NCT04580472

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 574 (actual)
• Sponsor: Carilion Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	Cephalexin	If randomized to the antibiotic group, a single dose of cephalexin or clindamycin hydrochloride (if concern for previous allergy to Cephalexin) will be given prior to surgery.
OTHER	Placebo capsules	Patients will receive 4 placebo capsules prior to surgery if randomized to placebo group.

Timeline

• Start date: 2020-10-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2020-10-08
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study