P400 for Stage II-IV Pressure Ulcers in Home and Extended Care
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Healing Rate [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]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.
- Incidence of new ulcers [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]incidence of new ulcers while on the study surface
- Patient Comfort [ Time Frame: 12 Week ] [ Designated as safety issue: No ]Patient comfort as assessed by a patient survey tool.
|Study Start Date:||June 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
All patients will receive the P400 mattress
Device: P400 mattress
The P400 mattress will be placed for a period of 12 weeks.
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.