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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04516148
• Other study ID #: 2017-186
• Status: Completed
• Phase: Phase 4
• Start date: May 29, 2018
• Est. completion date: October 30, 2020

Study information

• Verified date: August 2022
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burn
• Burns
• Infection Wound
• Surgery
• Wounds and Injuries

Intervention

Drug:
• Cefazolin
Dosing per hospital policy
• Clindamycin
Dosing per hospital policy

Locations

Country	Name	City	State
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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