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Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy

Information source: University of Campinas, Brazil
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hysterectomy

Intervention: cefazolin (Drug); tinidazole (Drug); cefazolin plus tinidazole (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: University of Campinas, Brazil

Official(s) and/or principal investigator(s):
Jose A Simoes, MD, PhD, Principal Investigator, Affiliation: University of Campinas

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.

Clinical Details

Official title: Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Post-operative infection

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.

Eligibility

Minimum age: 32 Years. Maximum age: 72 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

University of Campinas, Campinas, SP 13083-970, Brazil
Additional Information

Starting date: July 2006
Last updated: November 6, 2008

Page last updated: August 23, 2015

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