Remote Ischemic Conditioning to Reduce Burn Wound Progression
RIC in burns
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 18, 2017
CompletedFirst Posted
Study publicly available on registry
January 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedJanuary 23, 2017
January 1, 2017
1.9 years
January 18, 2017
January 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change of burn depth
Clinical assessment of burn depth
day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Secondary Outcomes (5)
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's oxygen saturation
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
Differences in scare development between the study groups
day 90, 180, 360
Study Arms (2)
Remote ischemic conditioning
EXPERIMENTALFour cycles of 5 min occlusion and reperfusion in an extremity using a tourniquet.
Control group
NO INTERVENTIONno intervention
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BG Trauma Center, University Tübingen, Germany
Tübingen, Germany, 72076, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jens Rothenberger, M.D.
Hand and Plastic Surgery, BG Trauma Center Tübingen, Germany
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.med
Study Record Dates
First Submitted
January 18, 2017
First Posted
January 23, 2017
Study Start
January 1, 2017
Primary Completion
December 1, 2018
Study Completion
July 1, 2019
Last Updated
January 23, 2017
Record last verified: 2017-01