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Cutaneous Remote Ischemic Preconditioning in Plastic Surgery (RIPC)

Primary Purpose

Ischemic Preconditioning

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
remote ischemic preconditioning
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ischemic Preconditioning focused on measuring remote ischemic preconditioning, free flap, microcirculation

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy male and female subjects aged 18 to 35 years

Exclusion Criteria:

  • soft tissue inflammation or osteomyelitis, peripheral arterial occlusive disease, vasculitis, chronic kidney or liver disease, cardiac dysfunction, arterial hypotension and any type of vasoactive medication, i.e. ß-blockers, calcium channel blockers, nitroglycerin

Sites / Locations

  • Medical School Hannover

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

remote ischemic preconditioning

Arm Description

Outcomes

Primary Outcome Measures

Change in microcirculation
capillary blood flow [arbitrary units AU] capillary blood velocity [AU] tissue oxygen saturation [%] relative postcapillary venous filling pressure [AU]

Secondary Outcome Measures

Full Information

First Posted
November 4, 2010
Last Updated
November 4, 2010
Sponsor
Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT01235286
Brief Title
Cutaneous Remote Ischemic Preconditioning in Plastic Surgery
Acronym
RIPC
Official Title
Effects of Remote Ischemic Preconditioning in Cutaneous Microcirculation of Anterolateral Thigh Flaps
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hannover Medical School

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: In plastic and reconstructive surgery, free flaps are routinely used for treatment of soft tissue defects. Treatment strategies aim at reducing or preventing flap necrosis by conditioning tissue tolerance against ischemia. Although previous studies indicate that remote ischemic preconditioning (RIPC) is a systemic phenomenon, only a few studies have focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of remote ischemic preconditioning on a potential free flap location in a human in-vivo setting for the first time. Conclusion: Remote ischemic preconditioning improves cutaneous tissue oxygen saturation, arterial capillary blood flow and postcapillary venous flow in a remote free flap donor location. To what extent remote preconditioning might ameliorate the reperfusion injury of free flap transplantation, further clinical trials have to evaluate both in the means of microcirculatory assessment and partial or total flap loss as end points of these studies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Preconditioning
Keywords
remote ischemic preconditioning, free flap, microcirculation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
remote ischemic preconditioning
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
remote ischemic preconditioning
Intervention Description
A standardized location for microcirculatory assessment was determined on the left leg of each participant between the proximal and distal third of a drawn line between the anterior superior iliac spine and the lateral aspect of the Patella. The healthy subjects had to rest before starting data assessment in a horizontal position for 15 minutes. The probe was taped on the left upper leg in a standardized manner after localizing the measuring point. A blood pressure cuff was applied on the contralateral upper arm. Baseline data was assessed over 5 minutes before starting remote ischemia. Three circles of a five minute ischemia were applied at the contralateral right upper arm at suprasystolic levels. Parameters of microcirculation were assessed continuously over time. Microcirculation during the reperfusion phase was ascertained over 10 minutes after first and second remote ischemia and 15 minutes after the third remote ischemia.
Primary Outcome Measure Information:
Title
Change in microcirculation
Description
capillary blood flow [arbitrary units AU] capillary blood velocity [AU] tissue oxygen saturation [%] relative postcapillary venous filling pressure [AU]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy male and female subjects aged 18 to 35 years Exclusion Criteria: soft tissue inflammation or osteomyelitis, peripheral arterial occlusive disease, vasculitis, chronic kidney or liver disease, cardiac dysfunction, arterial hypotension and any type of vasoactive medication, i.e. ß-blockers, calcium channel blockers, nitroglycerin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Kraemer, MD
Organizational Affiliation
Medical School Hannover, Plastic, Hand and Reconstructive Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical School Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22111972
Citation
Kraemer R, Lorenzen J, Kabbani M, Herold C, Busche M, Vogt PM, Knobloch K. Acute effects of remote ischemic preconditioning on cutaneous microcirculation--a controlled prospective cohort study. BMC Surg. 2011 Nov 23;11:32. doi: 10.1186/1471-2482-11-32.
Results Reference
derived

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Cutaneous Remote Ischemic Preconditioning in Plastic Surgery

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