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| ID | Type | Description | Link |
|---|---|---|---|
| P50GM060338 | U.S. NIH Grant/Contract | View source | |
| R01GM056687 | U.S. NIH Grant/Contract | View source | |
| SHC #8660 | Other Grant/Funding Number | Shriners Hospital for children |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Growth Hormone | Experimental | Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue |
|
| Insulin High Dose | Experimental | Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue |
|
| Oxandrolone | Experimental | Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue |
|
| Propranolol | Experimental | Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue |
|
| IGF-1/IGFBP-3 | Experimental | IGF-1/IGFBP-3 will be administered until 95% wound healing |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David N. Herndon, MD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77550 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36656551 | Derived | Zinter MS, Markovic D, Asaro LA, Nadkarni VM, McQuillen PS, Sinha P, Matthay MA, Jeschke MG, Agus MSD, Sapru A; CAF-PINT Investigators of the PALISI Network. Tight Glycemic Control, Inflammation, and the ICU: Evidence for Heterogeneous Treatment Effects in Two Randomized Controlled Trials. Am J Respir Crit Care Med. 2023 Apr 1;207(7):945-949. doi: 10.1164/rccm.202210-1988LE. No abstract available. | |
| 23511841 | Derived | Kraft R, Herndon DN, Finnerty CC, Shahrokhi S, Jeschke MG. Occurrence of multiorgan dysfunction in pediatric burn patients: incidence and clinical outcome. Ann Surg. 2014 Feb;259(2):381-7. doi: 10.1097/SLA.0b013e31828c4d04. |
Not provided
Not provided
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.
Patients admitted to burn unit with >40% burn or greater
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Growth Hormone Administration | Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue 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) Growth Hormone: Recombinant Human Growth hormone to be administered daily until 95% wound healing. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
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| Insulin Low Dose | Experimental | Insulin Low Dose will be administered until 95% wound healing. |
|
| Itraconazole | Experimental | Itraconazole will be administered until 95% wound healing. |
|
| Growth Hormone and Propranolol | Experimental | Growth Hormone and Propranolol will be administered until 95% wound healing. |
|
| Oxandrolone and Propranolol | Experimental | Oxandrolone and Propranolol will be administered until 95% wound healing |
|
| Control/Placebo | Placebo Comparator | Placebo or Control will be administered until 95% wound healing |
|
| Insulin High Dose | Drug | Insulin IV administered continuously throughout hospitalization until wounds are 95% healed. |
|
|
| oxandrolone | Drug | Oxandrolone given daily throughout hospitalization until 95% wound healing. |
|
|
| 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. |
|
|
| Insulin Low Dose | Drug | Insulin administered IV until 95% wound healing |
|
|
| IGF-1/IGFBP-3 | Drug | Insulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing |
|
|
| Itraconazole | Drug | Itraconazole administered until 95% wound healing |
|
| Growth Hormone and Propranolol | Drug | Growth Hormone and Propranolol given until 95% wound healing |
|
|
| Oxandrolone and Propranolol | Drug | Oxandrolone and Propranolol |
|
| Placebo or Control | Drug | Administration of Placebo or Control until 95% wound healing |
|
| 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. | 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. | Admission to burn unit to 95% wound healing |
| 22606232 | Derived | Jeschke MG, Williams FN, Finnerty CC, Rodriguez NA, Kulp GA, Ferrando A, Norbury WB, Suman OE, Kraft R, Branski LK, Al-mousawi AM, Herndon DN. The effect of ketoconazole on post-burn inflammation, hypermetabolism and clinical outcomes. PLoS One. 2012;7(5):e35465. doi: 10.1371/journal.pone.0035465. Epub 2012 May 11. |
| 21789167 | Derived | Jeschke MG, Gauglitz GG, Kulp GA, Finnerty CC, Williams FN, Kraft R, Suman OE, Mlcak RP, Herndon DN. Long-term persistance of the pathophysiologic response to severe burn injury. PLoS One. 2011;6(7):e21245. doi: 10.1371/journal.pone.0021245. Epub 2011 Jul 18. |
| 20739853 | Derived | Jeschke MG, Kraft R, Emdad F, Kulp GA, Williams FN, Herndon DN. Glucose control in severely thermally injured pediatric patients: what glucose range should be the target? Ann Surg. 2010 Sep;252(3):521-7; discussion 527-8. doi: 10.1097/SLA.0b013e3181f2774c. |
| 20701787 | Derived | Mecott GA, Herndon DN, Kulp GA, Brooks NC, Al-Mousawi AM, Kraft R, Rivero HG, Williams FN, Branski LK, Jeschke MG. The use of exenatide in severely burned pediatric patients. Crit Care. 2010;14(4):R153. doi: 10.1186/cc9222. Epub 2010 Aug 11. |
| 20395554 | Derived | Jeschke MG, Kulp GA, Kraft R, Finnerty CC, Mlcak R, Lee JO, Herndon DN. Intensive insulin therapy in severely burned pediatric patients: a prospective randomized trial. Am J Respir Crit Care Med. 2010 Aug 1;182(3):351-9. doi: 10.1164/rccm.201002-0190OC. Epub 2010 Apr 15. |
