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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The P400 mattress will be placed for a period of 12 weeks.
Southwest Regional Wound Care Center
Lubbock, Texas, United States
Change From Baseline in Ulcer Surface Area at Week 12
The primary outcome measure for this study is to be healing rate by area, based on the identified target study ulcer.
Time frame: 12 Weeks
Incidence of New Ulcers
incidence of new ulcers while on the study surface
Time frame: 12 Weeks
Healing Rate Per Week
The mean change in area per week for all ulcers
Time frame: 12 weeks
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