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OpenTrials
Completed

NCT Number: NCT01991834

Antibiotic Prophylaxis in Gynecologic Laparoscopy

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.

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Key information

Conditions

Infection Secondary to Surgical Procedure Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clinicas Samuel Libanio, Pouso Alegre, Minas Gerais, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gynecologic laparoscopy

Procedure

Gynecological laparoscopy without opening hollow viscera.

Other names: pelvic laparoscopy, gynecologic laparoscopic surgery

Cefazolin

Drug

Intravenous administration of 1 g of cefazolin

Other names: Cephazolin, Cefazoline, Cephazolin Sodium for Injection, Kefzol

Placebo

Drug

Intravenous administration of saline sterile solution

Other names: placebo treatment

Primary outcomes

  1. Surgical site infection

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidade do Vale do Sapucai

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2013
Registry last updated
Apr 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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