N/A
N=52
Pilot Study of Incidence and Change in Existing Pressure Ulcers: TC500 Bed Compared With Standard Beds
Pressure Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT00771238 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Indicence of Pressure Ulcers — 0; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- P500 Mattress (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Hill-Rom
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Indicence of Pressure Ulcers |
0; 4 | — |
| SECONDARY Cost of Rental Beds |
0; 4116 | — |
Summary
This pilot study will compare the incidence of pressure ulcers and the change in existing pressure ulcers for patients who are either placed on the new TC500 bed against those placed on the standard ICU bed in the Cardiovascular unit of University of Nebraska Medical Center. Additionally, the cost associated with rental beds will be calculated as well as skin care compliance. Sixty patients will be enrolled (30 per study arm).
Eligibility Criteria
Inclusion Criteria
- Subjects admitted to the 850 Surgical ICU
- Subjects or their legal reprehensive able to provide written consent for study
- Subjects must be within the weight limits of the beds (70-500 lbs)
- Subjects who do not require a specialty bed (subjective assessment by wound team)
- Subjects are 19 years or older
Exclusion Criteria
- Subjects that do not wish to participate
- Subjects thought to require a different mattress by current clinical bed protocols.
- Subjects who require pulmonary clearance therapy delivered by a pulmonary mattress.
- Subjects whose weight is outside of the limits of the bed system.
- Subjects who have already completed 3 days of this study protocol and are considered completed Subjects.
Data sourced from ClinicalTrials.gov (NCT00771238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.