Secondary to Surgical Procedure

Interventions

Type	Name	Description
PROCEDURE	gynecologic laparoscopy	Gynecological laparoscopy without opening hollow viscera.
DRUG	Cefazolin	Intravenous administration of 1 g of cefazolin
DRUG	Placebo	Intravenous administration of saline sterile solution

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-03-01
• Completion: 2015-04-01
• First posted: 2013-11-25
• Last updated: 2015-04-27

Locations

2 sites across 1 country: Brazil