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

Swiss Paraplegic Research, Nottwil15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Perfusion; Complications

Interventions

HydroSunDEVICE

a skin area of the lower limb will be treated three times with ultraviolet light emitted by a halogen lamp

HilothermDEVICE

a skin area of the lower limb will be treated three times with heat applied by a sleeve

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Swiss Paraplegic Centre

Nottwil, Switzerland

Outcomes

Primary Outcomes

presence of burn injury

grade 1 (hyperemia, redness), grade 2 a/b (blisters) and grade 3 (necrosis)

Time frame: up to 24 hours

Secondary Outcomes

blood perfusion

perfusion (PeriFlux System 5000) in perfusion units

Time frame: before and 1min after the application of light or heat

skin surface temperature

measuring surface temperature with thermometer

Time frame: before and 1min after the application of light or heat

skin redness

visual inspection

Time frame: before and 1min after the application of light or heat

Data from ClinicalTrials.gov

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