- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03038594
Growth Hormone Therapy for Muscle Regeneration in Severely Burned Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Either recombinant human growth hormone (daily subcutaneous injections of 0.05 mg/kg/day of GH at discharge [somatropin, Genotropin, Pfizer, New York, NY]; 0.025 mg/kg/day of GH titrated the week before discharge) or placebo (n=31) will be administered to adult burned subjects (n= 31, 18-85 years) after screening and voluntary consent who have ≥30% TBSA assessed by either the Lund and Browder chart or the 'rule of nines' method during excisional surgery. It will be administered daily for 9 months beginning the week before discharge, and the primary and secondary endpoints will be collected during the acute hospital stay, discharge, and long-term follow-up visits (6, 12, 18, and 24 months after burn injury). Additionally, subjects will be contacted frequently [most likely 1 week, 1 month, and 2 months post discharge by telephone] to ensure that there are no adverse events or concerns with their study drug, as well as visit with them during their clinical visits that address their post-burn needs. All subjects will receive similar standard medical care and treatment from the time of emergency admission until their discharge.
Growth hormone will be used to potentially attenuate losses in height, weight, muscle and bone, reverse the oxidative stress of burn injury and, in the process, decrease the secondary consequences of burn injury, including organ dysfunction. This may improve the quality of life of the burn patient by preventing pathophysiology that may result from muscle and bone loss and may reduce hospital stay. Our research will lay the foundation for the future development of effective, safe, and economic therapeutic interventions to treat burn injury-associated metabolic abnormalities. Also, it will provide the basis for the development of supplemental regulations and pharmacotherapy to treat burn patients with GH. The risks are very reasonable in relation to the anticipated benefits to our subjects because a) GH at a higher dose has been tested in pediatric burned subjects with minor adverse events, and b) the subjects will be monitored consistently.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Texas
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Galveston, Texas, United States, 77550-1220
- University of Texas Medical Branch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA
- 18-85 years old
- Over 30% total body surface area burn
- Provide consent and comprehend English or Spanish
EXCLUSION CRITERIA
- History of AIDS, AIDS-related complex, or HIV
- History of or current hepatitis B or C
- Pregnancy
- History of or Active Malignancy
- Insulin dependent diabetes mellitus type I prior to admission
- Insulin dependent diabetes mellitus type II (up to 12 months prior to admission)
- Other hyperglycemic disorders [not including transient post-burn/trauma hyperglycemia]
- Current oral corticosteroid treatment
- Currently participating in another interventional clinical trial at UTMB
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Growth Hormone
Daily subcutaneous injections of 0.05 mg/kg/day of Growth Hormone [somatropin, Genotropin, Pfizer, New York, NY] will be administered, from one week prior to discharge until 9 months post-burn.
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Other Names:
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PLACEBO_COMPARATOR: 0.09% saline solution
Daily subcutaneous injections of 0.09% of saline solution will be administered, from one week prior to discharge until 9 months post-burn.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lean body mass
Time Frame: At baseline
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Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
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At baseline
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Lean body mass
Time Frame: 6 months post burn-injury
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Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
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6 months post burn-injury
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Lean body mass
Time Frame: 12 months post burn-injury
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Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
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12 months post burn-injury
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Lean body mass
Time Frame: 18 months post burn-injury
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Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
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18 months post burn-injury
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Lean body mass
Time Frame: 24 months post burn-injury
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Dual-Energy X-ray Absorptiometry (DEXA) measured in grams
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24 months post burn-injury
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Muscle strength (peak torque)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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resistance testing muscle strength (assessed by Biodex isokinetic dynamometer)
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in Muscle strength ( total work)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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resistance testing muscle strength (Biodex isokinetic dynamometer)
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in Muscle strength (average power)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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resistance testing muscle strength (assessed by Biodex isokinetic dynamometer)
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in Muscle grip strength (maximum power)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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testing muscle strength (assessed by hand dynamometer)
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in Muscle endurance (maximum power)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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testing muscle endurance (assessed by Bruce treadmill test)
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in Resting energy expenditure (REE)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Indirect calorimetry
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in resting heart rate
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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electrocardiogram (EKG) readings
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in liver size
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Ultrasound readings
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in cardiac stroke volume
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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echocardiogram readings
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in cardiac output
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Echocardiogram readings
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in respiratory quotient
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Indirect calorimetry
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in Total body fat
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Dual-Energy X-ray Absorptiometry (DEXA)
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in percentage of total body fat
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Dual-Energy X-ray Absorptiometry (DEXA)
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in bone mineral content
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Dual-Energy X-ray Absorptiometry (DEXA)
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in bone mineral density
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Dual-Energy X-ray Absorptiometry (DEXA)
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in Maximal oxygen consumption
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Six-minute walk test
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in respiratory fatigue
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Six-minute walk test
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in leg fatigue
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Six-minute walk test
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in Muscle protein synthesis rate
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Deuterium water
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Hypertrophic scar development
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Vancouver Scar Scale
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in Forced vital capacity (FVC)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Pulmonary function test
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in forced expiratory volume in one second (FEV1)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Pulmonary function test
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in forced expiratory flow rate between 27-75% of the FVC (FEF25-75)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Pulmonary function test
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in FEV1/FVC ratio expressed as a percentage (FEV1/FVC%)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Pulmonary function test
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in vital capacity (VC)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Pulmonary function test
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in total lung capacity (TLC)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Pulmonary function test
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in residual volume (RV)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Pulmonary function test
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in functional residual capacity (FRC)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Pulmonary function test
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in lung diffusion capacity (DLCO)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Pulmonary function test
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in maximum voluntary ventilation (MVV)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Pulmonary function test
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in peak expiratory flow (PEF)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Pulmonary function test
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Change in Molecular biomarkers of oxidative and nitrosative stress (isoprostanes, asymmetric dimethylarginine)
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Urine analysis
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Changes in quality of life
Time Frame: Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Questionnaires
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Discharge (usually 30 days post burn) and 6, 12, 18, and 24 months after burn injury
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Collaborators and Investigators
Investigators
- Principal Investigator: Ludwik K Branski, MD, MMS, University of Texas
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-0298 / 15-0192
- W81XWH-15-1-0143 (OTHER_GRANT: US Department of Defense)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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