Comparing standard therapy to an activity-based therapy for burn recovery
STAT: Standard Therapy Plus Active Therapy to Improve Mobility, Long-Term Activity, and Quality of Life for Severely Burn Injured Patients After Skin Graft Surgery
This study is testing if a new activity-based therapy helps adults recovering from severe burns do better and feel less disabled compared to standard burn care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | American Burn Association Academic / other |
| Locations | 7 sites (Phoenix, Arizona and 6 other locations) |
| Trial ID | NCT04368117 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of an activity-based therapy protocol, known as STAT, against standard therapy in improving functional outcomes and reducing disability in patients recovering from burn injuries. It is a randomized, multicenter trial involving adult patients with severe burns who are undergoing skin graft procedures. Participants will be assigned to either the STAT group, which receives structured activity therapy, or the standard therapy group, which follows routine burn care without specific activity prescriptions. The study will take place across multiple burn centers in the U.S.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with severe burns covering 15% or more of their total body surface area, including significant third-degree burns.
Not a fit: Patients with non-survivable burn injuries or significant pre-existing medical conditions that impair mobility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery outcomes and reduced disability for patients with severe burn injuries.
How similar studies have performed: While the approach of using activity-based therapy is promising, the specific efficacy of the STAT protocol compared to standard therapy has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Phoenix, Arizona and 6 other locations
- ValleyWise Health — Phoenix, Arizona, United States (Recruiting)
- University of California Davis Medical Center-Regional Burn Center — Sacramento, California, United States (Recruiting)
- Loyola University Medical Center — Maywood, Illinois, United States (Recruiting)
- Health and Hospital Corporation dba Eskenazi Health — Indianapolis, Indiana, United States (Recruiting)
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (Recruiting)
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
- United States Army Institute of Surgical Research — Fort Sam Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Soman Sen, MD — UC Davis
- Study coordinator: Katrina Falwell, BSN RN
- Email: kafalwell@ucdavis.edu
- Phone: 916-453-2134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.