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An RCT on Preventing Pressure Ulcers With Wheelchair Seat Cushions

NCT00178126 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2017-06-02

Study results available
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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.

Conditions

  • Pressure Ulcer

Interventions

DEVICE

Skin Protection Wheelchair Seat Cushion

Cushion receiving CMS code for Skin Protection Wheelchair Cushion

DEVICE

Segmented Foam Wheelchair Seat Cushion

General use class wheelchair seat cushion

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • David M Brienza, Ph.D. · University of Pittsburgh

  • Sheryl Kelsey, Ph.D. · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00178126 on ClinicalTrials.gov