Clinical Trial: P400 for Stage II-IV Pressure Ulcers in Home and Extended Care

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Assessment of the Incidence and Treatment of Stage II -IV Pressure Ulcers in the Home Care or Extended Care Environments Utilizing the P400 Mattress

Brief Summary: To assess the efficacy of a pressure ulcer treatment mattress, the P400 mattress, in the treatment of multiple Stage II or one or more large Stage III or IV pressure ulcers in the home care and extended care (nursing home) environment.

Detailed Summary: Subjects will be recruited from those presenting to the wound clinic and meet the inclusion criteria. A total of 30 evaluable subjects will be recruited for this study from up to 2 wound care clinics /home health agencies (15 in Home Care and 15 in Extended Care). Subjects will be followed by weekly wound assessments for a period of 12 weeks or until their wounds heal. The outcome measurement is the rate of healing over the 12 week period.
Sponsor: Hill-Rom

Current Primary Outcome: Change From Baseline in Ulcer Surface Area at Week 12 [ Time Frame: 12 Weeks ]

The primary outcome measure for this study is to be healing rate by area, based on the identified target study ulcer.


Original Primary Outcome: Healing Rate [ Time Frame: 12 Weeks ]

The primary outcome measure for this study is to be healing rate by area, expressed as cm2 per week, and volume (cm3/week) based on the identified target study ulcer.


Current Secondary Outcome:

  • Incidence of New Ulcers [ Time Frame: 12 Weeks ]
    incidence of new ulcers while on the study surface
  • Healing Rate Per Week [ Time Frame: 12 weeks ]
    The mean change in area per week for all ulcers


Original Secondary Outcome:

  • Incidence of New Ulcers [ Time Frame: 12 Weeks ]
    incidence of new ulcers while on the study surface
  • Patient Comfort [ Time Frame: 12 weeks ]
    Patient comfort as assessed by a patient survey tool.


Information By: Hill-Rom

Dates:
Date Received: June 7, 2010
Date Started: June 2010
Date Completion:
Last Updated: November 16, 2015
Last Verified: November 2015