Early Detection of Pressure Induced Tissue Damage by Infrared Spectroscopy (ODP) Device

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03518190
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : September 5, 2018
Information provided by (Responsible Party):
y_ullmann, Rambam Health Care Campus

Brief Summary:
The aim of this study is to demonstrate that infrared spectroscopy is able to detect pressure injuries at a very early stage

Condition or disease Intervention/treatment Phase
Pressure Ulcer Not Visible Device: Infrared spectroscopy (ODP) Not Applicable

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/

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Detection of Pressure Induced Tissue Damage by Infrared Spectroscopy (ODP) Device
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Arm Intervention/treatment
Experimental: Suspected pressure injury
Patients evaluated with high-risk for pressure injury
Device: Infrared spectroscopy (ODP)
Infrared spectroscopy device will be used to detect non-visible pressure injuries

Primary Outcome Measures :
  1. Early detection of pressure induced tissue damage [ Time Frame: Ten minutes ]
    Infrared spectroscopy will indicate on a system-defined scale (yes/no) whether or not the subject has a pressure injury

  2. Pressure injury probability [ Time Frame: Ten minutes ]
    Infrared spectroscopy will calculate using accepted statistical tools the probability of the subject getting a pressure injury within the next few days

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT03518190

Contact: Ronnie Klein 972-58-6972195

Rambam healrh care campus Recruiting
Haifa, Israel
Contact: Yehuda Ullmann    972-503312506   
Sponsors and Collaborators
Rambam Health Care Campus

Responsible Party: y_ullmann, Head of Plastic Surgery Department, Rambam Health Care Campus Identifier: NCT03518190     History of Changes
Other Study ID Numbers: 0039-18-RMB
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pressure Ulcer
Skin Ulcer
Skin Diseases