NCT01204554

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Sep 2008

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 17, 2010

Status Verified

September 1, 2010

Enrollment Period

2.2 years

First QC Date

September 6, 2010

Last Update Submit

September 16, 2010

Conditions

Reconstructive SurgeryMicrocirculation

Keywords

perforator flaps

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Indocyanine green (ICG)DRUG

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients submitted to elective abdominoplasty

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0304, Norway

RECRUITING

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Haris Mesic, M.D

CONTACT

004722118080Haris.Mesic@oslo-universitetssykehus.no

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2010

First Posted

September 17, 2010

Study Start

September 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 17, 2010

Record last verified: 2010-09

Locations

NO(1)