An RCT on Preventing Pressure Ulcers With Wheelchair Seat Cushions

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Brienza, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00178126
First received: September 13, 2005
Last updated: June 26, 2013
Last verified: June 2013

September 13, 2005
June 26, 2013
March 2004
October 2008   (final data collection date for primary outcome measure)
Sitting-induced Pressure Ulcers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Prevention of Pressure Ulcers
Complete list of historical versions of study NCT00178126 on ClinicalTrials.gov Archive Site
Relationship of Interface Pressure and pressure ulcer incidence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Relationship of Interface Pressure and pressure ulcer incidence
Not Provided
Not Provided
 
An RCT on Preventing Pressure Ulcers With Wheelchair Seat Cushions
An RCT on Preventing Pressure Ulcers With Seat Cushions

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pressure Ulcer
  • Device: Skin Protection Wheelchair Seat Cushion
    Cushion receiving CMS code for Skin Protection Wheelchair Cushion
    Other Names:
    • ROHO, Quadtro
    • Sunrise Medical, Jay2 Deep Contour
    • Invacare, Infinity
  • Device: Segmented Foam Wheelchair Seat Cushion
    General use class wheelchair seat cushion
  • Segmented Foam Cushion
    Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes
    Intervention: Device: Segmented Foam Wheelchair Seat Cushion
  • Experimental: Skin Protection Cushion
    Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion
    Intervention: Device: Skin Protection Wheelchair Seat Cushion
Brienza D, Kelsey S, Karg P, Allegretti A, Olson M, Schmeler M, Zanca J, Geyer MJ, Kusturiss M, Holm M. A randomized clinical trial on preventing pressure ulcers with wheelchair seat cushions. J Am Geriatr Soc. 2010 Dec;58(12):2308-14. doi: 10.1111/j.1532-5415.2010.03168.x. Epub 2010 Nov 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
232
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00178126
0403061, R01HD041490
No
David Brienza, University of Pittsburgh
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: David M Brienza, Ph.D. University of Pittsburgh
Principal Investigator: Sheryl Kelsey, Ph.D. University of Pittsburgh
University of Pittsburgh
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP