Clinical trial NCT04516148: A Randomized, Controlled Trial of the Effectiveness of Perioperative Antibiotics for Reduction of Burn Wound Bacterial Concentration Following Grafting
Official title: A Randomized, Controlled Trial of the Effectiveness of Perioperative Antibiotics for Reduction of Burn Wound Bacterial Concentration Following Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Burn
Surgery
Infection Wound
Keywords: microbiome
perioperative
antibiotics
autograft
xenograft
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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

Primary outcomes:
measure: burn wound bacterial concentration
timeFrame: 1-3 days from surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
References: