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

Tracking Information
First Received Date ^ICMJE	June 7, 2010
Last Updated Date	November 14, 2011
Start Date ^ICMJE	June 2010
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 8, 2010)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01139879 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 8, 2010)	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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	P400 for Stage II-IV Pressure Ulcers in Home and Extended Care
Official Title ^ICMJE	Assessment of the Incidence and Treatment of Stage II -IV Pressure Ulcers in the Home Care or Extended Care Environments Utilizing the P400 Mattress
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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Pressure Ulcers
Intervention ^ICMJE	Device: P400 mattress The P400 mattress will be placed for a period of 12 weeks.
Study Arm (s)	Experimental: P400 All patients will receive the P400 mattress Intervention: Device: P400 mattress
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	12
Completion Date	June 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. 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 cm2 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01139879
Other Study ID Numbers ^ICMJE	CR-0092
Has Data Monitoring Committee	No
Responsible Party	Hill-Rom
Study Sponsor ^ICMJE	Hill-Rom
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Hill-Rom
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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