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

January 19, 2017 updated by: Jens Rothenberger, BG Trauma Center Tuebingen
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • Recruiting
        • BG Trauma Center, University Tübingen, Germany
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
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)
day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Change in skin's oxygen saturation
Time Frame: day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
oxygen saturation (%)
day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
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
day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180, 360
Differences in scare development between the study groups
Time Frame: day 90, 180, 360
Assessment with the Vancouver scare scale
day 90, 180, 360

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BG Trauma Center Tuebingen

Investigators

  • Principal Investigator: Jens Rothenberger, M.D., Hand and Plastic Surgery, BG Trauma Center Tübingen, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

January 18, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 639/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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