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

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · May 3, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the use of Protopic® ointment (a medication that helps reduce inflammation) to see if it can safely and effectively prevent deep partial-thickness burns from becoming worse. These types of burns can lead to more serious injuries and complications, so finding a better treatment is important. The study is currently looking for participants, specifically men and women aged 50 to 75, who have deep partial-thickness burns on the backs of their hands. To be eligible, participants must be able to start treatment within 1-2 days after the burn occurs and agree to follow the study procedures.

If you decide to participate, you'll need to provide consent and attend follow-up visits to monitor your progress. It's important to note that certain conditions may exclude you from participating, such as being pregnant or having an active infection. This trial is a crucial step toward improving care for burn injuries, and your involvement could help researchers understand more about how to treat these burns effectively.

Gender

ALL

Eligibility criteria

• 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 Browder and Lund Chart).
• • Thermal burn (caused by fire, hot objects, steam or hot liquids \[scalding\]) etiology, located on one or both dorsal hands.
• • Ability to implement treatment within 24-48 hours days of the initial burn.
• Exclusion Criteria:
• • 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.
• • Subject is incarcerated.
• • Friction, chemical or electric burn etiology.
• • Immunosuppression, as determined by the Principal Investigator.
• • Presence of a local and/or systemic infection that, in the Investigator's opinion, requires aggressive treatment which would warrant exclusion from participating in this study.
• • Subject is unwilling or unable to follow study related procedures and/or follow-up visits.
• • Prior treatment to the burn wound(s) on the hand(s) considered for this trial with another product (treatment failure).
• • Subject report of previous participation in another interventional burn wound study within 60 days prior to the Screening Visit.
• • Subject report of concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
• • The subject has any physical or psychiatric condition that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study.