Remote Ischemic Conditioning to Reduce Burn Wound Progression

NCT ID: NCT03027596

Last Updated: 2017-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Remote ischemic conditioning

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

Group Type EXPERIMENTAL

Remote ischemic conditioning

Intervention Type PROCEDURE

Control group

no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Remote ischemic conditioning

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BG Trauma Center Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Jens Rothenberger

Dr.med

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens Rothenberger, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hand and Plastic Surgery, BG Trauma Center Tübingen, Germany

Locations

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BG Trauma Center, University Tübingen, Germany

Tübingen, Germany, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Jens Rothenberger, M.D.

Role: CONTACT

+4970716063898

Manuel Held, M.D., Priv.-Doz.

Role: CONTACT

+4970716060

Facility Contacts

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Jens Rothenberger, M.D.

Role: primary

+4970716063898

Manuel Held, M.D., Priv.-Doz.

Role: backup

+4970716060

Other Identifiers

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639/2016

Identifier Type: -

Identifier Source: org_study_id

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