RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-10-01

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04580472

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Mariana Phillips, MD

CONTACT

540-224-5170

maphillips@carilionclinic.org

Jane Gay, BA

CONTACT

jagay01@vt.edu

Principal Investigator

Mariana Phillips, MD

PRINCIPAL_INVESTIGATOR

Carilion Clinic Dermatology and Mohs Surgery

Study Locations (Sites)

Carilion Clinic

Roanoke, Virginia, 24016

United States

Collaborators and Investigators

Sponsor: Carilion Clinic

Mariana Phillips, MD, PRINCIPAL_INVESTIGATOR, Carilion Clinic Dermatology and Mohs Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-01

Study Completion Date2026-09

Study Record Updates

Study Start Date2020-10-01

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Surgical Site Infection