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Large Burn Outcome Study (LBO)

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ClinicalTrials.gov Identifier: NCT00731887
Recruitment Status : Withdrawn (Personnel involved in this protocol are no longer associated with this study)
First Posted : August 11, 2008
Last Update Posted : January 8, 2014
Sponsor:
Collaborators:
U.S. Department of Education
Shriners Hospitals for Children
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Brief Summary:
To examine long term physical and psychosocial outcomes of pediatric burn survivors. We want to learn about thoughts, feelings, coping style, social support, and overall adjustment following burn injury.

Condition or disease Intervention/treatment
Burns Procedure: Blood and urine testing

Detailed Description:
To evaluate the long term quality of life of adolescents and adults who suffered severe pediatric burns. This study will include an array of physical and psychosocial assessments, thus providing a unique and complete set of information on the long term outcomes in this population.

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assessment of the Treatment of the Severely Burned With Anabolic Agents on Improved Wound Healing, Recovery and Rehabilitation: Large Burn Outcome Study
Study Start Date : June 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources


Intervention Details:
    Procedure: Blood and urine testing
    complete blood count, routine chemistries, liver function test, retinol binding protein, transferrin, prothrombin time, partial thromboplastin time, fibrinogen, Vitamin A and Zinc, Insulin Growth Factor levels and binding proteins, cytokines (interleukins 1, 6, 12), insulin, thyroid hormones, cortisol, 25-hydroxyvitamin D, and osteocalcin.


Biospecimen Retention:   Samples Without DNA
Blood and urine collected for this study will be retained for possible re-analysis if needed for the duration of the study.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Those that have received a burn injury at least 3 years ago and that recieved acute burn treatment at Shriners Hospital for Children - Galveston between 1986-2005.
Criteria

Inclusion Criteria:

  • At least 60% third degree total body surface area
  • Acute burn treatment at Shriners Burns Hospital for Children - Galveston between 1986-2005
  • Three years post injury
  • Current age of at least 16 years

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731887


Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
U.S. Department of Education
Shriners Hospitals for Children
Investigators
Principal Investigator: David N Herndon, MD University of Texas

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00731887     History of Changes
Other Study ID Numbers: 04-157B
First Posted: August 11, 2008    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: December 2013

Keywords provided by The University of Texas Medical Branch, Galveston:
Burn injury
Burn recovery

Additional relevant MeSH terms:
Burns
Wounds and Injuries