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

Facial Defect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01912651
• Other study ID #: 00046677
• Status: Recruiting
• Phase: Phase 4
• Start date: July 2013
• Est. completion date: September 2026

Study information

• Verified date: April 2024
• Source: University of Michigan
• Contact: Jeffrey S Moyer, MD
• Phone: 734-936-8051
• Email: jmoyer[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Facial Defect
• Facies

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage surface area of graft failure	The secondary outcomes include the percentage surface area of graft failure, the incidence of post-operative adjunctive procedures related to graft cosmesis and the incidence of revision surgery resulting from graft failure.	1 year