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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hill-Rom
ClinicalTrials.gov Identifier:
NCT01139879
First received: June 7, 2010
Last updated: November 16, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention
Pressure Ulcers
Device: P400 mattress

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hill-Rom:

Primary Outcome Measures:
  • Change From Baseline in Ulcer Surface Area at Week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    incidence of new ulcers while on the study surface

  • Healing Rate Per Week [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The mean change in area per week for all ulcers


Enrollment: 10
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139879

Locations
United States, Texas
Southwest Regional Wound Care Center
Lubbock, Texas, United States, 79410
Sponsors and Collaborators
Hill-Rom
Investigators
Principal Investigator: Randall Wolcott, MD Randall Wolcott and Assoiciates
  More Information

Responsible Party: Hill-Rom
ClinicalTrials.gov Identifier: NCT01139879     History of Changes
Other Study ID Numbers: CR-0092 
Study First Received: June 7, 2010
Results First Received: April 23, 2015
Last Updated: November 16, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Hill-Rom:
Pressure Ulcer treatment Mattresses
Home Care
Extended Care
Wound measurements

Additional relevant MeSH terms:
Ulcer
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on September 26, 2016