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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 28, 2006 | ||||||||
| Last Updated Date | July 1, 2008 | ||||||||
| Start Date ICMJE | June 2007 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00405795 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Envision® Surface Evaluation | ||||||||
| Official Title ICMJE | Envision® Surface Evaluation for Patients With Stage II, Stage III, or Stage IV Pressure Ulcers | ||||||||
| Brief Summary | This observational study will acquire initial clinical practice utilization and product safety data for the Envision® surface. |
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| Detailed Description | This is a single site, open label, observational study to acquire initial clinical practice utilization information, product safety, and wound healing data, as defined by changes in wound volume and/or surface area, for patients with pressure ulcers placed on this surface. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Cohort, Prospective | ||||||||
| Condition ICMJE | Pressure Ulcer | ||||||||
| Intervention ICMJE | Device: Envision® Patient Support System | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 30 | ||||||||
| Completion Date | March 2008 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | |||||||||
| 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 ID ICMJE | NCT00405795 | ||||||||
| Responsible Party | Gordon MacFarlane, PhD, Director Clinical Research, Hill-Rom | ||||||||
| Study ID Numbers ICMJE | MR-2005-083 | ||||||||
| Study Sponsor ICMJE | Hill-Rom | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Hill-Rom | ||||||||
| Verification Date | July 2008 | ||||||||
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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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