Galveston, Texas 77551


Purpose:

The purpose of the program is to study and characterize the outcome of burn injury with particular attention to improving the rehabilitation of burn survivors, including children. Various agents are assessed for effectiveness on long term burn outcome, such as growth hormone, oxandrolone, propranolol,ketoconazole, inhospital exercise and home exercise.


Study summary:

The University of Texas Medical Branch(UTMB) project improves outcomes for severely burned children by instituting and evaluating two modifications to traditional rehabilitation: (1) an intensive rehabilitation program including active resistance exercise; (2) long term administration of anabolic agents. Effectiveness is assessed by comparison with functional outcomes achieved in traditional outpatient rehabilitation programs. Results indicate improvement in strength, endurance and bone density with these modifications. The project also maintains a longitudinal database that includes measures of cardiopulmonary function, growth and maturation, bone density, range of motion, and psychosocial adjustment.


Criteria:

Inclusion Criteria: - Burn 30% Total Body Surface Area (TBSA) or greater - Ages 0-80 yrs - Negative pregnancy test - Informed consent Exclusion Criteria: - Untreated malignancy, known history of AIDS, ARC, HIV - Recent history of myocardial infarction (6 wks) - Tuberculosis, arthritis, cirrhosis, hyperlipidemia, bone or endocrine diseases, autoimmune diseases - Chronic glucocorticoid or non steroidal anti inflammatory drug therapy - Diabetes mellitus prior to burn injury - Renal insufficiency (defined by creatinine >3.0 mg/dl) - Hepatic disease (bilirubin > 3.0 mg/dl)


NCT ID:

NCT00675714


Primary Contact:

Study Director
David N Herndon, MD
University of Texas

David N Herndon, MD
Phone: 409-770-6731
Email: dherndon@utmb.edu


Backup Contact:

Email: ca2reed@utmb.edu
Cathy L Reed, BSN
Phone: 409-770-6987


Location Contact:

Galveston, Texas 77551
United States

David N Herndon, MD
Phone: 409-770-6731
Email: dherndon@utmb.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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