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Microcirculation in Perforator Flaps. Enhancing Tissue Survival

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Oslo University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01204554
First received: September 6, 2010
Last updated: September 16, 2010
Last verified: September 2010
History of Changes
  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)
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Microcirculation in Perforator Flaps. Enhancing Tissue Survival

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Haris Mesic, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01204554     History of Changes
Other Study ID Numbers: 08/223b.2008/3837 (REK)
Study First Received: September 6, 2010
Last Updated: September 16, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Directorate of Health

Keywords provided by Oslo University Hospital:
perforator flaps

ClinicalTrials.gov processed this record on June 18, 2013