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

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 Overview

• Status: Completed
• Conditions: Perfusion; Complications
• Intervention / Treatment: Device: HydroSun; Device: Hilotherm

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Nottwil, Switzerland
    • Swiss Paraplegic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: HydroSun; application of ultraviolet light for 30 minutes	Device: HydroSun; a skin area of the lower limb will be treated three times with ultraviolet light emitted by a halogen lamp
ACTIVE_COMPARATOR: Hilotherm; application of heat (maximum of 43°C) for 30 minutes	Device: Hilotherm; a skin area of the lower limb will be treated three times with heat applied by a sleeve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
presence of burn injury	grade 1 (hyperemia, redness), grade 2 a/b (blisters) and grade 3 (necrosis)	up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood perfusion	perfusion (PeriFlux System 5000) in perfusion units	before and 1min after the application of light or heat
skin surface temperature	measuring surface temperature with thermometer	before and 1min after the application of light or heat
skin redness	visual inspection	before and 1min after the application of light or heat

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Centre Nottwil
• Collaborators: University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): August 1, 2017

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (ESTIMATE): December 23, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Complete paraplegia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Paraplegia
• Other Study ID Numbers: 2014-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO