NCT01139879

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Hill-Rom · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pressure Ulcers

Interventions

Type	Name	Description
DEVICE	P400 mattress	The P400 mattress will be placed for a period of 12 weeks.

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-06-09
• Last updated: 2015-12-17
• Results posted: 2015-12-17

Locations

1 site across 1 country: United States