| 19240154 | Derived | Gauglitz GG, Herndon DN, Kulp GA, Meyer WJ 3rd, Jeschke MG. Abnormal insulin sensitivity persists up to three years in pediatric patients post-burn. J Clin Endocrinol Metab. 2009 May;94(5):1656-64. doi: 10.1210/jc.2008-1947. Epub 2009 Feb 24. |
| 18791359 | Derived | Jeschke MG, Chinkes DL, Finnerty CC, Kulp G, Suman OE, Norbury WB, Branski LK, Gauglitz GG, Mlcak RP, Herndon DN. Pathophysiologic response to severe burn injury. Ann Surg. 2008 Sep;248(3):387-401. doi: 10.1097/SLA.0b013e3181856241. |
| FG001 | Insulin High Dose Administration | Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue 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) Insulin: Insulin IV administered continuously throughout hospitalization until wounds are 95% healed. |
| FG002 | Oxandrolone Administration | Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue 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) oxandrolone: Oxandrolone given daily throughout hospitalization until 95% wound healing. |
| FG003 | Propranolol Administration | Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue 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) Propranolol: Propranolol to be given daily throughout hospitalization until 95% wound healing. |
| FG004 | Itraconazole Administration | Itraconazole administered throughout hospitalization until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue 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) Itraconazole administered throughout hospitalization until 95% wound healing. |
| FG005 | IGF-1/IGFBP-3 Comparator | IGF-1/IGFBP-3 administered daily to 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue 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) IGF-1/IGFBP-3 administered until 95% wound healing |
| FG006 | Insulin Low Dose Administration | Insulin IV administered continuously through hospitalization to 95% wound healing. |
| FG007 | Growth Hormone and Propranolol Administration | Growth Hormone and Propranolol administration throughout hospitalization to 95% wound healing. Includes stable isotope infusion studies. |
| FG008 | Oxandrolone and Propranolol | Oxandrolone and Propranolol administration throughout hospitalization to 95% wound healing. Includes stable isotope infusion studies |
| FG009 | Control or Placebo | Control or Placebo administered through hospitalization to 95% wound healing. Includes stable isotope infusion studies. |
| COMPLETED |
|
| NOT COMPLETED |
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Growth Hormone Administration | Growth Hormone administered daily until 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue 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) Growth Hormone: Recombinant Human Growth hormone to be administered daily until 95% wound healing. |
| BG001 | Insulin High Dose Administration | Insulin IV administered continuously to 95% healing. Stable Isotope Infusion Study with collection of blood and tissue 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) Insulin: Insulin IV administered continuously throughout hospitalization until wounds are 95% healed. |
| BG002 | Oxandrolone Administration | Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue 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) oxandrolone: Oxandrolone given daily throughout hospitalization until 95% wound healing. |
| BG003 | Propranolol Administration | Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue 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) Propranolol: Propranolol to be given daily throughout hospitalization until 95% wound healing. |
| BG004 | Itraconazole Administration | Itraconazole administered throughout hospitalization until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue 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) Itraconazole administered throughout hospitalization until 95% wound healing. |
| BG005 | IGF-1/IGFBP-3 Comparator | IGF-1/IGFBP-3 administered daily to 95% wound healing. Stable Isotope Infusion Study with collection of blood and tissue 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) IGF-1/IGFBP-3 administered until 95% wound healing |
| BG006 | Insulin Low Dose Administration | Insulin IV administered continuously through hospitalization to 95% wound healing. |
| BG007 | Growth Hormone and Propranolol Administration | Growth Hormone and Propranolol administration throughout hospitalization to 95% wound healing. Includes stable isotope infusion studies. |
| BG008 | Oxandrolone and Propranolol | Oxandrolone and Propranolol administration throughout hospitalization to 95% wound healing. Includes stable isotope infusion studies |
| BG009 | Control or Placebo | Control or Placebo administered through hospitalization to 95% wound healing. Includes stable isotope infusion studies. |
| BG010 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | |||||||||||||||||||||
| Sex: Female, Male |
| ||||||||||||||||||||
| Protein Net Balance |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | 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. | 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. | Posted | 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. | 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. | Posted | 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. | 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. | Posted | 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.
