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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Carilion Clinic

Roanoke, Virginia, 24016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 years of age or older
presenting to Carilion Clinic Dermatology and Mohs surgery in Roanoke, VA at Riverside 1
suspected to undergo a single-staged repair including a skin flap or graft on the nose
OR suspected to undergo single-staged repair including a skin graft or flap or wedge resection 1 on the ear
OR undergoing Mohs with closure or partial closure or surgical excision on the lower extremity below the knee

Exclusion criteria

patients with intellectual or mental impairment affecting ability to give informed consent
use of any antibiotic (other than intervention) within 48 hours of the surgery suspected infection at time of surgery
inability to take cephalexin or clindamycin hydrochloride due to allergy or intolerance current inflammatory skin disease affecting the surgical site
Patients undergoing concurrent surgery to oral or nasal mucosa
Patients who have had a recent prosthetic joint surgery within two years and have been told they require antibiotic prophylaxis.
Patients who are currently pregnant, concerned they could be pregnant, actively trying to conceive, or missed last menstrual period that is not explainable by a birth control method.

Treatment and study plan

Cephalexin

Drug

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 names: Clindamycin hydrochloride

Placebo Capsules

Other

Patients will receive 4 placebo capsules prior to surgery if randomized to placebo group.

Primary outcomes

Development of surgical site infection within 30 days of surgery

Time frame: 30 days

Rate of surgical site infection occurrence

Sponsors and collaborators

Lead sponsor

Carilion Clinic

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2026
Study completion: 2026
First posted: Oct 8, 2020
Registry last updated: Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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