Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 6, 2008
CompletedFirst Posted
Study publicly available on registry
November 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedNovember 7, 2008
November 1, 2008
2.4 years
November 6, 2008
November 6, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-operative infection
one month after surgery
Study Arms (3)
cefazolin
ACTIVE COMPARATORtinidazole
ACTIVE COMPARATORcefazolin plus tinidazole
ACTIVE COMPARATORInterventions
cefazolin, 2.0 g IV 2 hours before surgery plus tinidazole 2.0 g orally 12 hours before surgery
Eligibility Criteria
You may qualify if:
- women undergoing to hysterectomy due to non-oncologic causes
You may not qualify if:
- previous pelvic infection
- antibiotic use within 7 days before surgery
- study drugs allergy
- immuno-incompetence
- urinary tract infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Campinas
Campinas, São Paulo, 13083-970, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose A Simoes, MD, PhD
University of Campinas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 6, 2008
First Posted
November 7, 2008
Study Start
July 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
November 7, 2008
Record last verified: 2008-11