The Relationship of Rehabilitation Therapy Time To The Prevention of Burn Scar Contracture (ACT)
This study is enrolling participants by invitation only.
Sponsor:
American Burn Association
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
American Burn Association
ClinicalTrials.gov Identifier:
NCT01161810
First received: July 12, 2010
Last updated: January 30, 2013
Last verified: January 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 12, 2010 | ||||
| Last Updated Date | January 30, 2013 | ||||
| Start Date ICMJE | July 2010 | ||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Measure patient outcome in terms of time devoted to rehabilitation [ Time Frame: At discharge ] [ Designated as safety issue: No ] 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 |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01161810 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Relationship of Rehabilitation Therapy Time To The Prevention of Burn Scar Contracture | ||||
| Official Title ICMJE | Burn Patient Acuity Demographics, Scar Contractures and Rehabilitation Treatment Time Related to Patient Outcomes (ACT) | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Primary diagnosis of acute burn injury |
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| Condition ICMJE | Burns | ||||
| Intervention ICMJE | Other: Routine post burn rehabilitation therapy
No testing outside of routine clinical rehabilitation will be performed |
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| Study Group/Cohort (s) | 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
Intervention: Other: Routine post burn rehabilitation therapy |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 600 | ||||
| Estimated Completion Date | September 2014 | ||||
| Estimated Primary Completion Date | September 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01161810 | ||||
| Other Study ID Numbers ICMJE | ABA-MCTG-0003, H-08-028 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | American Burn Association | ||||
| Study Sponsor ICMJE | American Burn Association | ||||
| Collaborators ICMJE | U.S. Army Medical Research and Materiel Command | ||||
| Investigators ICMJE |
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| Information Provided By | American Burn Association | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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