NCT01161810

Brief Summary

This project will develop a descriptive database of patient information and patient outcomes. This database will be used to determine the association of time spent in rehabilitation and patient outcomes, to relate patient acuity to burn scar contracture development and to establish minimal time requirement guidelines for various rehabilitation patient outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
386

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Geographic Reach
1 country

14 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

July 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

3.8 years

First QC Date

July 12, 2010

Last Update Submit

August 2, 2023

Conditions

Keywords

BurnRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Measure patient outcome in terms of time devoted to rehabilitation

    Standard information that is recorded as part of daily routine in the rehabilitation treatment of patients with burn injury will be used as data to analyze patient outcomes

    At discharge

Study Arms (1)

Post-Burn Rehabilitation

Patients with an acute burn injury who are admitted to the hospital with anticipated length of stay of 5 days or greater

Other: Routine post burn rehabilitation therapy

Interventions

No testing outside of routine clinical rehabilitation will be performed

Post-Burn Rehabilitation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary diagnosis of acute burn injury

You may qualify if:

  • year of age or older
  • Admission for primary diagnosis of cutaneous burn injury
  • Anticipated length of stay equal to/greater than five days
  • \>2% deep partial thickness burn OR hand burn (which may be less than 2% deep partial thickness burn)

You may not qualify if:

  • Non-survivable burn as determined by the attending burn surgeon
  • Electrical burn injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Arizona Burn Center

Phoenix, Arizona, 85008, United States

Location

University of Califronia Irvine

Orange, California, 92868, United States

Location

University of California Davis, Regional Burn Center

Sacramento, California, 95817, United States

Location

Loyola University Health System

Maywood, Illinois, 60153, United States

Location

St. Joseph Regional Burn Center

Fort Wayne, Indiana, 46802, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Via Christi Regional Burn Center

Wichita, Kansas, 67214, United States

Location

Regions Hospital Burn Center

Saint Paul, Minnesota, 55101, United States

Location

St Elizabeth Regional Medical Center

Lincoln, Nebraska, 68510, United States

Location

NewYork-Presbyterian Weill Cornell Medical Center

New York, New York, 10065, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Oregon Burn Center, Legacy Emanuel Hospital & Health Center

Portland, Oregon, 97232, United States

Location

U.S. army Institute of Surgical Research

Fort Sam Houston, Texas, 78234-6315, United States

Location

University of Utah Health Services Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Reginald L Richard, MS, PT

    U.S. Army Institute of Surgical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2010

First Posted

July 14, 2010

Study Start

July 1, 2010

Primary Completion

April 1, 2014

Study Completion

September 1, 2014

Last Updated

August 4, 2023

Record last verified: 2023-08

Locations