Microcirculation in Perforator Flaps. Enhancing Tissue Survival

Microcirculation Clinical Trial

Official title:

Microcirculation in Perforator Flaps. Enhancing Tissue Survival

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01204554
• Other study ID #: 08/223b.2008/3837 (REK)
• Status: Recruiting
• Phase: Phase 0
• First received: September 6, 2010
• Last updated: September 16, 2010
• Start date: September 2008
• Est. completion date: December 2010

Study information

• Verified date: September 2010
• Source: Oslo University Hospital
• Contact: Haris Mesic, M.D
• Phone: 004722118080
• Email: Haris.Mesic[@]oslo-universitetssykehus.no
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Directorate of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Microcirculation
• Reconstructive Surgery

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean pixel intensity using dynamic laser-induced-fluorescence-videoangiography	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).	dec. 2008--des 2010	No