Burn, Infection Wound, Surgery
Conditions
Keywords
microbiome, perioperative, antibiotics, autograft, xenograft
Brief summary
The purpose of this study if to evaluate the effectiveness of prophylactic antibiotics given during surgery in reducing the concentration of bacteria in a burn wound after surgery.
Detailed description
This is a single-blind, randomized, controlled study to assess the effectiveness and safety of prophylactic perioperative administration of antibiotics for the reduction of bacterial concentration in burn wounds. Subjects who meet enrollment criteria will be randomized in a 1:1 ratio to receive either perioperative prophylaxis with intravenous antibiotics or institutional standard of care, consisting of no antibiotic therapy. This with be a single center study. Following randomization, patients will receive their assigned treatment (antibiotics or standard of care) after induction of anesthesia, no more than one hour prior to incision. Patients weighing 120 kg or less will receive 2 grams of intravenous cefazolin, with those weighing \> 120 kg receiving 3 grams intravenous cefazolin. Re-dosing will occur every 4 hours that the patient remains in the operating room. For patients with a documented beta-lactam allergy, Clindamycin 900 mg will be given intravenously with re-dosing every 6 hours that the patient remains in the operating room. Patients with allergies to both agents will be excluded from the study. Biological samples will be obtained at three primary time-points: intraoperatively, at the time of the initial postoperative dressing take-down (within six hours), and at the time of a single follow up visit (10-28 days postoperatively).
Interventions
DRUGCefazolin
Dosing per hospital policy
DRUGClindamycin
Dosing per hospital policy
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject age ≥ 18 years old at the time of consent 2. Burn wound sustained less than 48 hours prior to the time of presentation to MedStar Washington Hospital Center 3. Burn wounds solely due to a thermal mechanism 4. Total body surface area burned ≤ 10% 5. Anticipated to require a single grafting procedure 6. Able to provide informed consent to participate
Exclusion criteria
1. Positive pregnancy test in females of child bearing age 2. Antibiotic administration within 30 days prior to admission 3. Known / documented beta lactam allergy and clindamycin allergy 4. Presence of burn wound cellulitis or infection pre-operatively 5. Intraoperative discovery of infection 6. Incarceration 7. Presence of factors that may affect wound healing, per clinician judgment, such as chronic malnutrition and immunocompromised state
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| burn wound bacterial concentration | 1-3 days from surgery | The primary effectiveness endpoint is a statistically significant reduction in the burn wound bacterial concentration in wounds where patients received antibiotics. Samples (tissue swabs and punch biopsies) obtained intraoperatively following wound bed preparation will be compared to samples (tissue swabs and punch biopsies) obtained from the wound within six hours of initial postoperative dressing take-down. |
Countries
United States
Outcome results
None listed