STAT: Standard Therapy Plus Active Therapy

Running, not enrolling · Not applicable

Conditions studied: Burn Injury, Physical Injury, Thermal Burn

In brief

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.

Key facts

Study ID

NCT04368117

Run by

American Burn Association

People needed

166

Starts

2020-10-26

Expected to finish

2026-09-29

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Non-viable leg requiring amputation on admission
• Anticipated inability to return for follow up testing after discharge
• History of a New York Heart Association (NYHA) class IV congestive heart failure

Where it is running

• ValleyWise Health — Phoenix, Arizona, United States
• University of California Davis Medical Center-Regional Burn Center — Sacramento, California, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Health and Hospital Corporation dba Eskenazi Health — Indianapolis, Indiana, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• United States Army Institute of Surgical Research — Fort Sam Houston, Texas, United States

Full record on ClinicalTrials.gov

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