Remote Ischemic Conditioning to Reduce Burn Wound Progression

Not Applicable

• Conditions: Burns
• Interventions: Procedure: Remote ischemic conditioning

• Registration Number: NCT03027596
• Lead Sponsor: BG Trauma Center Tuebingen

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-18
• Study First Submitted QC: 2017-01-19
• Last Update Submitted: 2017-01-19
• Study First Posted: 2017-01-23
• Last Update Posted: 2017-01-23
• Primary Completion: 2018-12
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote ischemic conditioning	Remote ischemic conditioning	Four cycles of 5 min occlusion and reperfusion in an extremity using a tourniquet.

Primary Outcome Measures

Name	Time	Method
Change of burn depth	day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180	Clinical assessment of burn depth

Secondary Outcome Measures

Name	Time	Method
Change in skin's relative amount of hemoglobin	day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180	relative amount of hemoglobin (Arbitrary Units)
Change in skin's blood flow	day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180	blood flow (Arbitrary Units)
Change in skin elasticity	day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180, 360	objective measurement of the skin elasticity
Change in skin's oxygen saturation	day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180	oxygen saturation (%)
Differences in scare development between the study groups	day 90, 180, 360	Assessment with the Vancouver scare scale

Trial Locations

Locations (1)

BG Trauma Center, University Tübingen, Germany; 🇩🇪 Tuebingen, Germany