STAT: Standard Therapy Plus Active Therapy

Launched by AMERICAN BURN ASSOCIATION · Apr 27, 2020

Keywords

ClinConnect Summary

The STAT clinical trial is exploring a new therapy called Standard Therapy Plus Active Therapy (STAT) to see if it can help people recover better from burn injuries compared to standard treatment alone. This study is being conducted at seven burn centers and aims to find out if the activity-based therapy can improve how well patients function and reduce any disabilities caused by their burns.

To participate in this trial, individuals need to be between 18 and 65 years old and have suffered severe burns covering at least 15% of their body, including at least 10% of that as third-degree burns, which are the most serious type. Patients will be randomly assigned to either the new therapy or the standard treatment. Those who join will receive close monitoring and support throughout their recovery, and it’s important that they can return for follow-up visits after their treatment. If you or someone you know is recovering from significant burn injuries and meets these criteria, this trial may offer a valuable opportunity to explore a potentially beneficial therapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 to 65 years old
• • 2. Total TBSA of 15% or greater with at least 10% TBSA of third-degree burn
• • 3. Potential need for a skin graft procedure determined by the local burn surgeon
• • 4. Survivable burn injury determined by the admitting local burn surgeon on admission
• Exclusion Criteria:
• • 1. Non-survivable burn injury determined by the admitting local burn surgeon on admission
• • 2. History of chronic renal failure requiring dialysis prior to injury
• • 3. History of developmental delay or congenital cognitive disorders
• • 4. Prior history of connective tissue disorders or autoimmune disease
• • 5. Anoxic or traumatic brain injury
• • 6. Prior history of cerebrovascular accident with residual mobility impairment
• • 7. Neurologic injury or disease-causing mobility impairment
• • 8. Prior history of leg amputation
• • 9. Non-viable leg requiring amputation on admission
• • 10. Anticipated inability to return for follow up testing after discharge
• • 11. History of a New York Heart Association (NYHA) class IV congestive heart failure