Back to resultsP400 for Stage II-IV Pressure Ulcers in Home and Extended Care (P400)
Primary Purpose
Pressure Ulcers
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
P400 mattress
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcers focused on measuring Pressure Ulcer treatment Mattresses, Home Care, Extended Care, Wound measurements
Eligibility Criteria
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
Sites / Locations
- Southwest Regional Wound Care Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
P400 support surface
Arm Description
All patients will receive the P400 mattress
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence of New Ulcers
incidence of new ulcers while on the study surface
Healing Rate Per Week
The mean change in area per week for all ulcers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01139879
Brief Title
P400 for Stage II-IV Pressure Ulcers in Home and Extended Care
Acronym
P400
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hill-Rom
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers
Keywords
Pressure Ulcer treatment Mattresses, Home Care, Extended Care, Wound measurements
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P400 support surface
Arm Type
Experimental
Arm Description
All patients will receive the P400 mattress
Intervention Type
Device
Intervention Name(s)
P400 mattress
Intervention Description
The P400 mattress will be placed for a period of 12 weeks.
Primary Outcome Measure Information:
Title
Change From Baseline in Ulcer Surface Area at Week 12
Description
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
Secondary Outcome Measure Information:
Title
Incidence of New Ulcers
Description
incidence of new ulcers while on the study surface
Time Frame
12 Weeks
Title
Healing Rate Per Week
Description
The mean change in area per week for all ulcers
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall Wolcott, MD
Organizational Affiliation
Randall Wolcott and Assoiciates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Regional Wound Care Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
12. IPD Sharing Statement
Learn more about this trial
P400 for Stage II-IV Pressure Ulcers in Home and Extended Care
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