Phase 3
N=244
Assessment of Mechanisms of Improved Wound Healing
Burns
Bottom Line
View on ClinicalTrials.gov: NCT00673309 ↗Enrolled (actual)
244
Serious AEs
—
Results posted
Dec 2019
Primary outcome: Primary: Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Stable Isotope Infusion study (Procedure); Insulin High Dose (Drug); oxandrolone (Drug); Propranolol (Drug); Growth Hormone (Drug); Insulin Low Dose (Drug); IGF-1/IGFBP-3 (Drug); Itraconazole (Drug); Growth Hormone and Propranolol (Drug); Oxandrolone and Propranolol (Drug); Placebo or Control (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study |
— | — |
| SECONDARY Improved Rate of Wound Healing |
— | — |
| SECONDARY Incidence of Morbidity and Mortality |
— | — |
| SECONDARY Incidence of Sepsis |
— | — |
Summary
The purpose of this study is to find ways to improve wound healing and decrease the negative effects of trauma from burn injury.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00673309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.