N/A
N=10
P400 for Stage II-IV Pressure Ulcers in Home and Extended Care
Pressure Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT01139879 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Change From Baseline in Ulcer Surface Area at Week 12 — -7.96 cm^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- P400 mattress (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hill-Rom
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Ulcer Surface Area at Week 12 |
-7.96 | — |
| SECONDARY Incidence of New Ulcers |
— | — |
| SECONDARY Healing Rate Per Week |
-0.92 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01139879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.