Burn Injury Clinical Trial
Official title:
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
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.
This investigation is a multicenter trial involving severely burned patients. The design will be a 1:1 randomized control study comparing the rehabilitation intervention described below to current standard care in severely burned patients. This study will take place in multiple U.S. burn centers and involve adult (18 years and older) burn patient with ≥15% total body surface area (TBSA) burn who will undergo a skin graft procedure. The local burn surgeon will direct all medical and surgical treatment. The treating physician will make all clinical decisions regarding the patient. Study Groups Standard therapy (ST) group Patients in the ST group will receive routine burn therapy care with no specific prescription of activities or frequency/duration of therapy. Burn therapy will begin when the patient has been medically cleared by the treating physician to begin burn therapy and when the patient undergoes surgery, therapy will halt and resume as is typical for the participating site. All burn therapy procedures will be according to what is customary and typical for the burn center. Standard therapy practices will be documented with a pre-study interview with clinicians at each participating site. Standard burn therapy typically includes interventions such as range of motion, positioning, splinting, exercise, mobilization and pressure therapy. The amount of time and types of ST interventions will be documented at the end of each session daily. Any missed or interrupted treatment time will also be documented. Post discharge home program will include what would normally be included at discharge. Active therapy (STAT) intervention group Patients randomized to receive STAT therapy will receive an intensive, quantifiable, activity-based protocol emphasizing four of the most active components of therapy: mobilization, strength training, aerobic training and functional training. The STAT protocol guidelines are described below. As with the ST group, STAT therapy will begin when the patient has been medically cleared by the treating physician to begin burn therapy. STAT will not be provided for any given therapy session that the patient demonstrates any of the contraindicated safety parameters defined in Table 2. When the patient undergoes surgery, the STAT protocol will be held for the day of surgery and will resume post-operative day #1 whenever possible. The STAT protocol will be implemented 30-45 minutes per day, 5 days/ per week when possible throughout the patient's care from admission until the patient is discharged from acute care with a target treatment minimum of 150 minutes per week. Over the course of a week, all four activities in the STAT protocol should be implemented when possible. Multiple activities can be addressed within one session or single activities over multiple days. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT02241941 -
Evaluation of Single-dose Pharmacokinetics of Intravenous Daptomycin in Patients With Thermal Injury
|
Phase 4 | |
Completed |
NCT02210208 -
A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.
|
N/A | |
Completed |
NCT05063409 -
Transfusion Ratio of Fresh Frozen Plasma (FFP) to Packed Red Blood Cell (PRBC) During Burn Excision and Grafting
|
N/A | |
Completed |
NCT03730688 -
Non-invasive Limb Compartment Pressure Measurement
|
N/A | |
Terminated |
NCT01773083 -
Trial of Nebulized Heparin Versus Placebo for Inhalation Trauma
|
Phase 3 | |
Completed |
NCT02092701 -
Effects of Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period
|
N/A | |
Recruiting |
NCT06263296 -
Smartphone Assisted Self-management Education for Adult Burn Patient at Aftercare
|
N/A | |
Completed |
NCT02145130 -
Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects
|
Phase 1 | |
Completed |
NCT01618630 -
Amino Acid Supplementation in Recovery From Severe Burns
|
N/A | |
Recruiting |
NCT05876442 -
Efficacy of EPSW Plus HILT on Carpal Tunnel Syndrome Post Burn Injury
|
N/A | |
Completed |
NCT04417439 -
The Effect of Acute Phase Treatment Approaches on Creatine Kinase and the Musculoskeletal System in Different Types of Burns
|
||
Completed |
NCT02417818 -
Cutaneous Microcirculation After Plasma Therapy
|
N/A | |
Completed |
NCT02417805 -
Cutaneous Microcirculation After Remote Ischemic Preconditioning
|
N/A | |
Completed |
NCT02417779 -
Cutaneous Microcirculation After Extracorporeal Shock Wave Therapy
|
N/A | |
Completed |
NCT01404026 -
Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Due to Burn Injury
|
N/A | |
Completed |
NCT03204669 -
Trace Element Repletion Following Severe Burn Injury
|
N/A | |
Recruiting |
NCT04947449 -
Potential Benefits of Laser Treatment on Skin Blood Flow and Sweating in Burn Survivors
|
||
Not yet recruiting |
NCT05532488 -
Inulin in Burn-induced Insulin Resistance
|
N/A | |
Recruiting |
NCT02189538 -
Effect of n-3 PUFA From Fish in Enteral Nutrition of Major Burn Patients
|
N/A | |
Completed |
NCT01795079 -
Effects of Transcranial Direct Current Stimulation (tDCS) on Neuropathic Symptoms Following Burn Injury
|
N/A |