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Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy

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ClinicalTrials.gov Identifier: NCT00787553
Recruitment Status : Unknown
Verified November 2008 by University of Campinas, Brazil.
Recruitment status was:  Active, not recruiting
First Posted : November 7, 2008
Last Update Posted : November 7, 2008
Sponsor:
Information provided by:
University of Campinas, Brazil

Brief 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.

Condition or disease Intervention/treatment Phase
Hysterectomy Drug: cefazolin Drug: tinidazole Drug: cefazolin plus tinidazole Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
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
Study Start Date : July 2006
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


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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

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

Responsible Party: Jose Antonio Simoes, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT00787553     History of Changes
Other Study ID Numbers: 920/2006
First Posted: November 7, 2008    Key Record Dates
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