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Microcirculation in Perforator Flaps. Enhancing Tissue Survival

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Oslo University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01204554
First Posted: September 17, 2010
Last Update Posted: September 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oslo University Hospital
  Purpose
The aim of the present study is to assess the microcirculatory changes in the distal part of the perforator flap using ICG fluorescence angiography.

Condition Intervention Phase
Reconstructive Surgery Microcirculation Drug: Indocyanine green (ICG) Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Microcirculation in Perforator Flaps. Enhancing Tissue Survival

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome 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).


Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204554


Contacts
Contact: Haris Mesic, M.D 004722118080 Haris.Mesic@oslo-universitetssykehus.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0304
Contact: Haris Mesic, M.D    004722118080    haris.mesic@oslo-universitetssykehus.no   
Principal Investigator: Haris Mesic, M.D         
Sub-Investigator: Ravi Bains, MD. PhD         
Sponsors and Collaborators
Oslo University Hospital
  More Information

Responsible Party: Dr. Haris Mesic, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01204554     History of Changes
Other Study ID Numbers: 08/223b.2008/3837 (REK)
First Submitted: September 6, 2010
First Posted: September 17, 2010
Last Update Posted: September 17, 2010
Last Verified: September 2010

Keywords provided by Oslo University Hospital:
perforator flaps