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

NCT04580472 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB-19-482
• Study Type: interventional
• Target: 574
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Development of surgical site infection within 30 days of surgery

  Rate of surgical site infection occurrence

  30 days

Study Arms (6)

Placebo - leg

PLACEBO COMPARATOR

If randomized to placebo group, 4 placebo capsules will be administered PO 30 minutes prior to incision in the leg group.

Other: Placebo capsules

Antibiotic- leg

EXPERIMENTAL

The administration time of the oral antibiotics will be 30 minutes prior to incision in the leg group. 4-500 mg capsules of cephalexin will be administered to the patient. If there is concern for previous allergy to cephalexin, 4-150 mg capsules of clindamycin hydrochloride will be administered

Drug: Cephalexin

Placebo- nose

PLACEBO COMPARATOR

If randomized to placebo group, 4 placebo capsules will be administered PO 5-15 minutes prior to surgery on the nose.

Other: Placebo capsules

Antibiotic- nose

EXPERIMENTAL

The administration time of the oral antibiotics will be 5-15 minutes prior to surgery on the nose. 4-500 mg capsules of cephalexin will be administered to the patient. If there is concern for previous allergy to cephalexin, 4-150 mg capsules of clindamycin hydrochloride will be administered PO.

Drug: Cephalexin

Placebo- ear

PLACEBO COMPARATOR

If randomized to placebo group, 4 placebo capsules will be administered PO 5-15 minutes prior to surgery on the ear.

Other: Placebo capsules

Antibiotic- ear

EXPERIMENTAL

The administration time of the oral antibiotics will be 5-15 minutes prior to surgery on the ear. 4-500 mg capsules of cephalexin will be administered to the patient. If there is concern for previous allergy to cephalexin, 4-150 mg capsules of clindamycin hydrochloride will be administered PO.

Drug: Cephalexin

Interventions

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.

Also known as: Clindamycin hydrochloride

Antibiotic- ear; Antibiotic- leg; Antibiotic- nose

Placebo capsules OTHER

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

Placebo - leg; Placebo- ear; Placebo- nose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Cephalexin; Clindamycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates

Study Officials

• Mariana Phillips, MD

  Carilion Clinic Dermatology and Mohs Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will not be told if they are receiving the antibiotic or placebo. Dermatologic surgeons who are performing the surgery and assessing for surgical site infections will be blinded to which arm of the study the patient is randomized. In order to accomplish this, study nurses will be responsible for randomizing each participant and will administer the antibiotic or placebo to each participant after each patient has consented and after the dermatologic surgeon has placed the order for "cephalexin/placebo" or "clindamycin/placebo" (based on patient's allergies) in the electronic medical record.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Section Chief of Dermatology & Mohs Surgery

Model Details: 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). These doses for cephalexin and clindamycin hydrochloride are standard doses for adults. The administration time of the oral antibiotics (as well for placebo group) will be 5-15 minutes prior to surgery in the nose and ear group and 30 minutes prior incision in the leg group.

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: October 8, 2020
• Study Start: October 1, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)