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Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by University of Campinas, Brazil.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00787553
First Posted: November 7, 2008
Last Update Posted: November 7, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Campinas, Brazil
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Post-operative infection [ Time Frame: one month after surgery ]

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
Active Comparator: tinidazole Drug: tinidazole
2.0 g orally, 12 hours before surgery
Other Name: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   32 Years to 72 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jose Antonio Simoes, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT00787553     History of Changes
Other Study ID Numbers: 920/2006
First Submitted: November 6, 2008
First Posted: November 7, 2008
Last Update Posted: November 7, 2008
Last Verified: November 2008

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

Additional relevant MeSH terms:
Anti-Bacterial Agents
Cefazolin
Antibiotics, Antitubercular
Tinidazole
Anti-Infective Agents
Antitubercular Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents