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Clinical Trial 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.


Clinical Trial 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 higher complications and morbidity. The most common theory attributes this depth conversion to the prolonged inflammatory response that occurs after burn injury. Excess inflammation worsens the injury through various mechanisms, including cytokine production, delayed inflammatory cell apoptosis, and reactive oxidative species production. Protopic® (tacrolimus) Ointment is a macrolide immunosuppressant and a calcineurin inhibitor. Tacrolimus inhibits T-lymphocyte activation, a key cell in the body's immune response. A prolonged inflammatory response is theorized to contribute to a worse recovery outcome in partial- to full-thickness burns. Therefore, tacrolimus possesses properties that could slow the acute inflammatory response and potentially improve clinical outcomes in deep partial-thickness burns. There has yet to be a clinical study to investigate the use of tacrolimus in burn treatment. However, our group recently published an animal study that found a significant reduction in burn depth using tacrolimus topically (White-Dzuro et al. Burns 2022). This study is a randomized clinical trial of the usage of tacrolimus ointment for the treatment of deep partial-thickness burns with comprehensive assessments of healing and functional outcomes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05856994
Study type Interventional
Source Vanderbilt University Medical Center
Contact Wesley Thayer, MD, PhD
Phone 6159360160
Email wesley.thayer@vumc.org
Status Recruiting
Phase Phase 1
Start date August 1, 2023
Completion date June 1, 2025

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