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

Primary Purpose

Burns

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sponsored by
BG Trauma Center Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Burns

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • BG Trauma Center, University Tübingen, GermanyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Remote ischemic conditioning

Control group

Arm Description

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

no intervention

Outcomes

Primary Outcome Measures

Change of burn depth
Clinical assessment of burn depth

Secondary Outcome Measures

Change in skin's relative amount of hemoglobin
relative amount of hemoglobin (Arbitrary Units)
Change in skin's blood flow
blood flow (Arbitrary Units)
Change in skin's oxygen saturation
oxygen saturation (%)
Change in skin elasticity
objective measurement of the skin elasticity
Differences in scare development between the study groups
Assessment with the Vancouver scare scale

Full Information

First Posted
January 18, 2017
Last Updated
January 19, 2017
Sponsor
BG Trauma Center Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT03027596
Brief Title
Remote Ischemic Conditioning to Reduce Burn Wound Progression
Acronym
RIC in burns
Official Title
Remote Ischemic Conditioning to Reduce Burn Wound Progression
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
BG Trauma Center Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remote ischemic conditioning
Arm Type
Experimental
Arm Description
Four cycles of 5 min occlusion and reperfusion in an extremity using a tourniquet.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic conditioning
Primary Outcome Measure Information:
Title
Change of burn depth
Description
Clinical assessment of burn depth
Time Frame
day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Secondary Outcome Measure Information:
Title
Change in skin's relative amount of hemoglobin
Description
relative amount of hemoglobin (Arbitrary Units)
Time Frame
day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Title
Change in skin's blood flow
Description
blood flow (Arbitrary Units)
Time Frame
day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Title
Change in skin's oxygen saturation
Description
oxygen saturation (%)
Time Frame
day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Title
Change in skin elasticity
Description
objective measurement of the skin elasticity
Time Frame
day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180, 360
Title
Differences in scare development between the study groups
Description
Assessment with the Vancouver scare scale
Time Frame
day 90, 180, 360

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Rothenberger, M.D.
Phone
+4970716063898
Email
jens.rothenberger@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Held, M.D., Priv.-Doz.
Phone
+4970716060
Email
mheld@bgu-tuebingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Rothenberger, M.D.
Organizational Affiliation
Hand and Plastic Surgery, BG Trauma Center Tübingen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
BG Trauma Center, University Tübingen, Germany
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Rothenberger, M.D.
Phone
+4970716063898
Email
jens.rothenberger@gmail.com
First Name & Middle Initial & Last Name & Degree
Manuel Held, M.D., Priv.-Doz.
Phone
+4970716060
Email
mheld@bgu-tuebingen.de

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Remote Ischemic Conditioning to Reduce Burn Wound Progression

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