A Randomized Controlled Trial of the Effectiveness of Perioperative Antibiotics for Reduction of Burn Wound Bacterial Concentration Following Grafting

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    80
  • sponsor
    Medstar Health Research Institute
Updated on 23 August 2020
Investigator
John Keyloun, MD
Primary Contact
MedStar Washington Hospital Center (5.3 mi away) Contact
antibiotics
grafting procedure

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.

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).

Details
Treatment Clindamycin, Cefazolin
Clinical Study IdentifierNCT04516148
SponsorMedstar Health Research Institute
Last Modified on23 August 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Wound Infection or Surgery or Surgical aspects or Burns or Burns and Burn Infections?
Subject age 18 years old at the time of consent
Burn wound sustained less than 48 hours prior to the time of presentation to MedStar Washington Hospital Center
Burn wounds solely due to a thermal mechanism
Total body surface area burned 10%
Anticipated to require a single grafting procedure
Able to provide informed consent to participate

Exclusion Criteria

Positive pregnancy test in females of child bearing age
Antibiotic administration within 30 days prior to admission
Known / documented beta lactam allergy and clindamycin allergy
Presence of burn wound cellulitis or infection pre-operatively
Intraoperative discovery of infection
Incarceration
Presence of factors that may affect wound healing, per clinician judgment, such as chronic malnutrition and immunocompromised state
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