300 Participants Needed

Antibiotics for Facial Reconstructive Surgery

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Overseen ByJeffrey S Moyer, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 5 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used systemic antibiotics within one week before surgery.

What data supports the effectiveness of the drug cephalexin for facial reconstructive surgery?

Cephalexin is effective in treating skin and soft-tissue infections, achieving cure rates of 90% or higher, which suggests it could be beneficial in preventing infections after facial reconstructive surgery. Additionally, in a study on endoscopic skull base surgery, a regimen including cephalexin showed low rates of postoperative infections, supporting its use in surgical settings.12345

Is cephalexin safe for use in humans?

Cephalexin, a type of antibiotic, is generally safe for treating skin and soft tissue infections, with common side effects being mild skin reactions and stomach issues. In studies, only about 5% of patients stopped using it due to side effects, indicating it is well-tolerated by most people.678910

How does the drug used in the clinical trial for facial reconstructive surgery differ from other treatments?

The antibiotics used in the trial, such as ceftriaxone, are unique because they can be administered as a single daily dose due to their long half-life, making them more convenient and cost-effective compared to other antibiotics like cefotaxime, which require more frequent dosing.1231112

What is the purpose of 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.

Research Team

JY

Jeffrey Y Moyer, MD

Principal Investigator

University of Michigan Otolaryngology

Eligibility Criteria

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.

Inclusion Criteria

I need surgery to repair a skin or soft tissue defect on my nose or face.

Exclusion Criteria

I have had reconstruction surgery at the site of my skin or soft-tissue defect before.
I found skin cancer at the site of my recent surgery.
intolerance to both clindamycin and cephalexin
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive peri-operative antibiotics and, for some, post-operative antibiotics to assess their impact on skin graft survival

1 week
1 visit (in-person) for surgery and initial treatment

Follow-up

Participants are monitored for graft survival and any post-operative complications

1 year
Regular follow-up visits as needed

Treatment Details

Interventions

  • Cephalexin
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

Findings from Research

In a study of 60 patients undergoing cervicofacial surgery, both cefotaxime and ceftriaxone were effective as short-term prophylactic antibiotics, with only one postoperative infection observed.
Ceftriaxone is advantageous due to its longer half-life, allowing for a single daily dose, and it is also more cost-effective compared to cefotaxime.
Antimicrobial prophylaxis in head and neck surgery.Panosetti, E., Lehmann, W., Smolik, JC.[2018]
Cephalexin is a highly effective antibiotic for treating streptococcal and staphylococcal skin infections, achieving cure rates of 90% or higher over 12 years of use.
It is well-absorbed and bioavailable, with a twice-daily dosage that improves patient compliance, and its mild side effects make it suitable for young children.
The role of cephalexin in the treatment of skin and soft-tissue infections.Derrick, CW., Reilly, K.[2013]
In a study involving 350 patients, the use of single intravenous injections of antibiotics (Ceftriaxon, Rocifen, Lyncomycin) before surgery effectively prevented postoperative purulent complications in closed mandibular fractures and reconstructive maxillo-facial operations.
The antibiotics also significantly reduced the frequency of complications in cases of open fractures of the mandible and nasal bones, highlighting their efficacy in maxillo-facial surgery.
[Prevention of postoperative inflammatory complications in patients with maxillo-facial region pathology].Basitkhanova, EI.[2012]

References

Antimicrobial prophylaxis in head and neck surgery. [2018]
The role of cephalexin in the treatment of skin and soft-tissue infections. [2013]
3.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Prevention of postoperative inflammatory complications in patients with maxillo-facial region pathology]. [2012]
Perioperative Antibiotic Use in Endoscopic Endonasal Skull Base Surgery. [2022]
A randomized prospective study of oral versus intravenous antibiotic prophylaxis against postoperative infection after sagittal split ramus osteotomy of the mandible. [2022]
6.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[A study of the efficacy and safety of new cephalosporin in the treatment of acute bacterial rhinosinusitis]. [2018]
Comparative study of cephalexin hydrochloride and cephalexin monohydrate in the treatment of skin and soft tissue infections. [2021]
Adverse Reactions Associated with Penicillins, Carbapenems, Monobactams, and Clindamycin: A Retrospective Population-based Study. [2021]
Third generation cephalosporins: safety profiles after 10 years of clinical use. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Are Cephalosporins Safe for Surgical Prophylaxis in Patients with Penicillin Allergy? [2023]
[Short-term antibiotic prophylaxis with ceftriaxone in general surgery]. [2013]
12.United Statespubmed.ncbi.nlm.nih.gov
Cephalexin, a new orally absorbed cephalosporin antibiotic. [2021]
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