Phase 3
Completed N=244
Assessment of Mechanisms of Improved Wound Healing
Burns
Source: ClinicalTrials.gov NCT00673309 ↗
Enrolled (actual)
244
Serious AEs
—
Results posted
Dec 2019
Primary outcomePrimary: Decrease Hypermetabolism as Measured by Stable Isotope Infusion Study
◆ Published Evidence
Highly cited
627citations · ~42 / year
Long-term persistance of the pathophysiologic response to severe burn injury.
Summary
The purpose of this study is to find ways to improve wound healing and decrease the negative effects of trauma from burn injury.
Linked Publications (5)
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Long-term persistance of the pathophysiologic response to severe burn injury.
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Glucose control in severely thermally injured pediatric patients: what glucose range should be the target?
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Occurrence of multiorgan dysfunction in pediatric burn patients: incidence and clinical outcome.
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The effect of ketoconazole on post-burn inflammation, hypermetabolism and clinical outcomes.
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Tight Glycemic Control, Inflammation, and the ICU: Evidence for Heterogeneous Treatment Effects in Two Randomized Controlled Trials.
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 |
— | — |
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) and the linked publication. 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. Informational only — not medical advice.