Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy

Hysterectomy Clinical Trial

Official title:

Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00787553
• Other study ID #: 920/2006
• Status: Active, not recruiting
• Phase: N/A
• First received: November 6, 2008
• Last updated: November 6, 2008
• Start date: July 2006
• Est. completion date: December 2008

Study information

• Verified date: November 2008
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 32 Years to 72 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hysterectomy

Intervention

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

Locations

Country	Name	City	State
Brazil	University of Campinas	Campinas	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative infection		one month after surgery	No