Microcirculation in Perforator Flaps. Enhancing Tissue Survival

University of Oslo (UIO)

Status and phase: Unknown; Early Phase 1

Conditions: Reconstructive Surgery; Microcirculation

Treatments: Drug: Indocyanine green (ICG)

Study type: Interventional

Funder types: Other

Identifiers

NCT01204554

08/223b.2008/3837 (REK)

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)