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Wheeled Mobility for Preventing Pressure Ulcers (RCT-WC2)

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ClinicalTrials.gov Identifier: NCT01275313
Recruitment Status : Completed
First Posted : January 12, 2011
Results First Posted : June 9, 2017
Last Update Posted : June 9, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Mobility Limitation Device: Lightweight wheelchair Device: Skin Protection Cushion

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: RCT on Wheeled Mobility for Preventing Pressure Ulcers
Study Start Date : April 2011
Primary Completion Date : June 5, 2015
Study Completion Date : June 5, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Custom-Fitted Lightweight Wheelchair & Cushion
Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training
Device: Lightweight wheelchair
Seating and wheeled mobility assessment and fitting of a lightweight wheelchair
Cushion Only
Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair
Device: Skin Protection Cushion
Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion


Outcome Measures

Primary Outcome Measures :
  1. Incidence of a Sitting-induced Pressure Ulcer [ Time Frame: 182 days ]
    Skin assessments for incidence of sitting-induced pressure ulcer will occur once per week until occurrence of a pressure ulcer or 180 days


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275313


Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15206
Sponsors and Collaborators
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: David Brienza, PhD University of Pittsburgh
More Information

Publications:
Responsible Party: David Brienza, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01275313     History of Changes
Other Study ID Numbers: PRO09120362
R01HD041490 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2011    Key Record Dates
Results First Posted: June 9, 2017
Last Update Posted: June 9, 2017
Last Verified: May 2017

Keywords provided by David Brienza, University of Pittsburgh:
Pressure ulcers
wheelchairs
wheelchair functional capacity
custom-fitted wheelchair

Additional relevant MeSH terms:
Pressure Ulcer
Mobility Limitation
Skin Ulcer
Skin Diseases
Signs and Symptoms