An RCT on Preventing Pressure Ulcers With Wheelchair Seat Cushions
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Purpose
The primary aim of the proposed multi-site, randomized pressure-reducing wheelchair trial (PRWC-II) is to determine the efficacy of pressure-reducing cushions in preventing sitting-acquired pressure ulcers in the elderly, nursing home population. Positive results of the proposed trial will provide the level of evidence needed to change the standard of care to include the routine evaluation of at-risk residents for seating and positioning needs and the provision of pressure-reducing cushions as a preventive measure against sitting-acquired pressure ulcers. If our hypothesis is valid, such intervention should result in a decrease in the incidence and prevalence of sitting-acquired pressure ulcers, reduced healthcare costs, and improved quality of life.
| Condition | Intervention | Phase |
|---|---|---|
|
Pressure Ulcer |
Device: Skin Protection Wheelchair Seat Cushion Device: Segmented Foam Wheelchair Seat Cushion |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | An RCT on Preventing Pressure Ulcers With Seat Cushions |
- Sitting-induced Pressure Ulcers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Relationship of Interface Pressure and pressure ulcer incidence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 232 |
| Study Start Date: | March 2004 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Segmented Foam Cushion
Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes
|
Device: Segmented Foam Wheelchair Seat Cushion
General use class wheelchair seat cushion
|
|
Experimental: Skin Protection Cushion
Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion
|
Device: Skin Protection Wheelchair Seat Cushion
Cushion receiving CMS code for Skin Protection Wheelchair Cushion
Other Names:
|
Detailed Description:
Pressure ulcers (aka pressure sores, bed sores and decubitus ulcers) are a significant healthcare problem for the growing number of United States elderly long-term care (LTC) residents. Pressure ulcers (PU) diminish quality of life, exact a devastating loss of function, increase the risk of death in geriatric populations and raise healthcare costs.
Despite Federal preventive mandates for the long-term care (LTC) setting, widespread non-compliance occurs. The last three Centers for Medicare and Medicaid Services (CMS) LTC surveys showed a cumulative increase of 21% in the number of citations issued for failure to provide proper intervention to prevent or treat pressure ulcers. Costs for the management of PU in the US likely exceed $6.4 billion annually with a prevalence of approximately 28% in the LTC population.
Estimates of the number of sitting-acquired PU in the elderly, at-risk population range from 36-50%. Several studies, including our own pilot investigation, support these estimates and have suggested that the use of wheelchair cushions designed to reduce interface pressure will reduce the incidence of sitting-acquired PU. Despite this evidence, elderly wheelchair users are not routinely evaluated for seating and positioning needs as definitive studies have not been completed to justify funding for such seating interventions. Consequently, elderly Medicare beneficiaries are being denied access to medically necessary and clinically appropriate interventions and instead are most frequently provided with convoluted or segmented-foam cushions that are not designed for pressure ulcer prevention.
The primary aim of the proposed multi-site, randomized pressure-reducing wheelchair trial (PRWC-II) is to determine the efficacy of pressure-reducing cushions in preventing sitting-acquired pressure ulcers in the elderly, nursing home population. Positive results of the proposed trial will provide the level of evidence needed to change the standard of care to include the routine evaluation of at-risk residents for seating and positioning needs and the provision of pressure-reducing cushions as a preventive measure against sitting-acquired pressure ulcers. If our hypothesis is valid, such intervention should result in a decrease in the incidence and prevalence of sitting-acquired pressure ulcers, reduced healthcare costs, and improved quality of life.
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 65 and older
- use wheelchair > 6 hours per day
- no pressure ulcer on sitting surface
- Braden score of 18 or less
- combined activity and mobility Braden sub-score of 5 or less
Exclusion Criteria:
- Body Weight exceeds 250 lbs.
- Hip Width exceeds 20 inches
- does not meet all criteria of seating needs assessment
- current use of cushioning material or wheelchair better than study devices
Contacts and Locations| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15260 | |
| Principal Investigator: | David M Brienza, Ph.D. | University of Pittsburgh |
| Principal Investigator: | Sheryl Kelsey, Ph.D. | University of Pittsburgh |
More Information
Publications:
| Responsible Party: | David Brienza, University of PIttsburgh |
| ClinicalTrials.gov Identifier: | NCT00178126 History of Changes |
| Other Study ID Numbers: | 0403061, R01HD041490 |
| Study First Received: | September 13, 2005 |
| Last Updated: | January 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Pittsburgh:
|
pressure ulcer |
Additional relevant MeSH terms:
|
Pressure Ulcer Ulcer Skin Ulcer Skin Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013