Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia
Not Applicable
Completed
- Conditions
- Perfusion; Complications
- Registration Number
- NCT03001531
- Lead Sponsor
- Swiss Paraplegic Research, Nottwil
- Brief Summary
Preconditioning of regional skin is known to reduce post surgery complications due to increased perfusion and better skin condition. The aim of this study is to prove that local heating through a standardized device in patients with spinal cord injury induces no burnings or other relevant side effects. The investigators expect an increased regional perfusion, temperature and redness.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- men and women
- aged from 18 to 65 years
- paraplegia Th2-Th12
- spinal cord injury had occurred >12 weeks ago
Exclusion Criteria
- infections
- fever
- diabetes
- heart failure stadium III
- renal insufficiency stadium III.
- scars, wounds or other injuries in the area of treatment
- skin type V and VI on Fitzpatrick scale
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method presence of burn injury up to 24 hours grade 1 (hyperemia, redness), grade 2 a/b (blisters) and grade 3 (necrosis)
- Secondary Outcome Measures
Name Time Method blood perfusion before and 1min after the application of light or heat perfusion (PeriFlux System 5000) in perfusion units
skin redness before and 1min after the application of light or heat visual inspection
skin surface temperature before and 1min after the application of light or heat measuring surface temperature with thermometer
Trial Locations
- Locations (1)
Swiss Paraplegic Centre
🇨🇭Nottwil, Switzerland
Swiss Paraplegic Centre🇨🇭Nottwil, Switzerland