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.

Study Overview

• Status: Recruiting
• Conditions: Surgical Site Infection
• Intervention / Treatment: Other: Placebo capsules; Drug: Cephalexin

• Study Type: Interventional
• Enrollment (Anticipated): 1600
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mariana Phillips, MD; Phone Number: 540-224-5170; Email: maphillips@carilionclinic.org
• Study Contact Backup: Name: Jane Gay, BA; Email: jagay01@vt.edu

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Recruiting
      • Carilion Clinic
      • Contact: Mariana Phillips; Phone Number: 540-224-5170; Email: maphillips@carilionclinic.org
      • Contact: Jane Gay; Phone Number: 5403368811; Email: jagay01@vt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo - leg; If randomized to placebo group, 4 placebo capsules will be administered PO 30 minutes prior to incision in the leg group.	Other: Placebo capsules; Patients will receive 4 placebo capsules prior to surgery if randomized to placebo group.
Experimental: 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	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 Names: Clindamycin hydrochloride
Placebo Comparator: Placebo- nose; If randomized to placebo group, 4 placebo capsules will be administered PO 5-15 minutes prior to surgery on the nose.	Other: Placebo capsules; Patients will receive 4 placebo capsules prior to surgery if randomized to placebo group.
Experimental: 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.	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 Names: Clindamycin hydrochloride
Placebo Comparator: Placebo- ear; If randomized to placebo group, 4 placebo capsules will be administered PO 5-15 minutes prior to surgery on the ear.	Other: Placebo capsules; Patients will receive 4 placebo capsules prior to surgery if randomized to placebo group.
Experimental: 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.	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 Names: Clindamycin hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of surgical site infection within 30 days of surgery	Rate of surgical site infection occurrence	30 days

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Investigators: Principal Investigator: Mariana Phillips, MD, Carilion Clinic Dermatology and Mohs Surgery

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Cephalexin
• Other Study ID Numbers: IRB-19-482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes