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Antibiotics for Facial Reconstructive Surgery

Phase 4
Recruiting
Led By Jeffrey Y Moyer, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
all adult patients with a nasal or facial skin/soft tissue defect requiring reconstruction limited to or including a full-thickness skin graft
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing whether antibiotics improve healing in patients who have had reconstructive surgery of wounds on their face using skin grafts.

Who is the study for?
This trial is for adults needing facial reconstruction with a full-thickness skin graft, without current or recent antibiotic use, no intolerance to clindamycin and cephalexin, and no previous reconstruction at the defect site.Check my eligibility
What is being tested?
The study tests if post-operative antibiotics (cephalexin) improve the healing of facial skin grafts compared to not using them. The goal is to see if antibiotics should be used despite potential side effects.See study design
What are the potential side effects?
While rare, side effects from cephalexin can include allergic reactions, stomach pain, diarrhea, nausea, vomiting, dizziness and rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I need surgery to repair a skin or soft tissue defect on my nose or face.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Graft failure rate
Secondary outcome measures
Percentage surface area of graft failure

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AntibioticsExperimental Treatment1 Intervention
All patients will receive peri-operative antibiotics per standard practice. This consists of a single dose of cefazolin or, in penicillin allergic patients, clindamycin administered at the time of anesthesia administration prior to the surgical incision. In the cohort randomized to receive post-operative antibiotics, the first choice intervention will be oral cephalexin (500 mg, three times daily or four times daily, for one week). In patients who are penicillin or cephalosporin allergic, we will prescribe clindamycin (300 mg, three times daily or four times daily, for one week).
Group II: No antibiotic treatmentActive Control1 Intervention
Withholding post-operative antibiotics following reconstructive surgery necessitating skin grafting for defects of the face or nose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
cephalexin
2006
Completed Phase 4
~200

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,810 Previous Clinical Trials
6,384,492 Total Patients Enrolled
Jeffrey Y Moyer, MDPrincipal InvestigatorUniversity of Michigan Otolaryngology

Media Library

cephalexin Clinical Trial Eligibility Overview. Trial Name: NCT01912651 — Phase 4
Facial Defect Research Study Groups: No antibiotic treatment, Antibiotics
Facial Defect Clinical Trial 2023: cephalexin Highlights & Side Effects. Trial Name: NCT01912651 — Phase 4
cephalexin 2023 Treatment Timeline for Medical Study. Trial Name: NCT01912651 — Phase 4
~49 spots leftby Sep 2026
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