Cutaneous Remote Ischemic Preconditioning in Plastic Surgery

NCT ID: NCT01235286

Last Updated: 2010-11-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Preconditioning

Keywords

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remote ischemic preconditioning, free flap, microcirculation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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remote ischemic preconditioning

Group Type EXPERIMENTAL

remote ischemic preconditioning

Intervention Type PROCEDURE

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.

Interventions

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remote ischemic preconditioning

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Hannover Medical School, Plastic, Hand and Reconstructive Surgery

Principal Investigators

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Robert Kraemer, MD

Role: PRINCIPAL_INVESTIGATOR

Medical School Hannover, Plastic, Hand and Reconstructive Surgery

Locations

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Medical School Hannover

Hanover, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 22111972 (View on PubMed)

Other Identifiers

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Kraemer001

Identifier Type: -

Identifier Source: org_study_id