CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 232 enrolled
Drug / intervention
Skin Protection Wheelchair Seat Cushion +1 moredevice
Likely dose
Not stated in record
Key inclusion· 5
  • Age 65 years or older
  • Wheelchair use exceeding 6 hours per day
  • No existing pressure ulcer on sitting surface
  • Braden score of 18 or less (indicating pressure ulcer risk)
Key exclusion· 4
  • Body weight exceeding 250 lbs
  • Hip width exceeding 20 inches
  • Does not meet all criteria of seating needs assessment
  • Current use of cushioning material or wheelchair superior to study devices

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00178126
NCT00178126N/ACompleted

An RCT on Preventing Pressure Ulcers With Seat Cushions

University of Pittsburgh·interventional·Posted Sep 15, 2005·Updated Jun 2, 2017

In Brief

A clinical study evaluating Skin Protection Wheelchair Seat Cushion and Segmented Foam Wheelchair Seat Cushion for Pressure Ulcer. Completed, enrolled 232 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPressure Ulcer
CountriesUnited States

Timeline

N/ACompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartMar 1, 2004
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 20.8 years ago

Interventions

Skin Protection Wheelchair Seat Cushiondevice

Cushion receiving CMS code for Skin Protection Wheelchair Cushion

Segmented Foam Wheelchair Seat Cushiondevice

General use class wheelchair seat cushion