Using a single dose of oral antibiotics to prevent infections after skin surgery
Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery
This study tests if taking one dose of antibiotics before skin surgery can help prevent infections for patients having procedures like skin flap repairs or Mohs surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Carilion Clinic Academic / other |
| Locations | 1 site (Roanoke, Virginia) |
| Trial ID | NCT04580472 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a single preoperative dose of antibiotics in preventing surgical site infections in patients undergoing specific dermatological procedures. It is a double-blinded, placebo-controlled trial where participants will be randomized into two groups: one receiving the antibiotic and the other receiving a placebo. The focus is on patients undergoing skin flap or graft repairs on the nose or ear, or Mohs surgery on the lower extremity. The study aims to determine if antibiotic prophylaxis can significantly reduce the incidence of infections following these surgeries.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for specific dermatological surgeries at Carilion Clinic in Roanoke, VA.
Not a fit: Patients with recent antibiotic use, certain allergies, or concurrent surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of surgical site infections in dermatologic surgeries, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promising results with antibiotic prophylaxis in surgical settings, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Roanoke, Virginia
- Carilion Clinic — Roanoke, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Mariana Phillips, MD — Carilion Clinic Dermatology and Mohs Surgery
- Study coordinator: Mariana Phillips, MD
- Email: maphillips@carilionclinic.org
- Phone: 540-224-5170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.