Actively Recruiting
Clinical Assessment of Protopic ae Ointment for Deep Partial-Thickness Burns in Adults Aged 50 to 75
Led by Vanderbilt University Medical Center · Updated on 2025-10-20
18
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effects of tacrolimus ointment in treating deep partial-thickness burns, a condition where burns can worsen and deepen over time, leading to more complications. There is currently no standard treatment to prevent this worsening, which is thought to be caused by prolonged inflammation after injury. The study is a randomized clinical trial led by Vanderbilt University Medical Center to investigate whether tacrolimus ointment can reduce burn depth and improve healing outcomes. Participants will be randomly assigned to one of three groups: one receiving tacrolimus ointment with a hydrocolloid dressing, another receiving bacitracin ointment with a hydrocolloid dressing, and a third group receiving only a hydrocolloid dressing after standard wound cleaning. Treatments will be applied to burns on the dorsal hands, and the study will monitor how each approach affects wound healing. The trial includes a phase 1 evaluation and uses standard outpatient wound care procedures. During the study, participants will be monitored for wound healing time, assessed for functional outcomes, and observed for any adverse effects. The primary outcome is the time to complete wound healing within 21 days. Participants will attend follow-up visits to track progress, and their wounds will be regularly cleaned and dressed according to the assigned treatment. The total study duration and exact visit schedule are determined by the protocol and participant progress.
CONDITIONS
Brief Title
Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form by the participant or legal representative
- Willingness to comply with all study procedures and available for the study duration
- Male or female aged 50 to 75 at screening
- For females of reproductive potential, a confirmed negative urine pregnancy test at enrollment
- Presence of deep partial-thickness burns on one or both dorsal hands
- Thermal burn caused by fire, hot objects, steam, or hot liquids located on one or both dorsal hands
- Ability to start treatment within 24 to 48 hours of the initial burn
- Total burn area on all body regions combined is 5% or less of total body surface area using the Browder and Lund Chart
You will not qualify if you...
- Pregnant, breastfeeding, or unwilling to use birth control during the study if applicable
- Any condition that compromises safety or data quality as judged by the investigator
- Allergy or sensitivity to tacrolimus or ointment components, or personal refusal
- Allergy or sensitivity to bacitracin or its components, including possible neomycin sensitivity
- Being incarcerated
- Burns caused by friction, chemical, or electric sources
- Immunosuppression as determined by the principal investigator
- Local or systemic infection requiring aggressive treatment
- Unwilling or unable to follow study procedures or attend follow-up visits
- Prior treatment of the burn wound on the hand with another product considered a treatment failure
- Participation in another interventional burn wound study within 60 days before screening
- Concurrent participation in another clinical trial involving investigational drugs or devices that interfere with this study
- Physical or psychiatric conditions preventing study completion as judged by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 days or until complete wound healing
Participants receive wound cleaning followed by application of either tacrolimus ointment with hydrocolloid dressing, bacitracin ointment with hydrocolloid dressing, or hydrocolloid dressing alone to treat deep partial-thickness burns on the dorsal hands.
Regular visits until wound healing
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
W
Wesley Thayer, MD, PhD
J
Julia Yao, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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