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

Perfusion; Complications Clinical Trial

— DecuHeat  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03001531
• Other study ID #: 2014-05
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: August 2017

Study information

• Verified date: November 2020
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Paraplegia
• Perfusion; Complications

Intervention

Device:
• HydroSun
a skin area of the lower limb will be treated three times with ultraviolet light emitted by a halogen lamp
• Hilotherm
a skin area of the lower limb will be treated three times with heat applied by a sleeve

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil	University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of burn injury	grade 1 (hyperemia, redness), grade 2 a/b (blisters) and grade 3 (necrosis)	up to 24 hours
Secondary	blood perfusion	perfusion (PeriFlux System 5000) in perfusion units	before and 1min after the application of light or heat
Secondary	skin surface temperature	measuring surface temperature with thermometer	before and 1min after the application of light or heat
Secondary	skin redness	visual inspection	before and 1min after the application of light or heat