STAT: Standard Therapy Plus Active Therapy

Description

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.

Conditions

Burn Injury, Physical Injury, Thermal Burn

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Study Overview

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Study Details

Study overview

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.

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

STAT: Standard Therapy Plus Active Therapy

Condition
Burn Injury
Intervention / Treatment

-

Contacts and Locations

Phoenix

ValleyWise Health, Phoenix, Arizona, United States, 85008

Sacramento

University of California Davis Medical Center-Regional Burn Center, Sacramento, California, United States, 95817

Maywood

Loyola University Medical Center, Maywood, Illinois, United States, 60153

Indianapolis

Health and Hospital Corporation dba Eskenazi Health, Indianapolis, Indiana, United States, 46202

Baltimore

Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States, 21224

Winston-Salem

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States, 27157

Fort Sam Houston

United States Army Institute of Surgical Research, Fort Sam Houston, Texas, United States, 78234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

American Burn Association,

Soman Sen, MD, PRINCIPAL_INVESTIGATOR, UC Davis

Study Record Dates

2025-09-30