Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns
Vanderbilt University Medical Center
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.
Description
Patients who sustain burn injuries are some of the most complex patients to care for, often requiring a multidisciplinary team of providers specialized in burn pathophysiology. While many facets of burn care must be accounted for including fluid management, nutrition, respiratory status, immunologic and cardiovascular function, innovation in the treatment for deep partial thickness burns is of paramount importance. Burn depth conversion is a phenomenon where superficial partial-thickness burns spontaneously convert into deep partial-thickness or full-thickness burns, which are associated with…
Eligibility
- Age range
- 50–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provision of signed and dated informed consent form by the subject or Legally Authorized Representative. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Male or female aged 50 to 75 at time of screening visit. * For females of reproductive potential, confirmed negative urine pregnancy test at enrollment. * Presence of deep partial-thickness burns to one or both dorsal hands (burns may be present on other areas of the body, so long as all regions combined are ≤ 5% Total Body Surface Area \[TBSA\], using the Browde…
Interventions
- DrugTacrolimus 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.
Location
- Vanderbilt University Medical CenterNashville, Tennessee