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

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

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.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcers
• Intervention / Treatment: Device: P400 mattress

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79410
      • Southwest Regional Wound Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hill-Rom
• Investigators: Principal Investigator: Randall Wolcott, MD, Randall Wolcott and Assoiciates

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 7, 2010
• First Submitted That Met QC Criteria: June 8, 2010
• First Posted (Estimate): June 9, 2010

Study Record Updates

• Last Update Posted (Estimate): December 17, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Pressure Ulcer treatment Mattresses; Home Care; Extended Care; Wound measurements
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: CR-0092

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No