Long Term Follow-Up of Burn Injuries | NCT00285636

Studies
Long Term Follow-Up of Burn Injuries

NCT00285636

Sponsor

National Institutes of Health (NIH)

Status

Completed

Last Update Posted

May 8, 2013Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Burn

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
97-4938-C08

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1992

Primary Completion Date

Sep 2007Actual

Completion Date

Sep 2008Actual

First Submitted Date

Jan 31, 2006

First Submission Date that Met QC Criteria

Jan 31, 2006

First Posted Date

Feb 2, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2013

Last Update Posted Date

May 8, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

David R. Patterson, Professor, National Institute of General Medical Sciences (NIGMS)Principal Investigator

Lead Sponsor

National Institutes of Health (NIH)NIH

Collaborators

Name	Class
U.S. Department of Education	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to investigate the psychological effects of burn injuries as experienced by patients.

Detailed Description

We are interested in determining how people adjust to burn injuries as a way of facilitating optimal recovery. This is done by conducting several questionnaires at the time of the discharge in the hospital, and later follow up with the patients up to two years.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with more than a 30% total surface area burn
English speaking

Exclusion Criteria:

Patients with less than a 30% total surface area burn
Non English speaking

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

burn patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David R. Patterson, Ph.D.	University of Washington	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Washington; Harborview Medical Center		Seattle	Washington	98104	United States