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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2026-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Placebo - leg

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

Group Type PLACEBO_COMPARATOR

Placebo capsules

Intervention Type OTHER

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

Antibiotic- leg

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

Group Type EXPERIMENTAL

Cephalexin

Intervention Type 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.

Placebo- nose

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

Group Type PLACEBO_COMPARATOR

Placebo capsules

Intervention Type OTHER

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

Antibiotic- nose

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.

Group Type EXPERIMENTAL

Cephalexin

Intervention Type 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.

Placebo- ear

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

Group Type PLACEBO_COMPARATOR

Placebo capsules

Intervention Type OTHER

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

Antibiotic- ear

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.

Group Type EXPERIMENTAL

Cephalexin

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Placebo capsules

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

Intervention Type OTHER

Other Intervention Names

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Clindamycin hydrochloride

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No