Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy

University of Campinas, Brazil

Status: Unknown

Conditions: Hysterectomy

Treatments: Drug: cefazolin; Drug: tinidazole; Drug: cefazolin plus tinidazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00787553

920/2006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: Female

Ages: 32 to 72 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

cefazolin

Active Comparator group

Treatment:

Drug: cefazolin

tinidazole

Active Comparator group

Treatment:

Drug: tinidazole

cefazolin plus tinidazole

Active Comparator group

Treatment:

Drug: cefazolin plus tinidazole