Remote Ischemic Conditioning to Reduce Burn Wound Progression (RIC in burns)

BG Trauma Center Tuebingen

Status: Unknown

Conditions: Burns

Treatments: Procedure: Remote ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03027596

639/2016

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Remote ischemic conditioning

Experimental group

Description:

Four cycles of 5 min occlusion and reperfusion in an extremity using a tourniquet.

Treatment:

Procedure: Remote ischemic conditioning

Control group

No Intervention group

Description:

no intervention