BurnsRIC in burnsNCT03027596
Remote Ischemic Conditioning to Reduce Burn Wound Progression
A study testing Remote ischemic conditioning in people with Burns, run by BG Trauma Center Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2017to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
BG Trauma Center, University Tübingen, Germany
Tübingen, Germany, 72076
Jens Rothenberger, M.D., +4970716063898, jens.rothenberger@gmail.com
Manuel Held, M.D., Priv.-Doz., +4970716060, mheld@bgu-tuebingen.de
About this study
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.
- Conditions
- Burns
- Being tested
- Remote ischemic conditioning
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic conditioning | Experimental | Four cycles of 5 min occlusion and reperfusion in an extremity using a tourniquet. Receives: Procedure: Remote ischemic conditioning |
| Control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of burn depth
Clinical assessment of burn depth
Measured: day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Secondary outcomes (5)
Change in skin's relative amount of hemoglobin
relative amount of hemoglobin (Arbitrary Units)
Measured: day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Change in skin's blood flow
blood flow (Arbitrary Units)
Measured: day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Change in skin's oxygen saturation
oxygen saturation (%)
Measured: day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Change in skin elasticity
objective measurement of the skin elasticity
Measured: day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180, 360
Differences in scare development between the study groups
Assessment with the Vancouver scare scale
Measured: day 90, 180, 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2018 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BG Trauma Center Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Rothenberger, BG Trauma Center Tuebingen
- Investigators
- Jens Rothenberger, M.D., Principal investigator, Hand and Plastic Surgery, BG Trauma Center Tübingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027596
- Sponsor's protocol ID
- 639/2016
- Acronym
- RIC in burns
- Status last verified
- Jan 2017
- First submitted
- 18 Jan 2017
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning to Reduce Burn Wound Progression
- ClinicalTrials.gov ID
- NCT03027596
- Acronym / sponsor ID
- RIC in burns / 639/2016
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- BG Trauma Center TuebingenUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic conditioning | Experimental | Procedure: Remote ischemic conditioningFour cycles of 5 min occlusion and reperfusion in an extremity using a tourniquet. |
| Control group | No intervention | –no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to understand the study information and the consent to sign
- : Upper arm right and left
Key exclusion criteria (6 listed)
- Participation in another experimental study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic conditioning | Procedure or surgery | Remote ischemic conditioning |
Primary outcome
Change of burn depth
Time frame: day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Clinical assessment of burn depth
5 secondary outcomes
Change in skin's relative amount of hemoglobin
Time frame: 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
Change in skin's oxygen saturation
Time frame: 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
Differences in scare development between the study groups
Time frame: day 90, 180, 360
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Rothenberger, M.D. principal investigator
Hand and Plastic Surgery, BG Trauma Center Tübingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning in people with Burns, run by BG Trauma Center Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens Rothenberger, M.D. (+4970716063898, jens.rothenberger@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of burn depth (time frame: day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2017.