Microcirculation in Perforator Flaps. Enhancing Tissue Survival

NCT ID: NCT01204554

Last Updated: 2010-09-17

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

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-12-31

Brief Summary

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The aim of the present study is to assess the microcirculatory changes in the distal part of the perforator flap using ICG fluorescence angiography.

Detailed Description

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Perforator flaps are increasingly used in reconstructive surgery both as pedicled and free flaps, mostly because of reduced donor site morbidity and superior aesthetic result. However, the there is still much to learn about the hemodynamic changes within these flaps.The aim of the present study is to assess the microcirculatory changes in the distal part of the perforator flap using ICG fluorescence angiography.

Conditions

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Reconstructive Surgery Microcirculation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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Indocyanine green (ICG)

a water-soluble dye that binds to plasma proteins and remains in the intravascular space after intravenous injection.ICG has a normal plasma half life of 3-4 min. Dosage planned is 0 .5 mg/kg dose of ICG resolved in 5 % dextrose 2 mg /ml.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients submitted to elective abdominoplasty

Exclusion Criteria

* body mass index \< 30 kg/m2
* morbidly obese
* patients with comorbidity such as diabetes
* vascular disease
* smokers
* patients \< 18 years, and patients using anti-coagulant therapy
* pregnant
* severe hepatic insufficiency were excluded and a history of allergic reactions to ICG and iodide.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, Oslo County, Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Haris Mesic, M.D

Role: CONTACT

004722118080

Facility Contacts

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Haris Mesic, M.D

Role: primary

004722118080

Other Identifiers

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08/223b.2008/3837 (REK)

Identifier Type: -

Identifier Source: org_study_id