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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Pressure Ulcers

Intervention / Treatment
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* Device: P400 mattress


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has multiple Stage II pressure ulcers or at least one Stage III or IV pressure ulcer(s) (as per National Pressure Ulcer Advisory Panel Staging guidelines) located either on the trunk or pelvis (which would include trochanter and ischial ulcers ) having a clean wound bed of less than or equal to 25% necrotic tissue at the base of the pressure ulcer. Subjects may have heel ulcers, however these ulcers may not be considered a target study ulcer. Subject, or legally authorized representative is able to provide informed consent Subject weighs between 70 and 350 pounds Subject's nutritional status is thought to be adequate to support wound healing Subject qualifies for a Group 2 support surface (Target study ulcer must be at least 8 cm^2 in area to qualify) Exclusion Criteria: Subject's target ulcer is unstageable due to eschar or necrosis or a suspected Deep Tissue Injury may be located at the base of the wound. Subject has unresolved systemic infection, or pressure ulcer infection, or a history of osteomyelitis, or greater than 25% eschar or necrotic tissue present in the wound bed. Patient has already been enrolled in this study Patient has a recent history of non-compliance with pressure ulcer offloading, repositioning, or other areas of the treatment care plan, which would jeopardize wound healing if continued. Care plan goals are palliative

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P400 support surface<br>All patients will receive the P400 mattress | Device: P400 mattress<br>* The P400 mattress will be placed for a period of 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of New Ulcers | incidence of new ulcers while on the study surface | 12 Weeks | 
| Healing Rate Per Week | The mean change in area per week for all ulcers | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure Ulcer treatment Mattresses, Home Care, Extended Care, Wound measurements