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

NCT04516148 | Completed Phase 4 FDA Drug

• 1 other identifier: 2017-186
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn; Surgery; Infection Wound

Keywords

microbiome; perioperative; antibiotics; autograft; xenograft

Outcome Measures

Primary Outcomes (1)

• burn wound bacterial concentration

  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.

  1-3 days from surgery

Study Arms (2)

Antibiotics

EXPERIMENTAL

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; Drug: Clindamycin

Standard of Care

NO INTERVENTION

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.

Interventions

Cefazolin DRUG

Dosing per hospital policy

Antibiotics

Clindamycin DRUG

Dosing per hospital policy

Antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Burns; Wound Infection

Interventions

Cefazolin; Clindamycin

Condition Hierarchy (Ancestors)

Wounds and Injuries; Infections

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 18, 2020
• Study Start: May 29, 2018
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

US (1)