Microcirculation in Perforator Flaps. Enhancing Tissue Survival

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2010

Detailed Description

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.

Interventions

  • Drug: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Mean pixel intensity using dynamic laser-induced-fluorescence-videoangiography
    • Time Frame: dec. 2008–des 2010
    • Perfusion measurements were conducted intraoperatively by assessing microcirculation using the technique of dynamic laser-induced-fluorescence-videoangiography (IC-VIEW, PULSION Medical Systems AG, Munich, Germany).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Oslo University Hospital
  • Provider of Information About this Clinical Study
    • Dr. Haris Mesic, Oslo University Hospital
  • Overall Contact(s)
    • Haris Mesic, M.D, 004722118080, Haris.Mesic@oslo-universitetssykehus.no

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