Status:
COMPLETED
P400 for Stage II-IV Pressure Ulcers in Home and Extended Care
Lead Sponsor:
Hill-Rom
Conditions:
Pressure Ulcers
Eligibility:
All Genders
18+ years
Phase:
NA
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 extend...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01139879
Start Date
June 1 2010
End Date
June 1 2011
Last Update
December 17 2015
Active Locations (1)
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1
Southwest Regional Wound Care Center
Lubbock, Texas, United States, 79410