Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns
ConditionBurn Injury
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age50-75
SponsorVanderbilt University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable.
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Allergy or hypersensitivity to tacrolimus or other components of the ointment (per subject report) or personal preference.
Allergy or hypersensitivity to bacitracin and/or any of its drug formulation components. Patients with known hypersensitivity to neomycin may also be sensitive to bacitracin.
Trial design
Design model
Parallel
Treatments tested in this trial
Tacrolimus ointment
DrugFor 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.
Treatment groups
18 Participants
are divided into 3 treatment groupsGroup A: Tacrolimus Ointment 0.03% with hydrocolloid dressingExperimental treatment 1 intervention
Group B: Bacitracin ointmentNo intervention 0 interventions
Group C: Hydrocolloid dressingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Time to complete wound healing
Clinical burn wound assessment
Time frame
21 daysSponsors and contacts
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Source ClinicalTrials.gov