Status:
COMPLETED
A Randomized, Controlled Trial of the Effectiveness of Perioperative Antibiotics for Reduction of Burn Wound Bacterial Concentration Following Grafting
Lead Sponsor:
Medstar Health Research Institute
Conditions:
Burn
Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04516148
Start Date
May 29 2018
End Date
October 30 2020
Last Update
August 26 2022
Active Locations (1)
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1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010