N/A
Completed N=258
Wheeled Mobility for Preventing Pressure Ulcers
Mobility Limitation
Source: ClinicalTrials.gov NCT01275313 ↗
Enrolled (actual)
258
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Incidence of a Sitting-induced Pressure Ulcer — 19; 15; 75; 69 Participants — p=0.77
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of a Sitting-induced Pressure Ulcer |
19; 15; 75; 69; 8; 5 | 0.77 |
Eligibility Criteria
Inclusion Criteria
- Male or female nursing home resident 60 years of age and older
- A Braden score of less than or equal to 18
- A combined Braden Activity and Mobility Subscale score less than or equal to 5
- Absence of ischial and sacral area pressure ulcers (see definition of pressure ulcer)
- A tolerance for total daily wheelchair sitting time of greater than or equal to 6 hours (not continuous)
- Ability to accommodate seating and positioning needs with the wheelchair selected for use in this study (Breezy Ultra 4)
- Informed written consent
Exclusion Criteria
- Body weight exceeding 250 lbs.
- Hip width exceeding 20 in.
- 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.
- 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)
- Current use of a HCPCS code K0004 wheelchair
Data sourced from ClinicalTrials.gov (NCT01275313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.