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

Not Applicable

Completed

• Conditions: Pressure Ulcers
• Interventions: Device: P400 mattress

• Registration Number: NCT01139879
• Lead Sponsor: Hill-Rom

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-07
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-09
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2015-04-23
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-16
• Last Update Submitted: 2015-11-16
• Results First Posted: 2015-12-17
• Last Update Posted: 2015-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. 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.
2. Subjects may have heel ulcers, however these ulcers may not be considered a target study ulcer.
3. Subject, or legally authorized representative is able to provide informed consent
4. Subject weighs between 70 and 350 pounds
5. Subject's nutritional status is thought to be adequate to support wound healing
6. Subject qualifies for a Group 2 support surface (Target study ulcer must be at least 8 cm^2 in area to qualify)

Exclusion Criteria

1. 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.
2. 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.
3. Patient has already been enrolled in this study
4. 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.
5. Care plan goals are palliative

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
P400 support surface	P400 mattress	All patients will receive the P400 mattress

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Ulcer Surface Area at Week 12	12 Weeks	The primary outcome measure for this study is to be healing rate by area, based on the identified target study ulcer.

Secondary Outcome Measures

Name	Time	Method
Healing Rate Per Week	12 weeks	The mean change in area per week for all ulcers
Incidence of New Ulcers	12 Weeks	incidence of new ulcers while on the study surface

Trial Locations

Locations (1)

Southwest Regional Wound Care Center; 🇺🇸 Lubbock, Texas, United States