Actively Recruiting
The Role of Antibiotics in Full Thickness Skin Graft Survival for Facial Reconstructive Surgery
Led by University of Michigan · Updated on 2025-03-19
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether antibiotics improve healing and reduce infections after reconstructive facial surgery that uses full-thickness skin grafts. The study aims to determine if post-operative systemic antibiotics help these grafts survive better compared to no post-operative antibiotics. This is a Phase 4 randomized trial led by the University of Michigan, focusing on patients with nasal or facial skin and soft tissue defects. Participants will all receive a single dose of peri-operative antibiotics, either cefazolin or clindamycin for those allergic to penicillin, given before surgery. After surgery, one group will receive oral antibiotics (cephalexin or clindamycin for allergies) three or four times daily for one week, while the other group will not receive any post-operative antibiotics. The study will monitor the effects of these treatments over time. Participants will be followed up at 2 to 6 weeks, 6 months, and 1 year after surgery. Researchers will assess graft failure rates and the percentage of graft surface area lost at one year. These evaluations will help determine the impact of antibiotics on skin graft survival and wound healing outcomes, aiming to guide future treatment recommendations.
CONDITIONS
Brief Title
The Role of Antibiotics in Full Thickness Skin Graft Survival for Facial Reconstructive Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with a nasal or facial skin or soft tissue defect requiring reconstruction including a full-thickness skin graft
You will not qualify if you...
- Current or recent systemic antibiotic use within one week of surgery
- Intolerance or allergy to both clindamycin and cephalexin
- Discovery of a persistent skin cancer at the defect site after reconstructive surgery
- Previous reconstruction surgery at the site of the skin or soft tissue defect
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants receive peri-operative antibiotics at the time of surgery. Those randomized to post-operative antibiotics take oral cephalexin or clindamycin for one week following surgery.
1 surgical visit plus medication at home
Duration - Up to 1 year
Participants are followed up for outcome assessments to monitor graft survival and potential complications after surgery.
Visits at 2 to 6 weeks, 6 months, and 1 year post-surgery
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
J
Jeffrey S Moyer, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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