Utility of Interface Pressure Mapping

Ulcers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01439581
• Other study ID #: Interface Pressure Mapping
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: September 2012

Study information

• Verified date: September 2019
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: September 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bedsores
• Pressure Ulcer
• Ulcers

Intervention

Device:
• Mapping System
Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
• Non-Mapping System
Standard ICU bed with no mapping system

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	Wellsense USA Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure Mapping Reducing Hospital Acquired Pressure Ulcers	Comparing number of pressure ulcers when using pressure mapping compared to when not.	Time admitted in the Medical Intensive Care Unit