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Clinical Trials/NCT03027596
NCT03027596UnknownNot Applicable

Remote Ischemic Conditioning to Reduce Burn Wound Progression

BG Trauma Center Tuebingen2 sites in 1 country140 target enrollmentStarted: January 1, 2017Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
140
Locations
2
Primary Endpoint
Change of burn depth
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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 Outcomes

  • Change in skin's relative amount of hemoglobin(day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180)
  • Change in skin's blood flow(day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180)
  • Change in skin elasticity(day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180, 360)
  • Change in skin's oxygen saturation(day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180)
  • Differences in scare development between the study groups(day 90, 180, 360)

Investigators

Sponsor
BG Trauma Center Tuebingen
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jens Rothenberger

Dr.med

BG Trauma Center Tuebingen

Study Sites (2)

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Remote Ischemic Conditioning to Reduce... | Clinical Trial