Remote Ischemic Conditioning to Reduce Burn Wound Progres... | NCT03027596

Studies
Remote Ischemic Conditioning to Reduce Burn Wound Progression

NCT03027596

Sponsor

BG Trauma Center Tuebingen

Status

Unknown status

Last Update Posted

Jan 23, 2017Estimated

Enrollment

140Estimated

Phase

Not Applicable

Conditions

Burns

Interventions

Remote ischemic conditioning

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Dec 2018Estimated

Completion Date

Jul 2019Estimated

First Submitted Date

Jan 18, 2017

First Submission Date that Met QC Criteria

Jan 19, 2017

First Posted Date

Jan 23, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2017

Last Update Posted Date

Jan 23, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Remote ischemic conditioning	Experimental	Four cycles of 5 min occlusion and reperfusion in an extremity using a tourniquet.	Procedure: Remote ischemic conditioning
Control group	No Intervention	no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remote ischemic conditioning	Procedure		Remote ischemic conditioning

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change in skin's relative amount of hemoglobin	relative amount of hemoglobin (Arbitrary Units)	day 0, 1, 2, 3, 4,5, 7, 11,18,21, 90,180
Change in skin's blood flow	blood flow (Arbitrary Units)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jens Rothenberger, M.D.	Contact	+4970716063898		jens.rothenberger@gmail.com
Manuel Held, M.D., Priv.-Doz.	Contact	+4970716060		mheld@bgu-tuebingen.de

Overall Officials

Name	Affiliation	Role
Jens Rothenberger, M.D.	Hand and Plastic Surgery, BG Trauma Center Tübingen, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BG Trauma Center, University Tübingen, Germany	Recruiting	Tübingen	Germany	72076	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided