Clinical Trials Directory

Trials / Completed

CompletedNCT01275313

Wheeled Mobility for Preventing Pressure Ulcers

RCT on Wheeled Mobility for Preventing Pressure Ulcers

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
258 (actual)
Sponsor
University of Pittsburgh · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Not accepted

Summary

The proposed clinical trial is aimed at demonstrating the important role wheelchairs play in preventing pressure ulcers (bed sores). Although most pressure ulcers can be prevented, they are common in nursing home settings because their causes are difficult to identify. This clinical trial will guide practitioners toward improving preventive care practices by demonstrating how to effectively apply wheelchair and seat cushion technology.

Detailed description

Pressure ulcers are a significant healthcare problem for the growing number of nursing home residents in the United States and around the world. Pressure ulcers diminish quality of life, exact a devastating loss of function, increase the risk of death in geriatric populations and raise healthcare costs. Costs for the management of pressure ulcers in the US likely exceeds $6.4 billion annually, with a prevalence of approximately 12% in the high risk LTC population. A previous clinical trial at the University of Pittsburgh studied the effects of seat cushions on pressure ulcer incidence and found that when a skin protection seat cushion is used with a properly fitted wheelchair there is a significant reduction in incidence. The data led the investigators to question whether having a properly fitted wheelchair also has a significant effect on pressure ulcer incidence. This clinical trial investigate this question by randomizing subjects into a control group that receives a skin protection cushion and wheelchair training for use in their facility supplied wheelchair, or a treatment group that receives a skin protection cushion, wheelchair training and a new custom-fitted wheelchair. We expect that the treatment group will have a lower incidence of pressure ulcers.

Conditions

Interventions

TypeNameDescription
DEVICELightweight wheelchairSeating and wheeled mobility assessment and fitting of a lightweight wheelchair
DEVICESkin Protection CushionSeating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion

Timeline

Start date
2011-04-01
Primary completion
2015-06-05
Completion
2015-06-05
First posted
2011-01-12
Last updated
2022-06-28
Results posted
2017-06-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01275313. Inclusion in this directory is not an endorsement.