Back to resultsEarly Detection of Pressure Induced Tissue Damage by Infrared Spectroscopy (ODP) Device
Primary Purpose
Pressure Ulcer Not Visible
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Infrared spectroscopy (ODP)
Sponsored by
About this trial
This is an interventional prevention trial for Pressure Ulcer Not Visible
Eligibility Criteria
Inclusion Criteria:
- Patients with stage 1 pressure injury
- Patients with high risk of developing pressure injury
Exclusion Criteria:
- Patients with stage 2 pressure injury or higher
Sites / Locations
- Rambam healrh care campus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Suspected pressure injury
Arm Description
Patients evaluated with high-risk for pressure injury
Outcomes
Primary Outcome Measures
Early detection of pressure induced tissue damage
Infrared spectroscopy will indicate on a system-defined scale (yes/no) whether or not the subject has a pressure injury
Pressure injury probability
Infrared spectroscopy will calculate using accepted statistical tools the probability of the subject getting a pressure injury within the next few days
Secondary Outcome Measures
Full Information
NCT ID
NCT03518190
First Posted
April 25, 2018
Last Updated
April 27, 2022
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT03518190
Brief Title
Early Detection of Pressure Induced Tissue Damage by Infrared Spectroscopy (ODP) Device
Official Title
Early Detection of Pressure Induced Tissue Damage by Infrared Spectroscopy (ODP) Device
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
May 12, 2021 (Actual)
Study Completion Date
May 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to demonstrate that infrared spectroscopy is able to detect pressure injuries at a very early stage
Detailed Description
During pressure injuries formation early sub dermal bio signal appear. By applying infrared spectroscopy at a suspicions injury site on the human body and obtaining a reflected infrared light infrared allows to determine early formation of a pressure injury/
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer Not Visible
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Suspected pressure injury
Arm Type
Experimental
Arm Description
Patients evaluated with high-risk for pressure injury
Intervention Type
Device
Intervention Name(s)
Infrared spectroscopy (ODP)
Intervention Description
Infrared spectroscopy device will be used to detect non-visible pressure injuries
Primary Outcome Measure Information:
Title
Early detection of pressure induced tissue damage
Description
Infrared spectroscopy will indicate on a system-defined scale (yes/no) whether or not the subject has a pressure injury
Time Frame
Ten minutes
Title
Pressure injury probability
Description
Infrared spectroscopy will calculate using accepted statistical tools the probability of the subject getting a pressure injury within the next few days
Time Frame
Ten minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with stage 1 pressure injury
Patients with high risk of developing pressure injury
Exclusion Criteria:
Patients with stage 2 pressure injury or higher
Facility Information:
Facility Name
Rambam healrh care campus
City
Haifa
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Detection of Pressure Induced Tissue Damage by Infrared Spectroscopy (ODP) Device
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