An RCT on Preventing Pressure Ulcers With Wheelchair Seat Cushions

Pressure Ulcer Clinical Trial

Official title:

An RCT on Preventing Pressure Ulcers With Seat Cushions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00178126
• Other study ID #: 0403061
• Secondary ID: R01HD041490
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: June 26, 2013
• Start date: March 2004
• Est. completion date: October 2008

Study information

• Verified date: June 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Device:
• Skin Protection Wheelchair Seat Cushion
Cushion receiving CMS code for Skin Protection Wheelchair Cushion
• Segmented Foam Wheelchair Seat Cushion
General use class wheelchair seat cushion

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sitting-induced Pressure Ulcers		6 months	No
Secondary	Relationship of Interface Pressure and pressure ulcer incidence		6 months	No