DIEP Flap Perfusion Evaluated by DIRT and ICG-FA.

University Hospital of North Norway

Status: Unknown

Conditions: Reconstructive Surgical Procedures

Treatments: Diagnostic Test: Dynamic infrared thermography (DIRT) and indocyanine green fluorescence angiography (ICG-FA)

Study type: Observational

Funder types: Other

Identifiers

NCT04115995

22017/1641

Details and patient eligibility

About

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.

Full description

Introduction:

'The primary aim of our study is to compare invasive and non-invasive techniques to select a dominant perforator when harvesting a DIEP-flap for autologous breast reconstruction.

The secondary aim is to compare Dynamic Infrared Thermography (DIRT) and Laser Fluorescence Angiography (LFA) of Indocyanine green (ICG) in order to see whether they could be useful in the early detection of insufficient perfusion following the microvascular anastomotic procedure in DIEP flaps.

Material and Method:

Patients selected for breast reconstruction with autologous tissue were examined with preoperative CTA and a handheld Doppler Ultrasound for perforator mapping. Thereafter visual images from same area was obtained with dynamic infraredeed thermography (DIRT) and Indocyanin green fluorescent angiography (ICG-FA) before and after dissection of the skin flap with preserved medial and lateral DIEP perforators. Reconstructed breasts with hemi-DIEP-flaps were intraoperatively evaluated with DIRT and LFA immediately after the completion and opening of the microvascular anastomosis.The recorded images from the different techniques were assesses in relation to clinical outcome.

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Enrollment: 30 estimated patients

Sex: Female

Ages: 25 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.