Text Size

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

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 14, 2011
Last verified: November 2011
History of Changes
  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:

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Further study details as provided by Hill-Rom:

Primary Outcome Measures:
  • Healing Rate [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    The primary outcome measure for this study is to be healing rate by area, expressed as cm2 per week, and volume (cm3/week) 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

  • Patient Comfort [ Time Frame: 12 Week ] [ Designated as safety issue: No ]
    Patient comfort as assessed by a patient survey tool.


Enrollment: 12
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
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
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 NPUAP 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 cm2 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
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
  More Information

No publications provided

Responsible Party: Hill-Rom
ClinicalTrials.gov Identifier: NCT01139879     History of Changes
Other Study ID Numbers: CR-0092
Study First Received: June 7, 2010
Last Updated: November 14, 2011
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:
Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013