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

This study has been completed.
Information provided by (Responsible Party):
Hill-Rom Identifier:
First received: June 7, 2010
Last updated: November 16, 2015
Last verified: November 2015
Results First Received: April 23, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pressure Ulcers
Intervention: Device: P400 mattress

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

All patients will receive the P400 mattress

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

Participant Flow:   Overall Study

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients with multiple Stage II or at least one Stage III or IV pressure ulcer having less than or equal to 25% necrotic tissue present in the pressure ulcer at the time of placement.

Reporting Groups

All patients will receive the P400 mattress

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

Baseline Measures
Overall Participants 
[units: participants]
[units: years]
Mean (Standard Deviation)
 64.9  (21.5) 
[units: participants]
Female   7 
Male   3 

  Outcome Measures
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1.  Primary:   Change From Baseline in Ulcer Surface Area at Week 12   [ Time Frame: 12 Weeks ]

2.  Secondary:   Incidence of New Ulcers   [ Time Frame: 12 Weeks ]

3.  Secondary:   Healing Rate Per Week   [ Time Frame: 12 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small study with no comparative arm.

  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Randy Wolcott
Organization: Wolcott and Associates
phone: 806-793-8869

Responsible Party: Hill-Rom 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