Back to resultsUtility of Interface Pressure Mapping
Primary Purpose
Ulcers, Bedsores
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mapping System
Non-Mapping System
Sponsored by
About this trial
This is an interventional prevention trial for Ulcers focused on measuring patients, susceptible to, hospital, acquired pressure
Eligibility Criteria
Inclusion Criteria:
- 18 years and older,
- care giver trained on mapping system
Exclusion Criteria:
- Less than 18 years,
- pregnant women,
- weight greater 550 lbs, and subjects requiring a specialty mattress
Sites / Locations
- Henry Ford Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients on mapping systems
Patients not on mapping systems
Arm Description
Outcomes
Primary Outcome Measures
Pressure Mapping Reducing Hospital Acquired Pressure Ulcers
Comparing number of pressure ulcers when using pressure mapping compared to when not.
Secondary Outcome Measures
Full Information
NCT ID
NCT01439581
First Posted
September 22, 2011
Last Updated
September 10, 2019
Sponsor
Henry Ford Health System
Collaborators
Wellsense USA Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01439581
Brief Title
Utility of Interface Pressure Mapping
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
Wellsense USA Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine if a device that measures and displays pressure that the patients feel when in bed can help nurses reposition the patient effectively and thereby reduce bedsores in the intensive care unit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcers, Bedsores
Keywords
patients, susceptible to, hospital, acquired pressure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were assigned randomly to either a medical intensive care unit with pressure mapping beds or a unit that did not have them
Masking
None (Open Label)
Allocation
Randomized
Enrollment
428 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients on mapping systems
Arm Type
Experimental
Arm Title
Patients not on mapping systems
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Mapping System
Intervention Description
Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
Intervention Type
Device
Intervention Name(s)
Non-Mapping System
Intervention Description
Standard ICU bed with no mapping system
Primary Outcome Measure Information:
Title
Pressure Mapping Reducing Hospital Acquired Pressure Ulcers
Description
Comparing number of pressure ulcers when using pressure mapping compared to when not.
Time Frame
Time admitted in the Medical Intensive Care Unit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years and older,
care giver trained on mapping system
Exclusion Criteria:
Less than 18 years,
pregnant women,
weight greater 550 lbs, and subjects requiring a specialty mattress
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
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Utility of Interface Pressure Mapping
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