NCT00178126

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
8.7 years until next milestone

Results Posted

Study results publicly available

June 2, 2017

Completed
Last Updated

June 2, 2017

Status Verified

April 1, 2017

Enrollment Period

4.6 years

First QC Date

September 13, 2005

Results QC Date

October 11, 2016

Last Update Submit

April 28, 2017

Conditions

Pressure Ulcer

Keywords

pressure ulcer

Outcome Measures

Primary Outcomes (1)

  • Sitting-induced Pressure Ulcers

    6 months

Study Arms (2)

Segmented Foam Cushion

ACTIVE COMPARATOR

Receive seating assessment, wheelchair and seat cushion representing the standard of care in nursing homes

Device: Segmented Foam Wheelchair Seat Cushion

Skin Protection Cushion

EXPERIMENTAL

Receive seating assessment, wheelchair and cushion meeting CMS code for Skin Protection Wheelchair Cushion

Device: Skin Protection Wheelchair Seat Cushion

Interventions

Skin Protection Wheelchair Seat CushionDEVICE

Cushion receiving CMS code for Skin Protection Wheelchair Cushion

Also known as: ROHO, Quadtro, Sunrise Medical, Jay2 Deep Contour, Invacare, Infinity
Skin Protection Cushion
Segmented Foam Wheelchair Seat CushionDEVICE

General use class wheelchair seat cushion

Segmented Foam Cushion

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related 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.1532-5415.2010.03168.x. Epub 2010 Nov 10.

    PMID: 21070197RESULT

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
David Brienza
Organization
University of PIttsburgh
DBrienza@pitt.edu
(412) 624-6383

Study Officials

  • David M Brienza, Ph.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

  • Sheryl Kelsey, Ph.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

March 1, 2004

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

June 2, 2017

Results First Posted

June 2, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)