Remote Ischemic Conditioning to Reduce Burn Wound Progression

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03027596

Acronym

RIC in burns

Enrollment

140

Registered

2017-01-23

Start date

2017-01-31

Completion date

2019-07-31

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

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.

Interventions

PROCEDURERemote ischemic conditioning

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Change in skin's relative amount of hemoglobin	day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180	relative amount of hemoglobin (Arbitrary Units)
Change in skin's blood flow	day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180	blood flow (Arbitrary Units)
Change in skin's oxygen saturation	day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180	oxygen saturation (%)
Change in skin elasticity	day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180, 360	objective measurement of the skin elasticity
Differences in scare development between the study groups	day 90, 180, 360	Assessment with the Vancouver scare scale

Countries

Germany

Contacts

Primary ContactJens Rothenberger, M.D.

jens.rothenberger@gmail.com+4970716063898

Backup ContactManuel Held, M.D., Priv.-Doz.

mheld@bgu-tuebingen.de+4970716060

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026