Assessment of Mechanisms of Improved Wound Healing

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673309
• Other study ID #: 00-454
• Secondary ID: P50GM060338R01GM
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2000
• Est. completion date: April 2013

Study information

• Verified date: June 2023
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 644
• Est. completion date: April 2013
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

Procedure:
• Stable Isotope Infusion study
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)

Drug:
• Insulin High Dose
Insulin IV administered continuously throughout hospitalization until wounds are 95% healed.
• oxandrolone
Oxandrolone given daily throughout hospitalization until 95% wound healing.
• Propranolol
Propranolol to be given daily throughout hospitalization until 95% wound healing.
• Growth Hormone
Recombinant Human Growth hormone to be administered daily until 95% wound healing.
• Insulin Low Dose
Insulin administered IV until 95% wound healing
• IGF-1/IGFBP-3
Insulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing
• Itraconazole
Itraconazole administered until 95% wound healing
• Growth Hormone and Propranolol
Growth Hormone and Propranolol given until 95% wound healing
• Oxandrolone and Propranolol
Oxandrolone and Propranolol
• Placebo or Control
Administration of Placebo or Control until 95% wound healing

Locations

Country	Name	City	State
United States	University of Texas Medical Branch	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Admission to burn unit to 95% wound healing
Secondary	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.	Admission to burn unit to 95% wound healing
Secondary	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.	Admission to burn unit to discharge
Secondary	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.	Admission to burn unit to 95% wound healing