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Large Burn Outcome Study (LBO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
U.S. Department of Education
Shriners Hospitals for Children
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00731887
First received: July 30, 2008
Last updated: November 13, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Burns
 Procedure: Blood and urine testing

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas, Galveston:

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.


Estimated Enrollment: 160
Study Start Date: June 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731887

Locations
United States, Texas
Shriners Hospital for Children - Galveston
Galveston, Texas, United States, 77550
Sponsors and Collaborators
The University of Texas, Galveston
U.S. Department of Education
Shriners Hospitals for Children
Investigators
Principal Investigator: David N Herndon, MD University of Texas
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00731887     History of Changes
Other Study ID Numbers: 04-157B
Study First Received: July 30, 2008
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013