NCT00239668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2000

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

12.8 years

First QC Date

October 13, 2005

Last Update Submit

March 5, 2019

Conditions

Keywords

BurnsFunctionalPsychosocialRecoveryLong-termPediatricSurgicalOutcomesBenchmarking

Eligibility Criteria

Age1 Day - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Shriners Hospital for Children - Sacramento

Sacramento, California, 95817, United States

Location

Shriners Hospital for Children - Boston

Boston, Massachusetts, 02114, United States

Location

Shriners Hospital for Children - Cincinnati

Cincinnati, Ohio, 45229, United States

Location

Shriners Hospital for Children - Galveston

Galveston, Texas, 77550, United States

Location

Related Publications (9)

  • Herndon DN, Voigt CD, Capek KD, Wurzer P, Guillory A, Kline A, Andersen CR, Klein GL, Tompkins RG, Suman OE, Finnerty CC, Meyer WJ, Sousse LE. Reversal of Growth Arrest With the Combined Administration of Oxandrolone and Propranolol in Severely Burned Children. Ann Surg. 2016 Sep;264(3):421-8. doi: 10.1097/SLA.0000000000001844.

  • Carey K, Kazis LE, Lee AF, Liang MH, Li NC, Hinson MI, Lydon MK, Bauk H, Shapiro GD, Tompkins RG; Multi-Center Benchmarking Study Working Group. Measuring the cost of care for children with acute burn injury. J Trauma Acute Care Surg. 2012 Sep;73(3 Suppl 2):S229-33. doi: 10.1097/TA.0b013e318265c88a.

  • Murphy JM, Kazis LE, Li NC, Lee AF, Hinson MI, White GW, Stoddard FJ, Palmieri TL, Meyer WJ 3rd, Liang MH, Tompkins RG; Multi-Center Benchmarking Study Working Group. Test performance characteristics of a case-finding psychosocial questionnaire for children with burn injuries and their families. J Trauma Acute Care Surg. 2012 Sep;73(3 Suppl 2):S221-8. doi: 10.1097/TA.0b013e318265c86b.

  • Meyer WJ 3rd, Lee AF, Kazis LE, Li NC, Sheridan RL, Herndon DN, Hinson MI, Stubbs TK, Kagan RJ, Palmieri TL, Tompkins RG; Multi-Center Benchmarking Study Working Group. Adolescent survivors of burn injuries and their parents' perceptions of recovery outcomes: do they agree or disagree? J Trauma Acute Care Surg. 2012 Sep;73(3 Suppl 2):S213-20. doi: 10.1097/TA.0b013e318265c843.

  • Palmieri TL, Nelson-Mooney K, Kagan RJ, Stubbs TK, Meyer WJ 3rd, Herndon DN, Hinson MI, Lee AF, Li NC, Kazis LE, Tompkins RG; Multi-Center Benchmarking Study Working Group. Impact of hand burns on health-related quality of life in children younger than 5 years. J Trauma Acute Care Surg. 2012 Sep;73(3 Suppl 2):S197-204. doi: 10.1097/TA.0b013e318265c7ff.

  • Warner P, Stubbs TK, Kagan RJ, Herndon DN, Palmieri TL, Kazis LE, Li NC, Lee AF, Meyer WJ 3rd, Tompkins RG; Multi-Center Benchmarking Study Working Group. The effects of facial burns on health outcomes in children aged 5 to 18 years. J Trauma Acute Care Surg. 2012 Sep;73(3 Suppl 2):S189-96. doi: 10.1097/TA.0b013e318265c7df.

  • Kazis LE, Lee AF, Hinson M, Liang MH, Rose MW, Palmieri TL, Meyer WJ 3rd, Kagan RJ, Li NC, Tompkins RG; Multi-Center Benchmarking Study Working Group. Methods for assessment of health outcomes in children with burn injury: the Multi-Center Benchmarking Study. J Trauma Acute Care Surg. 2012 Sep;73(3 Suppl 2):S179-88. doi: 10.1097/TA.0b013e318265c552.

  • Tompkins RG, Liang MH, Lee AF, Kazis LE; Multi-Center Benchmarking Study Working Group. The American Burn Association/Shriners Hospitals for Children Burn Outcomes Program: a progress report at 15 years. J Trauma Acute Care Surg. 2012 Sep;73(3 Suppl 2):S173-8. doi: 10.1097/TA.0b013e318265c53e.

  • Jeschke MG, Gauglitz GG, Kulp GA, Finnerty CC, Williams FN, Kraft R, Suman OE, Mlcak RP, Herndon DN. Long-term persistance of the pathophysiologic response to severe burn injury. PLoS One. 2011;6(7):e21245. doi: 10.1371/journal.pone.0021245. Epub 2011 Jul 18.

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Ronald G. Tompkins, MD, ScD

    MGH, Shriners Burn Hospital-Boston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

March 1, 2000

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

March 6, 2019

Record last verified: 2019-03

Locations