Overview

This trial is active, not recruiting.

Condition hysterectomy
Treatments cefazolin, tinidazole, cefazolin plus tinidazole
Sponsor University of Campinas, Brazil
Start date July 2006
End date December 2008
Trial size 75 participants
Trial identifier NCT00787553, 920/2006

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
cefazolin cefazolin
2.0 g, IV, 2 hours before surgery
(Active Comparator)
tinidazole tinidazole
2.0 g orally, 12 hours before surgery
(Active Comparator)
cefazolin plus tinidazole cefazolin
cefazolin, 2.0 g IV 2 hours before surgery plus tinidazole 2.0 g orally 12 hours before surgery

Primary Outcomes

Measure
Post-operative infection
time frame: one month after surgery

Eligibility Criteria

Female participants from 32 years up to 72 years old.

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

Additional Information

Official title Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy
Principal investigator Jose A Simoes, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2008.
Information provided to ClinicalTrials.gov by University of Campinas, Brazil.