UnknownNot Applicable

STAT: Standard Therapy Plus Active Therapy

United States166 participantsStarted 2020-10-26

Plain-language summary

The objective of the study is to assess the efficacy of STAT, an activity-based therapy protocol compared to standard therapy (ST) to improve functional outcome and reduce disability in patients recovering from burn injury. This randomized multi-center trial is designed with two parallel treatment groups: STAT and ST. Efficacy of the STAT protocol will be determined through comparison to the ST only group. It will be conducted at seven burn centers.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 18 to 65 years old
✓. Total TBSA of 15% or greater with at least 10% TBSA of third-degree burn
✓. Potential need for a skin graft procedure determined by the local burn surgeon
✓. Survivable burn injury determined by the admitting local burn surgeon on admission

Exclusion criteria

✕. Non-survivable burn injury determined by the admitting local burn surgeon on admission
✕. History of chronic renal failure requiring dialysis prior to injury
✕. History of developmental delay or congenital cognitive disorders
✕. Prior history of connective tissue disorders or autoimmune disease
✕. Anoxic or traumatic brain injury
✕. Prior history of cerebrovascular accident with residual mobility impairment
✕. Neurologic injury or disease-causing mobility impairment
✕. Prior history of leg amputation

What they're measuring

Functional exercise capacity

Timeframe: 3 years

Trial details

NCT IDNCT04368117

SponsorAmerican Burn Association

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-01

Contact for this trial

Katrina Falwell, BSN RN

916-453-2134 kafalwell@ucdavis.edu

View on ClinicalTrials.gov More Burn Injury trials