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

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ClinicalTrials.gov Identifier: NCT03027596
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):
Jens Rothenberger, 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.

Condition or disease Intervention/treatment Phase
Burns Procedure: Remote ischemic conditioning Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Remote Ischemic Conditioning to Reduce Burn Wound Progression
Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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)

  3. Change in skin's oxygen saturation [ Time Frame: day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180 ]
    oxygen saturation (%)

  4. 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

  5. Differences in scare development between the study groups [ Time Frame: day 90, 180, 360 ]
    Assessment with the Vancouver scare scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027596


Contacts
Contact: Jens Rothenberger, M.D. +4970716063898 jens.rothenberger@gmail.com
Contact: Manuel Held, M.D., Priv.-Doz. +4970716060 mheld@bgu-tuebingen.de

Locations
Germany
BG Trauma Center, University Tübingen, Germany Recruiting
Tuebingen, Germany, 72076
Contact: Jens Rothenberger, M.D.    +4970716063898    jens.rothenberger@gmail.com   
Contact: Manuel Held, M.D., Priv.-Doz.    +4970716060    mheld@bgu-tuebingen.de   
Sponsors and Collaborators
BG Trauma Center Tuebingen
Investigators
Principal Investigator: Jens Rothenberger, M.D. Hand and Plastic Surgery, BG Trauma Center Tübingen, Germany

Responsible Party: Jens Rothenberger, Dr.med, BG Trauma Center Tuebingen
ClinicalTrials.gov Identifier: NCT03027596     History of Changes
Other Study ID Numbers: 639/2016
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Burns
Wounds and Injuries