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

ConditionFacial Defect

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: No antibiotic treatmentNo intervention 0 interventions

Group B: AntibioticsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Graft failure rate

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

Time frame

1 year

Secondary outcomes

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.

Time frame

1 year

Sponsors and contacts

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University of Michigan

Lead sponsor

Source ClinicalTrials.gov

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