Remote Ischemic Conditioning to Reduce Burn Wound Progression

Burns Clinical Trial

— RIC in burns  

Official title:

Remote Ischemic Conditioning to Reduce Burn Wound Progression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03027596
• Other study ID #: 639/2016
• Status: Recruiting
• Phase: N/A
• First received: January 18, 2017
• Last updated: January 19, 2017
• Start date: January 2017
• Est. completion date: July 2019

Study information

• Verified date: January 2017
• Source: BG Trauma Center Tuebingen
• Contact: Jens Rothenberger, M.D.
• Phone: +4970716063898
• Email: jens.rothenberger[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Burned skin areas, which were initially vital, can be irreversibly damaged by wound progression. The aim of the present study is to evaluate the feasibility of ischemic conditioning to reduce secondary wound progression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: July 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ability to understand the study information and the consent to sign

• Thermal injury (burn / scalding) with a clinical evaluated depth of at least 2a (superficial partial)

• At least one of the following sites must not have skin lesions

: Upper arm right and left

• hospital admission within 6 hours after trauma has taken place

Exclusion Criteria:

• Participation in another experimental study

• Pregnancy (women are subjected to a pregnancy test (urine)

• Contraindication for the use of the tourniquet, for example Lymph drainage disorders after axillary lymphadenectomy or Irradiation of the axilla

• Non-compliant patients who are, e.g. Intubated

• Pure 3rd degree burns (full thickness) or charring

• Thermal injuries older than 6 hours

Related Conditions & MeSH terms

• Burns

Intervention

Procedure:
• Remote ischemic conditioning

Locations

Country	Name	City	State
Germany	BG Trauma Center, University Tübingen, Germany	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
BG Trauma Center Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of burn depth	Clinical assessment of burn depth	day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Secondary	Change in skin's relative amount of hemoglobin	relative amount of hemoglobin (Arbitrary Units)	day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Secondary	Change in skin's blood flow	blood flow (Arbitrary Units)	day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Secondary	Change in skin's oxygen saturation	oxygen saturation (%)	day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Secondary	Change in skin elasticity	objective measurement of the skin elasticity	day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180, 360
Secondary	Differences in scare development between the study groups	Assessment with the Vancouver scare scale	day 90, 180, 360