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An RCT on Preventing Pressure Ulcers With Wheelchair Seat Cushions
This study is currently recruiting participants.
Verified by University of Pittsburgh, June 2008
Sponsors and Collaborators: University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00178126
  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: Wheelchair Seat Cushion
Phase II

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: An RCT on Preventing Pressure Ulcers With Seat Cushions

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Prevention of Pressure Ulcers [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship of Interface Pressure and pressure ulcer incidence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: March 2004
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: Sham Comparator
General use class wheelchair seat cushion
Device: Wheelchair Seat Cushion
Wheelchair Seat Cushion

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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00178126

Contacts
Contact: Margo B Holm, Ph.D. 412 383-6615 mholm@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: David M Brienza, Ph.D.     412-586-6907     dbrienza@pitt.edu    
Contact: Margo B Holm, Ph.D.     412 383-6515     dbrienza@pitt.edu    
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: David M Brienza, Ph.D. University of Pittsburgh
Principal Investigator: Sheryl Kelsey, Ph.D. University of Pittsburgh
  More Information

Responsible Party: University of PIttsburgh ( David Brienza )
Study ID Numbers: 1 R01HD04109
Study First Received: September 13, 2005
Last Updated: June 4, 2008
ClinicalTrials.gov Identifier: NCT00178126  
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
pressure ulcer

Study placed in the following topic categories:
Skin Diseases
Ulcer
Skin Ulcer
Pressure Ulcer

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009