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

Sponsor

Medstar Health Research Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT04516148

Collaborator

(none)

Enrollment

Location

Arms

43.1

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burn Surgery Infection Wound	Drug: Cefazolin Drug: Clindamycin	Phase 4

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 29, 2018

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Antibiotics Patients randomized to the treatment arm of the study will have orders placed by a physician on the clinical team, with preparation and delivery of the antibiotics dose by the pharmacy following standard procedures. Antibiotic administration will occur after induction of anesthesia, with delivery by the Anesthesia staff no more than one hour prior to incision. Those with known allergy to beta-lactams will receive clindamycin instead of cefazolin.	Drug: Cefazolin Dosing per hospital policy Drug: Clindamycin Dosing per hospital policy
No Intervention: Standard of Care Patients randomized to the standard of care arm of the study will receive no perioperative antibiotic administration and will proceed with routine pre-operative care.

Arm

Intervention/Treatment

Experimental: Antibiotics

Patients randomized to the treatment arm of the study will have orders placed by a physician on the clinical team, with preparation and delivery of the antibiotics dose by the pharmacy following standard procedures. Antibiotic administration will occur after induction of anesthesia, with delivery by the Anesthesia staff no more than one hour prior to incision. Those with known allergy to beta-lactams will receive clindamycin instead of cefazolin.

Drug: Cefazolin

Dosing per hospital policy

Drug: Clindamycin

Dosing per hospital policy

No Intervention: Standard of Care

Patients randomized to the standard of care arm of the study will receive no perioperative antibiotic administration and will proceed with routine pre-operative care.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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