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | unknown - Shriner's Burn Hospital revoked access to study-related data.. We are unable to submit the additional information or results-data. | 0 | 0 | 0 | 0 |
Not provided
Not provided
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.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tina Mack-Moshay- ClinicalTrials.gov Administrator | University of Texas Medical Branch | 409-266-6917 | tlmackmo@utmb.edu |
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D007328 | Insulin |
| D010074 | Oxandrolone |
| D009277 | Nandrolone |
| D011433 | Propranolol |
| D013006 | Growth Hormone |
| D000096764 | Insulin-Like Peptides |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004963 | Estrenes |
| D004962 | Estranes |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
Not provided
Not provided
| OG002 | Oxandrolone | Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue 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) oxandrolone: Oxandrolone given daily throughout hospitalization until 95% wound healing. |
| OG003 | Propranolol | Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue 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) Propranolol: Propranolol to be given daily throughout hospitalization until 95% wound healing. |
| OG004 | IGF-1/IGFBP-3 | IGF-1/IGFBP-3 will be administered until 95% wound healing 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) IGF-1/IGFBP-3: Insulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing |
| OG005 | Insulin Low Dose | Insulin Low Dose will be administered until 95% wound healing. 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) Insulin Low Dose: Insulin administered IV until 95% wound healing |
| OG006 | Itraconazole | Itraconazole will be administered until 95% wound healing. 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) Itraconazole: Itraconazole administered until 95% wound healing |
| OG007 | Growth Hormone and Propranolol | Growth Hormone and Propranolol will be administered until 95% wound healing. 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) Growth Hormone and Propranolol: Growth Hormone and Propranolol given until 95% wound healing |
| OG008 | Oxandrolone and Propranolol | Oxandrolone and Propranolol will be administered until 95% wound healing 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) Oxandrolone and Propranolol: Oxandrolone and Propranolol |
| OG009 | Control/Placebo | Placebo or Control will be administered until 95% wound healing 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) Placebo or Control: Administration of Placebo or Control until 95% wound healing |
|
| OG002 | Oxandrolone | Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue 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) oxandrolone: Oxandrolone given daily throughout hospitalization until 95% wound healing. |
| OG003 | Propranolol | Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue 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) Propranolol: Propranolol to be given daily throughout hospitalization until 95% wound healing. |
| OG004 | IGF-1/IGFBP-3 | IGF-1/IGFBP-3 will be administered until 95% wound healing 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) IGF-1/IGFBP-3: Insulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing |
| OG005 | Insulin Low Dose | Insulin Low Dose will be administered until 95% wound healing. 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) Insulin Low Dose: Insulin administered IV until 95% wound healing |
| OG006 | Itraconazole | Itraconazole will be administered until 95% wound healing. 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) Itraconazole: Itraconazole administered until 95% wound healing |
| OG007 | Growth Hormone and Propranolol | Growth Hormone and Propranolol will be administered until 95% wound healing. 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) Growth Hormone and Propranolol: Growth Hormone and Propranolol given until 95% wound healing |
| OG008 | Oxandrolone and Propranolol | Oxandrolone and Propranolol will be administered until 95% wound healing 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) Oxandrolone and Propranolol: Oxandrolone and Propranolol |
| OG009 | Control/Placebo | Placebo or Control will be administered until 95% wound healing 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) Placebo or Control: Administration of Placebo or Control until 95% wound healing |
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| OG002 | Oxandrolone | Oxandrolone administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue 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) oxandrolone: Oxandrolone given daily throughout hospitalization until 95% wound healing. |
| OG003 | Propranolol | Propranolol administered daily until 95% wound healing Stable Isotope Infusion Study with collection of blood and tissue 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) Propranolol: Propranolol to be given daily throughout hospitalization until 95% wound healing. |
| OG004 | IGF-1/IGFBP-3 | IGF-1/IGFBP-3 will be administered until 95% wound healing 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) IGF-1/IGFBP-3: Insulin Like Growth Factor-1/Insulin like Growth Factor Binding Protein 3 administered until 95% wound healing |
| OG005 | Insulin Low Dose | Insulin Low Dose will be administered until 95% wound healing. 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) Insulin Low Dose: Insulin administered IV until 95% wound healing |
| OG006 | Itraconazole | Itraconazole will be administered until 95% wound healing. 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) Itraconazole: Itraconazole administered until 95% wound healing |
| OG007 | Growth Hormone and Propranolol | Growth Hormone and Propranolol will be administered until 95% wound healing. 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) Growth Hormone and Propranolol: Growth Hormone and Propranolol given until 95% wound healing |
| OG008 | Oxandrolone and Propranolol | Oxandrolone and Propranolol will be administered until 95% wound healing 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) Oxandrolone and Propranolol: Oxandrolone and Propranolol |
| OG009 | Control/Placebo | Placebo or Control will be administered until 95% wound healing 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) Placebo or Control: Administration of Placebo or Control until 95% wound healing |
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