At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
Cefazolindrug
Likely dose
Not stated in 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.
Does Antibiotic Prophylaxis Reduce Wound Complications After Vulvar Excision of Premalignant Lesions: A Double-Blinded Randomized Controlled Trial
In Brief
A Phase 2 clinical trial evaluating Cefazolin for Premalignant Vulvar Lesion and Benign Vulvar Lesion. Completed, enrolled 50 participants across 1 site.
Detailed Summary
A randomized control trial will provide the most reliable data to determine the role of prophylactic antibiotics to decrease the wound complication rate. The investigators plan to perform a pilot study to evaluate actual rates of wound complications and how long it takes to recruit 50 patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPremalignant Vulvar Lesion, Benign Vulvar Lesion
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJul 2018
Enrollment StartJul 2018
Primary CompletionNov 2021
TodayJul 2026
First PostedJul 6, 2018
Enrollment StartJul 13, 2018
Primary CompletionNov 23, 2021
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.0 years ago
Interventions
Cefazolindrug
-If patient has a penicillin allergy then clindamycin will be used. Prophylactic antibiotics should be administered prior to skin incision