NCT00673309 - Assessment of Mechanisms of Improved Wound Healing | Crick

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

644

Conditions

Burns

Interventions

Stable Isotope Infusion studyPROCEDURE

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)

Insulin High DoseDRUG

Insulin IV administered continuously throughout hospitalization until wounds are 95% healed.

oxandroloneDRUG

Oxandrolone given daily throughout hospitalization until 95% wound healing.

Eligibility

Sex: ALLMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Texas Medical Branch

Galveston, Texas, United States

Outcomes

Primary Outcomes

Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study

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.

Time frame: Admission to burn unit to 95% wound healing

Secondary Outcomes

Improved Rate of 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.

Time frame: Admission to burn unit to 95% wound healing

Incidence of Morbidity and Mortality

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.

Time frame: Admission to burn unit to discharge

Incidence of Sepsis

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.