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

Swiss Paraplegic Research, Nottwil

Status: Completed

Conditions: Perfusion; Complications

Treatments: Device: Hilotherm; Device: HydroSun

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT03001531

2014-05

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

HydroSun

Active Comparator group

Description:

application of ultraviolet light for 30 minutes

Treatment:

Device: HydroSun

Hilotherm

Active Comparator group

Description:

application of heat (maximum of 43°C) for 30 minutes

Treatment:

Device: Hilotherm