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

Pressure Ulcers Clinical Trial

— P400  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139879
• Other study ID #: CR-0092
• Status: Completed
• Phase: N/A
• First received: June 7, 2010
• Last updated: November 16, 2015
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: November 2015
• Source: Hill-Rom
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers
• Ulcer

Intervention

Device:
• P400 mattress
The P400 mattress will be placed for a period of 12 weeks.

Locations

Country	Name	City	State
United States	Southwest Regional Wound Care Center	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Hill-Rom

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of New Ulcers	incidence of new ulcers while on the study surface	12 Weeks	No
Secondary	Healing Rate Per Week	The mean change in area per week for all ulcers	12 weeks	No