Multicenter Benchmarking of Functional and Psychosocial Outcomes of Pediatric Burn Survivors

Burn Clinical Trial

Official title:

Multicenter Benchmarking of Functional and Psychosocial Outcomes of Pediatric Burn Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239668
• Other study ID #: 2001-P-000452/19
• Status: Completed
• Start date: March 2000
• Est. completion date: January 2013

Study information

• Verified date: March 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn
• Burns

Locations

Country	Name	City	State
United States	Shriners Hospital for Children - Boston	Boston	Massachusetts
United States	Shriners Hospital for Children - Cincinnati	Cincinnati	Ohio
United States	Shriners Hospital for Children - Galveston	Galveston	Texas
United States	Shriners Hospital for Children - Sacramento	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Shriners Hospitals for Children

Country where clinical trial is conducted

United States,