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Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy

NCT ID: NCT00787553

Last Updated: 2008-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hysterectomy

Keywords

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hysterectomy antibiotic prophylaxis bacterial vaginosis tinidazole cefazolin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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cefazolin

Group Type ACTIVE_COMPARATOR

cefazolin

Intervention Type DRUG

2.0 g, IV, 2 hours before surgery

tinidazole

Group Type ACTIVE_COMPARATOR

tinidazole

Intervention Type DRUG

2.0 g orally, 12 hours before surgery

cefazolin plus tinidazole

Group Type ACTIVE_COMPARATOR

cefazolin plus tinidazole

Intervention Type DRUG

cefazolin, 2.0 g IV 2 hours before surgery plus tinidazole 2.0 g orally 12 hours before surgery

Interventions

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cefazolin

2.0 g, IV, 2 hours before surgery

Intervention Type DRUG

tinidazole

2.0 g orally, 12 hours before surgery

Intervention Type DRUG

cefazolin plus tinidazole

cefazolin, 2.0 g IV 2 hours before surgery plus tinidazole 2.0 g orally 12 hours before surgery

Intervention Type DRUG

Other Intervention Names

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imidazoles cefazolin tinidazole

Eligibility Criteria

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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
Minimum Eligible Age

32 Years

Maximum Eligible Age

72 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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University of Campinas, Brazil

Principal Investigators

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Jose A Simoes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Campinas

Locations

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University of Campinas

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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920/2006

Identifier Type: -

Identifier Source: org_study_id