Microcirculation in Perforator Flaps. Enhancing Tissue Survival

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01204554

Enrollment

Registered

2010-09-17

Start date

2008-09-30

Completion date

2010-12-31

Last updated

2010-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microcirculation, Reconstructive Surgery

Keywords

perforator flaps

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.

Interventions

DRUGIndocyanine 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Norway

Contacts

Primary ContactHaris Mesic, M.D

Haris.Mesic@oslo-universitetssykehus.no004722118080

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026