Remote Ischemic Conditioning to Reduce Burn Wound Progression

Overview

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.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Prevention
  • Masking: Single (Participant)
• Study Primary Completion Date: December 2018

Interventions

• Procedure: Remote ischemic conditioning

Arms, Groups and Cohorts

• Experimental: Remote ischemic conditioning
  • Four cycles of 5 min occlusion and reperfusion in an extremity using a tourniquet.
• No Intervention: Control group
  • no intervention

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • BG Trauma Center Tuebingen
• Provider of Information About this Clinical Study
  • Principal Investigator: Jens Rothenberger, Dr.med – BG Trauma Center Tuebingen
• Overall Official(s)
  • Jens Rothenberger, M.D., Principal Investigator, Hand and Plastic Surgery, BG Trauma Center Tübingen, Germany
• Overall Contact(s)
  • Jens Rothenberger, M.D., +4970716063898, jens.rothenberger@gmail.com