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
  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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Sitting-induced 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 ]

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:
  • ROHO, Quadtro
  • Sunrise Medical, Jay2 Deep Contour
  • Invacare, Infinity

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
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

Publications:
Responsible Party: David Brienza, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00178126     History of Changes
Other Study ID Numbers: 0403061, R01HD041490
Study First Received: September 13, 2005
Last Updated: June 26, 2013
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 August 18, 2014