Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy

November 6, 2008 updated by: University of Campinas, Brazil
Purpose: to compare the efficacy of tinidazole and cefazolin on the prophylaxis of the febrile and infectious morbidity after vaginal or abdominal hysterectomy. Methods: A randomized clinical trial carried out at the Women's Integrated Healthcare Center (CAISM)/UNICAMP, Campinas, Brazil. Women undergoing to total vaginal or abdominal hysterectomy were randomly enrolled into one of these three groups of antibiotic prophylaxis: tinidazole, cefazolin or an association of both.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A randomized clinical trial carried out at the Women's Integrated Healthcare Center (CAISM)/UNICAMP, Campinas, Brazil, to compare the efficacy of tinidazole and cefazolin on the prophylaxis of the febrile and infectious morbidity after vaginal or abdominal hysterectomy. Women undergoing to total vaginal or abdominal hysterectomy were randomly enrolled into one of these three groups of antibiotic prophylaxis: tinidazole, cefazolin or an association of both.

Study Type

Interventional

Enrollment (Actual)

75

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
    • SP
      • Campinas, SP, Brazil, 13083-970
        • University of Campinas

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

32 years to 72 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women undergoing to hysterectomy due to non-oncologic causes

Exclusion Criteria:

  • previous pelvic infection
  • antibiotic use within 7 days before surgery
  • study drugs allergy
  • immuno-incompetence
  • urinary tract infection

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: cefazolin
Drug: cefazolin
2.0 g, IV, 2 hours before surgery
ACTIVE_COMPARATOR: tinidazole
Drug: tinidazole
2.0 g orally, 12 hours before surgery
Other Names:
  • imidazoles
ACTIVE_COMPARATOR: cefazolin plus tinidazole
Drug: cefazolin plus tinidazole
cefazolin, 2.0 g IV 2 hours before surgery plus tinidazole 2.0 g orally 12 hours before surgery
Other Names:
  • cefazolin
  • tinidazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-operative infection
Time Frame: one month after surgery
one month after surgery

Collaborators and Investigators

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

Sponsor

University of Campinas, Brazil

Investigators

  • Principal Investigator: Jose A Simoes, MD, PhD, University of Campinas

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

July 1, 2006

Primary Completion (ANTICIPATED)

December 1, 2008

Study Completion (ANTICIPATED)

December 1, 2008

Study Registration Dates

First Submitted

November 6, 2008

First Submitted That Met QC Criteria

November 6, 2008

First Posted (ESTIMATE)

November 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 7, 2008

Last Update Submitted That Met QC Criteria

November 6, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 920/2006

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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