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

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Completed
CT.gov ID
NCT03518190
Collaborator
(none)
31
Enrollment
1
Location
1
Arm
33.4
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: Infrared spectroscopy (ODP)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
N/A
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 :
Jul 30, 2018
Actual Primary Completion Date :
May 12, 2021
Actual Study Completion Date :
May 12, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Early detection of pressure induced tissue damage [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 [Ten minutes]

    Infrared spectroscopy will calculate using accepted statistical tools the probability of the subject getting a pressure injury within the next few days

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rambam healrh care campus Haifa Israel

Sponsors and Collaborators

  • Rambam Health Care Campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yehuda Ullmann MD, Head of Plastic Surgery Department, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT03518190
Other Study ID Numbers:
  • 0039-18-RMB
First Posted:
May 8, 2018
Last Update Posted:
Apr 28, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
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

Study Results

No Results Posted as of Apr 28, 2022