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Large Burn Outcome Study (LBO)
This study is currently recruiting participants.
Verified by The University of Texas, Galveston, August 2008
Sponsors and Collaborators: The University of Texas, Galveston
National Institute of Disability and Rehabilitation Research
Shriners Hospitals for Children
Information provided by: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00731887
  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

MedlinePlus related topics: Anabolic Steroids Burns Rehabilitation
Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Insulin Vitamin A Retinol Thyroid hormones Thyroid Thromboplastin
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, 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

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

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

Blood and uring 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: July 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (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, IGF 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

Contacts
Contact: David N Herndon, MD 409-770-6731 dherndon@utmb.edu
Contact: Deb A Benjamin, RN, MSN 409-770-6731 dbenjami@utmb.edu

Locations
United States, Texas
Shriners Hospital for Children - Galveston Recruiting
Galveston, Texas, United States, 77550
Contact: Deb A Benjamin, RN, MSN     409-770-6731     dbenjami@utmb.edu    
Contact: Carole J Miller     409-770-6728     cmiller@utmb.edu    
Principal Investigator: David N Herndon, MD            
Sponsors and Collaborators
The University of Texas, Galveston
National Institute of Disability and Rehabilitation Research
Shriners Hospitals for Children
Investigators
Principal Investigator: David N Herndon, MD University of Texas
  More Information

Responsible Party: University of Texas Medical Branch ( David N. Herndon, MD/Principal Investigator )
Study ID Numbers: 04-157B
Study First Received: July 30, 2008
Last Updated: August 7, 2008
ClinicalTrials.gov Identifier: NCT00731887  
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Burns
Thrombin
Hydrocortisone
Cortisol succinate
Wounds and Injuries
Disorders of Environmental Origin
Hydroxycholecalciferols
Insulin
Retinol palmitate
Vitamin A
Thromboplastin
Zinc
Hydrocortisone acetate

ClinicalTrials.gov processed this record on January 16, 2009