Antibiotic Prophylaxis in Gynecologic Laparoscopy

April 24, 2015 updated by: Fabiola Soares Moreira Campos, Universidade do Vale do Sapucai
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Pouso Alegre, Minas Gerais, Brazil, 37550-000
        • Hospital das Clinicas Samuel Libanio
      • Pouso Alegre, Minas Gerais, Brazil, 37550-000
        • Hospital e Maternidade Santa Paula

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Patients in this arm will receive intravenous sterile saline 30 minutes before the gynecologic laparoscopy.
Procedure: gynecologic laparoscopy
Gynecological laparoscopy without opening hollow viscera.
Other Names:
  • pelvic laparoscopy
  • gynecologic laparoscopic surgery
Drug: Placebo
Intravenous administration of saline sterile solution
Other Names:
  • placebo treatment
Active Comparator: Cefazolin
Patients in this arm will receive intravenous cephazolin 1g, 30 minutes before the gynecologic laparoscopy.
Procedure: gynecologic laparoscopy
Gynecological laparoscopy without opening hollow viscera.
Other Names:
  • pelvic laparoscopy
  • gynecologic laparoscopic surgery
Drug: Cefazolin
Intravenous administration of 1 g of cefazolin
Other Names:
  • Kefzol
  • Cephazolin
  • Cefazoline
  • Cephazolin Sodium for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Vale do Sapucai

Investigators

  • Principal Investigator: Fabiola SM Campos, MD, Universidade do Vale do Sapucai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

November 22, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

April 27, 2015

Last Update Submitted That Met QC Criteria

April 24, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPFabiola

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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