Safety and Tolerance of Local Heat Application in the Par... | NCT03001531

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

NCT03001531

Sponsor

Swiss Paraplegic Research, Nottwil

Status

Completed

Last Update Posted

Nov 12, 2020Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Perfusion; Complications

Interventions

HydroSun
Hilotherm

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Jun 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Dec 7, 2016

First Submission Date that Met QC Criteria

Dec 20, 2016

First Posted Date

Dec 23, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2020

Last Update Posted Date

Nov 12, 2020Actual

Name	Class
University Hospital, Basel, Switzerland	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
HydroSun	Device	a skin area of the lower limb will be treated three times with ultraviolet light emitted by a halogen lamp	HydroSun

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Swiss Paraplegic Centre		Nottwil			Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided