N/A N=232 Randomized Quadruple-blind Prevention

An RCT on Preventing Pressure Ulcers With Wheelchair Seat Cushions

Pressure Ulcer

Bottom Line

View on ClinicalTrials.gov: NCT00178126 ↗

Enrolled (actual)

232

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: Sitting-induced Pressure Ulcers — 8; 1 participants — p=0.04

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Skin Protection Wheelchair Seat Cushion (Device); Segmented Foam Wheelchair Seat Cushion (Device)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: University of Pittsburgh
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Sitting-induced Pressure Ulcers	8; 1	0.04 sig

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00178126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.