Assessment of Mechanisms of Improved Wound Healing

Phase 2

Completed

Conditions: Burns

Interventions: Procedure: Stable Isotope Infusion study
Drug: IGF-1/IGFBP-3
Drug: Insulin High Dose
Drug: Itraconazole
Drug: Propranolol
Drug: Insulin Low Dose
Drug: Growth Hormone and Propranolol
Drug: Growth Hormone
Drug: Placebo or Control
Drug: Oxandrolone and Propranolol
Drug: oxandrolone

Registration Number: NCT00673309

Lead Sponsor: The University of Texas Medical Branch, Galveston

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 644

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IGF-1/IGFBP-3	IGF-1/IGFBP-3	IGF-1/IGFBP-3 will be administered until 95% wound healing
Growth Hormone	Stable Isotope Infusion study	Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue
Insulin High Dose	Insulin High Dose	Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue
Itraconazole	Stable Isotope Infusion study	Itraconazole will be administered until 95% wound healing.
Itraconazole	Itraconazole	Itraconazole will be administered until 95% wound healing.
Propranolol	Propranolol	Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
Insulin High Dose	Stable Isotope Infusion study	Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue
Oxandrolone	Stable Isotope Infusion study	Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
IGF-1/IGFBP-3	Stable Isotope Infusion study	IGF-1/IGFBP-3 will be administered until 95% wound healing
Insulin Low Dose	Insulin Low Dose	Insulin Low Dose will be administered until 95% wound healing.
Growth Hormone and Propranolol	Growth Hormone and Propranolol	Growth Hormone and Propranolol will be administered until 95% wound healing.
Growth Hormone	Growth Hormone	Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue
Propranolol	Stable Isotope Infusion study	Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue
Insulin Low Dose	Stable Isotope Infusion study	Insulin Low Dose will be administered until 95% wound healing.
Control/Placebo	Placebo or Control	Placebo or Control will be administered until 95% wound healing
Oxandrolone and Propranolol	Stable Isotope Infusion study	Oxandrolone and Propranolol will be administered until 95% wound healing
Oxandrolone and Propranolol	Oxandrolone and Propranolol	Oxandrolone and Propranolol will be administered until 95% wound healing
Control/Placebo	Stable Isotope Infusion study	Placebo or Control will be administered until 95% wound healing
Growth Hormone and Propranolol	Stable Isotope Infusion study	Growth Hormone and Propranolol will be administered until 95% wound healing.
Oxandrolone	oxandrolone	Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue

Primary Outcome Measures

Name	Time	Method
Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study	Admission to burn unit to 95% wound healing	At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.

Secondary Outcome Measures

Name	Time	Method
Incidence of Sepsis	Admission to burn unit to 95% wound healing	At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.
Improved Rate of Wound Healing	Admission to burn unit to 95% wound healing	At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.
Incidence of Morbidity and Mortality	Admission to burn unit to discharge	At the request of the study site, this study has been closed. Access to study-related data is unavailable, and the PI is no longer at the institution. Hence, we are unable to submit the results data. Although peer-reviewed articles have been located that reference NCT00673309, it is not clear and verifiable (without access to the actual study-related data) what the results for the study outcomes are.