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Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by University of Campinas, Brazil.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT00787553
First received: November 6, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Hysterectomy
 Drug: cefazolin
Drug: tinidazole
Drug: cefazolin plus tinidazole

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Post-operative infection [ Time Frame: one month after surgery ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: July 2006
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cefazolin Drug: cefazolin
2.0 g, IV, 2 hours before surgery
Other Name: cefazolin
Active Comparator: tinidazole Drug: tinidazole
2.0 g orally, 12 hours before surgery
Other Names:
  • tinidazole
  • 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

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

Ages Eligible for Study:   32 Years to 72 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787553

Locations
Brazil
University of Campinas
Campinas, SP, Brazil, 13083-970
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Principal Investigator: Jose A Simoes, MD, PhD University of Campinas
  More Information

No publications provided

Responsible Party: Jose Antonio Simoes, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT00787553     History of Changes
Other Study ID Numbers: 920/2006
Study First Received: November 6, 2008
Last Updated: November 6, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
hysterectomy
antibiotic prophylaxis
bacterial vaginosis
tinidazole
cefazolin

Additional relevant MeSH terms:
Anti-Bacterial Agents
Cefazolin
Tinidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on June 18, 2013