CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 18 enrolled
Drug / intervention
Cefazolin PostOperatively +1 moredrug
Likely dose
Cefazolin PostOperatively 900 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00550290
NCT00550290Phase 4Completed

Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy

Aultman Health Foundation·interventional·Posted Oct 29, 2007·Updated Oct 17, 2018

In Brief

A Phase 4 clinical trial evaluating Cefazolin PostOperatively and Cefazolin Preoperatively for Wound Infection. Completed, enrolled 18 participants across 1 site.

Detailed Summary

This randomized prospective study will specifically investigate the efficacy of a 24 hour post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in preventing wound infection and wound breakdown following vulvectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWound Infection
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 29, 2007
Enrollment StartOct 1, 2007
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.7 years ago

Interventions

Cefazolin PostOperativelydrug

Cefazolin 1 gram IV every 8 hours for a total of 3 doses. Patients in both arms will receive an initial pre-operative 2 gram dose of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV q 8 hrs will be used.

Cefazolin Preoperativelydrug

Patients in active comparator arm will receive an initial pre-operative 2 gram does of Cefazolin within 30 minutes prior to incision. In penicillin/cephalosporin allergic patients, the substitute of Clindamycin 900 mg IV will be used.