NCT03001531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 23, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

December 7, 2016

Last Update Submit

November 10, 2020

Conditions

Perfusion; Complications

Keywords

Complete paraplegia

Outcome Measures

Primary Outcomes (1)

  • presence of burn injury

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

    up to 24 hours

Secondary Outcomes (3)

  • blood perfusion

    before and 1min after the application of light or heat

  • skin surface temperature

    before and 1min after the application of light or heat

  • skin redness

    before and 1min after the application of light or heat

Study Arms (2)

HydroSun

ACTIVE COMPARATOR

application of ultraviolet light for 30 minutes

Device: HydroSun

Hilotherm

ACTIVE COMPARATOR

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

Device: Hilotherm

Interventions

HydroSunDEVICE

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

HydroSun
HilothermDEVICE

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

Hilotherm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women
  • aged from 18 to 65 years
  • paraplegia Th2-Th12
  • spinal cord injury had occurred \>12 weeks ago

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Switzerland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 23, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

November 12, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)