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Utility of Interface Pressure Mapping

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01439581
First Posted: September 23, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wellsense USA Inc.
Information provided by (Responsible Party):
Rob Behrendt, Henry Ford Health System
  Purpose
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.

Condition Intervention Phase
Ulcers Bedsores Device: Mapping System Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Rob Behrendt, Henry Ford Health System:

Primary Outcome Measures:
  • Pressure Mapping Reducing Hospital Acquired Pressure Ulcers [ Time Frame: Time admitted in the Medical Intensive Care Unit ]

Enrollment: 216
Study Start Date: August 2011
Study Completion Date: September 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients on mapping systems Device: Mapping System
Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
Active Comparator: Patients not on mapping systems Device: Mapping System
Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439581


Locations
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Wellsense USA Inc.
  More Information

Responsible Party: Rob Behrendt, MICU Unit Educator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01439581     History of Changes
Other Study ID Numbers: Interface Pressure Mapping
First Submitted: September 22, 2011
First Posted: September 23, 2011
Last Update Posted: October 12, 2017
Last Verified: March 2014

Keywords provided by Rob Behrendt, Henry Ford Health System:
patients
susceptible to
hospital
acquired pressure