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Multicenter Benchmarking of Functional and Psychosocial Outcomes of Pediatric Burn Survivors
This study is currently recruiting participants.
Verified by Massachusetts General Hospital, October 2005
Sponsored by: Massachusetts General Hospital
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00239668
  Purpose

The purpose of this study is to establish an expected recovery trajectory (recovery model) in terms of physical and psychological function of the pediatric burn patient.


Condition
Burn

MedlinePlus related topics: Burns
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: Multicenter Benchmarking of Functional and Psychosocial Outcomes of Pediatric Burn Survivors

Further study details as provided by Massachusetts General Hospital:

Estimated Enrollment: 1200
Study Start Date: March 2000
Detailed Description:

The successful advancement of treatment for burns allows us now to save lives of children who sustain massive burn injuries. The purpose of this study is to establish an expected recovery trajectory (recovery model) in terms of the physical and psychological function for pediatric burn patients by assessing prospectively the outcomes of burn children who are treated at the four Shriners Hospitals for Children (SHC) burns hospitals. The study hopes to develop valid benchmarking of outcomes between the four hospitals and therefore, best practices will be utilized. This recovery trajectory will be used as a benchmark for functional and psychosocial outcomes following burn injury.

  • Participants in the study complete a series of self reporting questionnaires over a forty-eight month period. There are a total of nine time points during the forty-eight month commitment when questionnaires are given to parent and/or guardian and patients if they are 11 years or older.
  • Patients who undergo a reconstructive surgical procedure during their enrollment will fill a set of questionnaires related to the effects of the surgical procedure on their long-term recovery. The surgical procedure is not an intervention because of the study, it is part of their long-term follow-up care after their acute phase. There will be a pre-op and a six and twelve month post-op questionnaire.
  • The aim of this study is to develop an expected trajectory recovery model in terms of physical and psychological functioning. Analysis of the data using validated burn specific questionnaires will allow benchmarking of outcomes between the four Shriners Burns Hospitals. We aim to determine predictors of positive outcomes and focus on them as a standard of practice.
  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pediatric burn patients 18 years or less at time of injuries.
  • All high risk patients admitted for burn treatment with injuries >/= 20% total body surface area (tbsa), </= 20% tbsa to critical areas: hands, feet, face, and genitalia.
  • All low risk </= 20% to non critical areas.
  • Electrical, flame, scald, and chemical burns of at least a second degree nature.
  • English and Spanish speaking patients

Exclusion Criteria:

  • First degree burns
  • Patients admitted >30 days post acute injury.
  • Patients that speak a language other than English or Spanish.
  • Patients who decline to be in the study.
  • Patients with a non-burn injury
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239668

Contacts
Contact: Michelle I Hinson, RN 617-371-4809 mhinson@shrinenet.org

Locations
United States, California
Shriners Hospital for Children - Sacramento Recruiting
Sacramento, California, United States, 95817
Contact: Kate Nelson-Mooney, RN, BSN     916-453-2135     ksnelson@shrinenet.org    
Sub-Investigator: Tina Palmieri, MD            
Sub-Investigator: Kate Nelson-Mooney, RN, BSN            
United States, Massachusetts
Shriners Hospital for Children - Boston Recruiting
Boston, Massachusetts, United States, 02114
Contact: Janet L Gilroy-Lewis, RN, BSN     617-371-4708     jgilroy@shrinenet.org    
Sub-Investigator: Fredrick Stoddard, MD            
Sub-Investigator: Michelle I Hinson, RN            
Sub-Investigator: Janet Gilroy-Lewis, RN, BSN            
United States, Ohio
Shriners Hospital for Children - Cincinnati Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Theresa K Stubbs, RN     513-872-6062     kstubbs@shrinenet.org    
Sub-Investigator: Richard Kagan, MD            
Sub-Investigator: Angela Allen-Jackson, RN, MSN, MHA            
Sub-Investigator: Theresa K Stubbs, RN            
United States, Texas
Shriners Hospital for Children - Galveston Recruiting
Galveston, Texas, United States, 77550
Contact: Patricia Blakeney, Ph.D     409-770-6718     pblakeney@utmb.org    
Sub-Investigator: David N Herdon, MD            
Sub-Investigator: Robert McCauley, MD            
Sub-Investigator: Walter Meyer III, MD            
Sub-Investigator: Patricia Blakeney, Ph.D            
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Ronald G. Tompkins, MD, ScD MGH, Shriners Burn Hospital-Boston
  More Information

Study ID Numbers: 2001-P-000452/19
Study First Received: October 13, 2005
Last Updated: September 27, 2006
ClinicalTrials.gov Identifier: NCT00239668  
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Burns
Functional
Psychosocial
Recovery
Long-term
Pediatric
Surgical
Outcomes
Benchmarking

Study placed in the following topic categories:
Burns
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 14, 2009