Status:
UNKNOWN
DIEP Flap Perfusion Evaluated by DIRT and ICG-FA.
Lead Sponsor:
University Hospital of North Norway
Collaborating Sponsors:
UiT The Arctic University of Norway
Conditions:
Reconstructive Surgical Procedures
Eligibility:
FEMALE
25-70 years
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...
Detailed 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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04115995
Start Date
January 16 2019
End Date
December 31 2019
Last Update
October 4 2019
Active Locations (1)
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1
Univesity Hospital of North Norway
Tromsø, Norway, 9038