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

NCT ID: NCT01912651

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2028-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No antibiotic treatment

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Antibiotics

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 Type: EXPERIMENTAL

cephalexin

Intervention Type: 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.

Interventions

cephalexin

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Moyer

Professor of Otolaryngology-Head and Neck Surgery, Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Y Moyer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Otolaryngology

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jeffrey S Moyer, MD

Role: CONTACT

jmoyer@med.umich.edu

734-936-8051

Facility Contacts

Jeffrey Moyer, MD

Role: primary

jmoyer@med.umich.edu

734-936-8051

Other Identifiers

00046677

Identifier Type: -

Identifier Source: org_study_id