DIEP Flap Perfusion Evaluated by DIRT and ICG-FA.

NCT04115995 | Unknown DMC

• 1 other identifier: 22017/1641
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Patients selected for DIEP breast reconstruction were examined with preoperative CTA, Doppler Ultrasound, dynamic infrared thermography (DIRT) and Indocyanin green fluorescent angiography (ICG-FA) for perforator mapping. DIRT and ICG-FA were used to evaluate perfusion of selected perforators. Following anastomoses for the DIEP flap to internal mammary vessels , patency of the anastomosis was evaluated with DIRT and ICG-FA. Recorded images from all the modules were compared.

Conditions

Reconstructive Surgical Procedures

Keywords

Breast reconstruction; Perforator flaps; Computer Tomography; Indocyanine green; Fluorescence angiography; Infrared thermography; Dynamic infrared thermography; Doppler ultrasound; Angiosome; Perforasome; Flap perfusion

Outcome Measures

Primary Outcomes (2)

• Assessment of quality and location of perforating blood vessels with dynamic infrared thermography and indocyanine green angiography in autologous breast reconstruction: A comparative imaging study.

  Pre-and intraoperative use of two different imaging technologies to assess quality and location of perforating blood vessels in autologous breast reconstruction. In this study we will compare images obtained using a non-invasive imaging technique, dynamic infrared thermography and an invasive imaging technique, laser fluorescence angiography of indocyanine green.

  2 year

• Quality of microvascular anastomosis by measuring perfusion through the anastomosis using dynamic infrared thermography and laser fluorescence angiography of indocyanine green.

  The microvascular anastomosis provides blood supply to tissue used in breast reconstruction. The blood flow through the microvascular anastomosis can be monitored by use of different imaging techniques. In this study, perfusion images obtained by non-invasive dynamic infrared thermography and invasive fluorescence angiography of indocyanine green will be compared.

  2 years

Interventions

Dynamic infrared thermography (DIRT) and indocyanine green fluorescence angiography (ICG-FA) DIAGNOSTIC_TEST

DIRT and ICG FA are used intraoperatively to evaluate perfusion of the perforators and the anastomosis. Both technique are compared in their ability to visualize perfusion.

Eligibility Criteria

• Age: 25 Years - 70 Years
• Gender Eligibility Details: Only female patients are included for breast reconstruction after treatment for breast cancer.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients selected for autologous breast reconstruction with a DIEP flap.

You may qualify if:

• Post mastectomy.
• Previously breast cancer patent treated with radiation therapy.
• Breast implant reconstruction is not possible or undesired.
• Healthy patient with moderate amounts of abdominal skin laxity.
• Patient who requires a minimal to moderate volume breast reconstruction.
• The patient willing to undergo the long, complex procedure and prolonged postoperative recovery.
• The patient willing to accept an abdominal scar and a potential for donor site morbidities.
• Patients operated with prophylactic salpingo-oophorectomy due to BRCA gene mutation.

You may not qualify if:

• Pregnancy and lactation.
• Patents below the age of 18 year.
• Renal failure or hepatic failure.
• Previous allergic reactions to ICG and iodide.
• Abdominal donor site that cannot be closed primarily.
• Previous TRAM flap or abdominoplasty.
• Significant medical comorbidities that make the patient a poor surgical candidate.
• Sigarette smoking or snuff.
• Obesity / BMI \> 30.
• Previous abdominal suction-assisted lipectomy.

Sponsors & Collaborators

• University Hospital of North Norway: lead
• UiT The Arctic University of Norway: collaborator

Study Sites (1)

Univesity Hospital of North Norway

Tromsø, 9038, Norway

RECRUITING

Central Study Contacts

Louis de Weerd, MD, PhD,

CONTACT

004777669793; louis.de.weerd@unn.no

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: October 4, 2019
• Study Start: January 16, 2019
• Primary Completion: December 24, 2019
• Study Completion: December 31, 2019
• Last Updated: October 4, 2019

Record last verified: 2018-12

Locations

NO (1)