Wheeled Mobility for Preventing Pressure Ulcers

Not Applicable

Completed

• Conditions: Mobility Limitation
• Interventions: Device: Lightweight wheelchair; Device: Skin Protection Cushion

• Registration Number: NCT01275313
• Lead Sponsor: University of Pittsburgh

Brief 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.

Study Timeline

• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-11
• Study First Posted: 2011-01-12
• Study Start: 2011-04
• Primary Completion: 2015-06-05
• Study Completion: 2015-06-05
• Results First Submitted: 2017-05-23
• Results First Submitted QC: 2017-05-23
• Results First Posted: 2017-06-09
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-02
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

1. Male or female nursing home resident 60 years of age and older
2. A Braden score of less than or equal to 18
3. A combined Braden Activity and Mobility Subscale score less than or equal to 5
4. Absence of ischial and sacral area pressure ulcers (see definition of pressure ulcer)
5. A tolerance for total daily wheelchair sitting time of greater than or equal to 6 hours (not continuous)
6. Ability to accommodate seating and positioning needs with the wheelchair selected for use in this study (Breezy Ultra 4)
7. Informed written consent

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Exclusion Criteria

1. Body weight exceeding 250 lbs.
2. Hip width exceeding 20 in.
3. Wheelchair seating requirements for additional head support, seat depth > 20 inches, elevated leg rests or severe orthopedic deformities of the pelvis, lower extremities or back that exceed the accommodating capability of the Breezy Ultra 4 wheelchair.
4. Current use of any cushioning material(s) other than a standard cushion, a folded pad, or a pillow (standard cushion as defined by HCPCS code for Standard Cushions, i.e., non-skin protection cushion)
5. Current use of a HCPCS code K0004 wheelchair

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Custom-Fitted Lightweight Wheelchair & Cushion	Lightweight wheelchair	Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training
Cushion Only	Skin Protection Cushion	Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair

Primary Outcome Measures

Name	Time	Method
Incidence of a Sitting-induced Pressure Ulcer	182 days	Skin assessments for incidence of sitting-induced pressure ulcers will occur once per week until the occurrence of a pressure ulcer or 182 days

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States