An RCT on Preventing Pressure Ulcers With Wheelchair Seat Cushions
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|ClinicalTrials.gov Identifier: NCT00178126|
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : June 2, 2017
Last Update Posted : June 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcer||Device: Skin Protection Wheelchair Seat Cushion Device: Segmented Foam Wheelchair Seat Cushion||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||232 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||An RCT on Preventing Pressure Ulcers With Seat Cushions|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
Active Comparator: 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
- Sitting-induced Pressure Ulcers [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178126
|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|