Wheeled Mobility for Preventing Pressure Ulcers

Mobility Limitation Clinical Trial

— RCT-WC2  

Official title:

RCT on Wheeled Mobility for Preventing Pressure Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01275313
• Other study ID #: PRO09120362
• Secondary ID: R01HD041490
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: June 5, 2015

Study information

• Verified date: June 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: June 5, 2015
• Est. primary completion date: June 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mobility Limitation
• Pressure Ulcer

Intervention

Device:
• Lightweight wheelchair
Seating and wheeled mobility assessment and fitting of a lightweight wheelchair
• Skin Protection Cushion
Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of a Sitting-induced Pressure Ulcer	Skin assessments for incidence of sitting-induced pressure ulcers will occur once per week until the occurrence of a pressure ulcer or 182 days	182 days