Intraoperative Indocyanine Green Laser Angiography; Postoperative Outcomes for Autologous Tissue Flaps

Breast Cancer Clinical Trial

Official title:

Intraoperative Indocyanine Green Laser (ICG) Angiography; Evaluation of Postoperative Outcomes for Breast Reconstruction With Autologous Tissue Flaps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03069261
• Other study ID #: ICG-angiography
• Status: Completed
• Phase: N/A
• First received: February 27, 2017
• Last updated: October 25, 2017
• Start date: August 1, 2016
• Est. completion date: September 30, 2017

Study information

• Verified date: February 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to identify and compare complication rates between autologous breast reconstruction techniques with and without the inclusion on intraoperative indocyanine green (ICG) angiography.

Description:

ICG-angiography is a real-time visualization of tissue perfusion using intravenous fluorescence. It allows the surgeon a tool for intraoperatively assessment of tissue perfusion of the autologous flap, providing a basis for trimming of hypo perfused areas. The study evaluates the effect of inclusion of this technique by examine postoperative outcomes retrospectively. This is done by differentiation between major and minor complications to evaluate the greatest gains of the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: September 30, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eligible patients over the age of 18 years

• Deemed suitable for breast reconstruction with the latissimus dorsi (LD) myocutaneous flap, muscle sparring LD flap or transverse rectus abdominal muscle (TRAM) flap

Exclusion Criteria:

• Patients with recurrence of breast cancer

• Smoking 4 weeks prior of operation

• Not able to read and understand Danish

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Indocyanine green angiography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major complications	Major complications included necrosis of most of the flap (2/3), total flap loss and surgical evacuated hematoma.	Measured at 6 months followup.
Secondary	Minor complications	A minor complication included clinical sign of infection, prolonged wound healing (defined as prolonged healing time requiring dressing changes assisted by health personnel), fat necrosis and skin necrosis.	Measured from day 0 with 6 months followup
Secondary	Timing of reconstruction	Comparison of the timing of the reconstruction with the complication rate, comparing immediate reconstructions with delayed reconstructions.	Measured from day 0 with 6 months followup