Multicenter Benchmarking of Functional and Psychosocial Outcomes of Pediatric Burn Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00239668
Recruitment Status : Unknown
Verified May 2012 by Ronald G. Tompkins, Massachusetts General Hospital.
Recruitment status was:  Recruiting
First Posted : October 17, 2005
Last Update Posted : May 3, 2012
Shriners Hospitals for Children
Information provided by (Responsible Party):
Ronald G. Tompkins, Massachusetts General Hospital

Brief Summary:
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 or disease

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.

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Benchmarking of Functional and Psychosocial Outcomes of Pediatric Burn Survivors
Study Start Date : March 2000
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients admitted to Shriners Hospitals-Boston,MA Cincinnati,OH, Galveston,TX and Sacramento, CA burn hospitals with a diagnosis of burn injury.

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 admitted to Shriners Hospital within 30 days of injury

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

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 identifier (NCT number): NCT00239668

Contact: Michelle I Hinson, RN,CCRN 617-371-4809
Contact: Martha K Lydon, RN,BSN 617-371-4808

United States, California
Shriners Hospital for Children - Sacramento Recruiting
Sacramento, California, United States, 95817
Contact: Lynda Painting, BS    916-453-2135   
Principal Investigator: Tina Palmieri, MD         
United States, Massachusetts
Shriners Hospital for Children - Boston Recruiting
Boston, Massachusetts, United States, 02114
Contact: Michelle I Hinson, RN    617-371-4809   
Contact: Martha Lydon, RN    617-371-4808   
Sub-Investigator: Fredrick Stoddard, MD         
Sub-Investigator: Michelle I Hinson, RN         
Sub-Investigator: Robert Sheridan, MD         
Sub-Investigator: Michael J Murphy, Ed.D.         
Sub-Investigator: Helena Bauk, RN         
United States, Ohio
Shriners Hospital for Children - Cincinnati Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Theresa K Stubbs, RN    513-872-6062   
Sub-Investigator: Richard Kagan, MD         
Principal Investigator: Theresa K Stubbs, RN         
Sub-Investigator: Petra Warner, MD         
United States, Texas
Shriners Hospital for Children - Galveston Recruiting
Galveston, Texas, United States, 77550
Contact: Kathryn Epperson, RN    409-770-6573   
Principal Investigator: David N Herndon, MD         
Sub-Investigator: Walter Meyer III, MD         
Sub-Investigator: Kathryn Epperson, RN         
Sponsors and Collaborators
Massachusetts General Hospital
Shriners Hospitals for Children
Principal Investigator: Ronald G. Tompkins, MD, ScD MGH, Shriners Burn Hospital-Boston

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Ronald G. Tompkins, Principal Investigator, Massachusetts General Hospital Identifier: NCT00239668     History of Changes
Other Study ID Numbers: 2001-P-000452/19
First Posted: October 17, 2005    Key Record Dates
Last Update Posted: May 3, 2012
Last Verified: May 2012

Keywords provided by Ronald G. Tompkins, Massachusetts General Hospital:

Additional relevant MeSH terms:
Wounds and Injuries