Trial on Wheeled Mobility for Preventing Pressure Ulcers
| Status: | Completed |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Orthopedic, Gastrointestinal |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Gastroenterology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2011 |
| End Date: | June 2015 |
RCT on Wheeled Mobility for Preventing Pressure Ulcers
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.
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.
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.
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.
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
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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University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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