Clinical Trial

Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery

Active, Not Recruiting Phase 4
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Summary
The purpose of the study is to assess the effectiveness of a single dose of preoperative antibiotic in reducing surgical site infections in certain dermatological procedures. Patients will undergo surgical excision or Mohs surgery as is clinically indicated and part of usual care. The study will be a double blinded, placebo-controlled clinical trial. Patients meeting inclusion criteria will be assigned to one of three participant categories: 1) patients undergoing repair with skin flap or graft on the nose, 2) patients undergoing repair with skin graft, flap, or wedge resection on the ear, or 3) patients undergoing Mohs surgery with closure or partial closure or surgical excision on the lower extremity below the knee. Within each category, participants will be randomized into one of two groups: group one will receive a preoperative placebo pill and group two will receive preoperative antibiotic prophylaxis (either a single dose of Cephalexin 2g PO or single dose of Clindamycin hydrochloride 600 mg PO if allergy to penicillin or cephalosporin). Patients will followed for 30 days +/- 7 after surgery to evaluate for any surgical site infection.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2020-10-06; most recent amendment 2026-03-23.
Status change: Recruiting → Active, Not Recruiting 2026-03-23
Status change: Not Yet Recruiting → Recruiting 2021-05-19
Trial Details
NCT Number NCT04580472
Lead Sponsor Carilion Clinic
Conditions Surgical Site Infection
Enrollment 574 participants
Start Date 2020-10-01
Primary Completion 2026-09 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-03-25