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Completed

NCT Number: NCT00673309

Assessment of Mechanisms of Improved Wound Healing

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

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Key information

Conditions

Burns Wounds and Injuries

Age range

Up to 90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Texas Medical Branch

Galveston, Texas, 77550, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stable Isotope Infusion study

Procedure

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 Dose

Drug

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

Other names: Regular Insulin

Oxandrolone

Drug

Oxandrolone given daily throughout hospitalization until 95% wound healing.

Other names: nandrolone

Propranolol

Drug

Propranolol to be given daily throughout hospitalization until 95% wound healing.

growth hormone

Drug

Recombinant Human Growth hormone to be administered daily until 95% wound healing.

Other names: GH, rhGH, recombinant human Growth Hormone

Insulin Low Dose

Drug

Insulin administered IV until 95% wound healing

Other names: Insulin

IGF-1/IGFBP-3

Drug

Insulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing

Other names: Insulin Like Growth Factor

Itraconazole

Drug

Itraconazole administered until 95% wound healing

Growth Hormone and Propranolol

Drug

Growth Hormone and Propranolol given until 95% wound healing

Other names: GH and Propranolol

Oxandrolone and Propranolol

Drug

Oxandrolone and Propranolol

Placebo or Control

Drug

Administration of Placebo or Control until 95% wound healing

Primary outcomes

  1. Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study

    Time frame: 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 outcomes

  1. Improved Rate of Wound Healing

    Time frame: 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.

  2. Incidence of Morbidity and Mortality

    Time frame: 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.

  3. Incidence of Sepsis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2011
Study completion
2013
First posted
May 7, 2008
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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