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Completed

NCT Number: NCT03001531

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

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.

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Key information

Conditions

Perfusion; Complications

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swiss Paraplegic Centre

Nottwil, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HydroSun

Device

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

Hilotherm

Device

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

Primary outcomes

  1. presence of burn injury

    Time frame: up to 24 hours

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

Secondary outcomes

  1. blood perfusion

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

    perfusion (PeriFlux System 5000) in perfusion units

  2. skin surface temperature

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

    measuring surface temperature with thermometer

  3. skin redness

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

    visual inspection

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Collaborators

  • University Hospital, Basel, Switzerland

Registry information

Acronym: DecuHeat

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 23, 2016
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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