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

Pressure Ulcer Not Visible Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518190
• Other study ID #: 0039-18-RMB
• Status: Completed
• Phase: N/A
• Start date: July 30, 2018
• Est. completion date: May 12, 2021

Study information

• Verified date: April 2022
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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/

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 12, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcer Not Visible

Intervention

Device:
• Infrared spectroscopy (ODP)
Infrared spectroscopy device will be used to detect non-visible pressure injuries

Locations

Country	Name	City	State
Israel	Rambam healrh care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ten minutes
Primary	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	Ten minutes