Early detection of pressure ulcers in individuals with a complete spinal cord injury
- Conditions
- Decubituspressure soresPressure ulcers10041543
- Registration Number
- NL-OMON44664
- Lead Sponsor
- Technische Universiteit Eindhoven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
Group 1
* Adult
* Have a sensory and motor complete lesion, ASIA A between L1 and C4
* Lesion acquired less than 1 year ago
* Possible to collect a non-contaminated urine sample (e.g. naturally controlled urination, clean intermittent catheterisation, indwelling catheter with a sample port)
* Signed informed consent ;Group 2+4
* Adult
* Have a sensory and motor complete lesion, ASIA A between L1 and C4
* Lesion acquired over 1 year ago.
* Possible to collect a non-contaminated urine sample (e.g. naturally controlled urination, clean intermittent catheterisation, indwelling catheter with a sample port)
* Signed informed consent ;Group 3
* Adult
* In good health
* Signed informed consent
All groups
* Mental disability that hinders the ability to understand and comply with the informed consent
* Diagnosed skin disease
* Oncological patients
* If a subject is unable to obtain urine samples themselves and do not have assistance.
* Fever (temperature > 38*C) will lead to temporary exclusion
* Have had a pressure ulcers diagnosed in the past 6 months.;Extra exclusion criteria for group 1+2+3
* Active infections at the start of the study (determined by POCT CRP) will lead to temporary exclusion
* If a subject in the home situation does not have the ability to store samples at minus 20*C.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The concentration of several biomarkers in urine.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To determine possible causes for changes in biomarker concentration not<br /><br>associated with a PU.</p><br>