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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00771238 |
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Date of registration:
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10/10/2008 |
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Primary sponsor: |
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Public title:
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Pilot Study of Incidence and Change in Existing Pressure Ulcers: TC500 Bed Compared With Standard Beds
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Scientific title:
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A Pilot Study of Pressure Ulcer Incidence and Change in Existing Pressure Ulcers Comparing Subjects Placed on the TC500 Bed With Standard Beds in the 850-SICU Unit |
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Date of first enrolment:
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November 2008 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00771238 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Joyce Black, PhD, RN |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Nebraska |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Subjects admitted to the 850 Surgical ICU
2. Subjects or their legal reprehensive able to provide written consent for study
3. Subjects must be within the weight limits of the beds (70-500 lbs)
4. Subjects who do not require a specialty bed (subjective assessment by wound team)
5. Subjects are 19 years or older
Exclusion Criteria:
1. Subjects that do not wish to participate
2. Subjects thought to require a different mattress by current clinical bed protocols.
3. Subjects who require pulmonary clearance therapy delivered by a pulmonary mattress.
4. Subjects whose weight is outside of the limits of the bed system.
5. Subjects who have already completed 3 days of this study protocol and are considered
completed Subjects.
Age minimum:
19 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pressure Ulcers
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Intervention(s)
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Device: TC500
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Device: Total Care Treatment mattress
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Primary Outcome(s)
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Indicence of pressure ulcers
[Time Frame: at the end of study period (21 days)]
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Secondary Outcome(s)
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Compliance to skin care protocol
[Time Frame: End of Study]
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Cost of rental beds
[Time Frame: End of study]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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