Safety and Tolerance of Local Heat Application in the Paralyzed Area of Patients With Complete Paraplegia

Not Applicable

Completed

• Conditions: Perfusion; Complications
• Interventions: Device: Hilotherm; Device: HydroSun

• 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

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-12-07
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-23
• Primary Completion: 2017-06
• Study Completion: 2017-08
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-12

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

Arm && Interventions

Group	Intervention	Description
Hilotherm	Hilotherm	application of heat (maximum of 43°C) for 30 minutes
HydroSun	HydroSun	application of ultraviolet light for 30 minutes

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