Early Detection of Pressure Induced Tissue Damage by Infrared Spectroscopy (ODP) Device
Not Applicable
Completed
- Conditions
- Pressure Ulcer Not Visible
- Interventions
- Device: Infrared spectroscopy (ODP)
- Registration Number
- NCT03518190
- Lead Sponsor
- 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
- 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/
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Suspected pressure injury Infrared spectroscopy (ODP) Patients evaluated with high-risk for pressure injury
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rambam healrh care campus
🇮🇱Haifa, Israel
Rambam healrh care campus🇮🇱Haifa, Israel