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

Carilion Clinic

Status and phase: Enrolling; Phase 4

Conditions: Surgical Site Infection

Treatments: Other: Placebo capsules; Drug: Cephalexin

Study type: Interventional

Funder types: Other

Identifiers

NCT04580472

IRB-19-482

Details and patient eligibility

About

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.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,600 participants in 6 patient groups, including a placebo group

Placebo - leg

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo capsules

Antibiotic- leg

Experimental group

Description:

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

Treatment:

Drug: Cephalexin

Placebo- nose

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo capsules

Antibiotic- nose

Experimental group

Description:

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.

Treatment:

Drug: Cephalexin

Placebo- ear

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo capsules

Antibiotic- ear

Experimental group

Description:

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.

Treatment:

Drug: Cephalexin