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RECRUITING
NCT05856994
PHASE1

Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

Summary

There is currently no standard treatment to prevent burn depth conversion in partial-thickness burns. Conversion into deeper wounds is associated with higher complications and morbidity. The most common theory attributes this depth conversion to the prolonged inflammatory response that occurs after burn injury. Therefore, the investigators propose testing the safety and efficacy of tacrolimus ointment (an immunosuppressive agent) in patients with deep partial-thickness burns.

Key Details

Gender

All

Age Range

50 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2024-09-19

Completion Date

2028-06-01

Last Updated

2025-10-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tacrolimus ointment

For the active comparator group, the wound(s) will be cleaned and bacitracin ointment will be applied to the wound. External dressings on all treated wounds will be placed based on the current standard of care. For the control group, the wound(s) will be cleaned and a hydrocolloid Dressing will be affixed to the burn and treated area. For the treatment group, the wound(s) will be cleaned and tacrolimus (0.03%) ointment will be applied over the burn. Hydrocolloid Dressing will be affixed to the burn and treated area. External dressings on all treated wounds will be placed based on the current standard of care.

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States