← Back to Search

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,797 Previous Clinical Trials

6,377,758 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has cephalexin been certified by the FDA?

"Evidence from the trial supports cephalexin's safety, so it was awarded a rating of 3."

Answered by AI

How many people have enrolled in this medical research project thus far?

"Affirmative, the information on clinicaltrials.gov attests to this investigation's active recruitment status. Originally posted on July 1st 2013, it seeks 300 subjects from a single trial site and was last updated May 27th 2022."

Answered by AI

Are there still spots remaining for this experiment?

"Affirmative. Clinicaltrials.gov records demonstrate that this research is currently looking for participants, having been first published on July 1st 2013 and updated as recently as May 27th 2022. 300 patients are required across a single medical centre."

Answered by AI

What other research has been done investigating cephalexin's efficacy?

"Presently, there are 14 ongoing studies which explore cephalexin. 3 of these investigations have reached Phase 3 status. Morgantown, West virginia is the centre for most of the trials but 44 different medical centres across America are running tests with this drug."

Answered by AI

To what types of ailments does cephalexin offer a potential remedy?

"Cephalexin is a frequently prescribed medication to combat streptococcus pneumoniae, as well as otitis media (OM), genitourinary tract infection and other communicable diseases."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Role of Antibiotics in Full Thickness Skin Graft Survival for Facial Reconstructive Surgery

Jeffrey Moyer 2013. "The Role of Antibiotics in Full Thickness Skin Graft Survival for Facial Reconstructive Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01912651.

All > Paid Studies Michigan