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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT05856994
Phase
PHASE1
Status
Recruiting
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Conditions

  • Burn Injury

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tacrolimus ointment — DRUG
    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.

Study Details

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 Dates

Start date
Sep 19, 2024
Status verified
Oct 2025
Primary completion
Dec 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tacrolimus Ointment 0.03% with hydrocolloid dressing
    Standard out-patient wound cleaning followed by application of tacrolimus ointment over the burn and hydrocolloid dressing on the treated area.
  • No Intervention: Bacitracin ointment
    Standard out-patient wound cleaning followed by application of bacitracin ointment over the burn and hydrocolloid dressing on the treated area.
  • No Intervention: Hydrocolloid dressing
    Standard out-patient wound cleaning followed by application of hydrocolloid dressing on the burned area.

Primary Outcome Measure

Time to complete wound healing [ Time Frame: 21 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232-

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