Clinical trial NCT00673309
Conditions: Burns
Keywords: burns
Sponsor: The University of Texas Medical Branch, Galveston
Start date: 2000-07-01; Completion date: 2013-04-01
Enrollment: 644 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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

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.

Arms: arm 1: Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue arm 2: Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue arm 3: Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue arm 4: Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue arm 5: IGF-1/IGFBP-3 will be administered until 95% wound healing arm 6: Insulin Low Dose will be administered until 95% wound healing. arm 7: Itraconazole will be administered until 95% wound healing. arm 8: Growth Hormone and Propranolol will be administered until 95% wound healing. arm 9: Oxandrolone and Propranolol will be administered until 95% wound healing arm 10: Placebo or Control will be administered until 95% wound healing
Interventions: intervention 1: Stable Isotope Infusion study intervention 2: Insulin High Dose intervention 3: oxandrolone intervention 4: Propranolol intervention 5: Growth Hormone intervention 6: Insulin Low Dose intervention 7: IGF-1/IGFBP-3 intervention 8: Itraconazole intervention 9: Growth Hormone and Propranolol intervention 10: Oxandrolone and Propranolol intervention 11: Placebo or Control
Intervention descriptions: intervention 1: Stable isotope infusion study to be done following each surgery. Tagged isotopes to assess uptake into blood and tissues. Includes collection of blood and tissues (muscle) intervention 2: Insulin IV administered continuously throughout hospitalization until wounds are 95% healed. intervention 3: Oxandrolone given daily throughout hospitalization until 95% wound healing. intervention 4: Propranolol to be given daily throughout hospitalization until 95% wound healing. intervention 5: Recombinant Human Growth hormone to be administered daily until 95% wound healing. intervention 6: Insulin administered IV until 95% wound healing intervention 7: Insulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing intervention 8: Itraconazole administered until 95% wound healing intervention 9: Growth Hormone and Propranolol given until 95% wound healing intervention 10: Oxandrolone and Propranolol intervention 11: Administration of Placebo or Control until 95% wound healing

Protocol documents: