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

NCT01912651 | Recruiting Phase 4 DMC

• 1 other identifier: 00046677
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Antibiotics are sometimes prescribed to patients who have had reconstructive surgery of wounds on their face using skin grafts. But, it is not yet known whether antibiotics improve the healing of skin grafts and reduce the risk of infections after surgery in these patients. It is known that antibiotics, like all medications, have side-effects although these are rare. This research study is designed to show us whether antibiotics improve wound healing or not, so that we may determine if we should continue using antibiotics even if they have side-effects in some patients. Our hypothesis is that patients treated with post-operative, systemic antibiotics will demonstrate a statistically significant improvement in the survival of their facial full thickness skin grafts compared to patients who are not treated with systemic antibiotics.

Conditions

Facial Defect

Keywords

facial skin wound; facial wound; skin wound; facial defect; reconstructive skin graft

Outcome Measures

Primary Outcomes (1)

• Graft failure rate

  The primary outcomes will be graft failure rate where failure is defined as any tissue loss extending beyond the epithelium.

  1 year

Secondary Outcomes (1)

• Percentage surface area of graft failure

  1 year

Study Arms (2)

No antibiotic treatment

NO INTERVENTION

Withholding post-operative antibiotics following reconstructive surgery necessitating skin grafting for defects of the face or nose.

Antibiotics

EXPERIMENTAL

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).

Drug: cephalexin

Interventions

cephalexin DRUG

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). Patients will be followed up within 2 to 6 weeks of surgery and outcome measures assessed. Patients will, again, be seen at 6 months and 1 year post-operatively for outcome assessment.

Antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all adult patients with a nasal or facial skin/soft tissue defect requiring reconstruction limited to or including a full-thickness skin graft

You may not qualify if:

• current or recent (within one week of surgery) systemic antibiotic use, intolerance to both clindamycin and cephalexin, discovery of a persistent cutaneous malignancy at the site of the defect following the reconstructive procedure and previous reconstruction at the site of the skin/soft-tissue defect.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Interventions

Cephalexin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jeffrey Y Moyer, MD

  University of Michigan Otolaryngology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey S Moyer, MD

CONTACT

734-936-8051; jmoyer@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology-Head and Neck Surgery, Medical School

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: July 31, 2013
• Study Start: July 1, 2013
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

US (1)