Reconstructive Surgical Procedures Clinical Trial
Official title:
Perforator Mapping and Anastomosis Patency Evaluated by Dynamic Fluorescence Video Angiography of Indocyanine Green and Infrared Thermography.
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 24, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Norway | Univesity Hospital of North Norway | Tromsø |
Lead Sponsor | Collaborator |
---|---|
University Hospital of North Norway | UiT The Arctic University of Norway |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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