Microcirculation in Perforator Flaps. Enhancing Tissue Survival

Early Phase 1

• Conditions: Reconstructive Surgery; Microcirculation

• Registration Number: NCT01204554
• Lead Sponsor: Oslo University Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2008-09
• Status Verified: 2010-09
• Study First Submitted: 2010-09-06
• Study First Submitted QC: 2010-09-16
• Last Update Submitted: 2010-09-16
• Study First Posted: 2010-09-17
• Last Update Posted: 2010-09-17
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mean pixel intensity using dynamic laser-induced-fluorescence-videoangiography	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).

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway