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Utility of Interface Pressure Mapping

This study has been completed.
Sponsor:
Collaborator:
Wellsense USA Inc
Information provided by (Responsible Party):
Rob Behrendt, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01439581
First received: September 22, 2011
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Pressure Mapping Reducing Hospital Acquired Pressure Ulcers [ Time Frame: Time admitted in the Medical Intensive Care Unit ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 22, 2011
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013