Assessment of Mechanisms of Improved Wound Healing

Condition(s) targeted: Burns

Intervention: Collection of blood and tissues (Procedure); Stable Isotope Infusion study (Procedure); Radiology testing: DEXA, K+ counter, ultrasound, MRI (Procedure); IGF-1 (Drug); Insulin (Drug); oxandrolone (Drug); Propranolol (Drug); Clonidine (Drug); Ketoconazole (Drug); Dehydroepiandrosterone-sulfate (Drug); Fenofibrate (Drug); Metformin (Drug); Byetta (Drug); Growth Hormone (Drug); Pioglitazone (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: The University of Texas Medical Branch, Galveston

Official(s) and/or principal investigator(s):
David N. Herndon, MD, Principal Investigator, Affiliation: University of Texas

The purpose of this study is to find ways to improve wound healing and decrease the negative effects of trauma from burn injury.

Official title: Assessment of Mechanisms of Improved Wound Healing of Anabolic Agents and Diet in Severely Burned Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Decrease hypermetabolism as measured by stable isotope infusion study

Secondary outcome:

Improved rate of wound healing

Incidence of morbidity and mortality

Incidence of sepsis

Detailed description: This study involves research and the investigators hope to learn the following: how or what effect one or more anabolic ("tissue building") agents have on muscle metabolism, wound healing, and immune function after severe burn. The agents include the following: growth hormone, insulin-like growth factor-1 in combination with its binding proteins, insulin, Beta-adrenergic blockers, Alpha Adrenergic Agonist, anabolic steroids such as testosterone, Oxandrolone and nandrolone, ketoconazole and its derivatives, dehydroepiandrosterone, fenofibrate, diet or the application of skin substitute.

Minimum age: N/A. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patient is between 0 and 90 years of age

- Patient 18 years and older consents to participate in study protocol. If patient is

not able to consent, consent will be obtained from closest family member or legal guardian. Parental permission will be obtained for patients less than 18 years of age. Assent will be obtained from children 7-17 years of age if child is physically/mentally able to do so.

- greater than 30% TBSA burn requiring at least 1 operation with donor sites for skin

grafting Exclusion Criteria:

- Known history of AIDS, AIDS-related complex, Human Immunodeficiency Virus

- History of cancer within 5 years

- Tuberculosis, arthritis, cirrhosis, hyperlipidemia, bone or endocrine diseases,

autoimmune diseases

- Chronic glucocorticoid or non-steroidal anti-inflammatory drug therapy

University of Texas Medical Branch, Galveston, Texas 77550, United States

Starting date: July 2002
Last updated: May 4, 2012