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Completed

NCT Number: NCT01275313

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15206, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lightweight wheelchair

Device

Seating and wheeled mobility assessment and fitting of a lightweight wheelchair

Skin Protection Cushion

Device

Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion

Primary outcomes

  1. Incidence of a Sitting-induced Pressure Ulcer

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

RCT on Wheeled Mobility for Preventing Pressure Ulcers

Acronym: RCT-WC2

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 12, 2011
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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