blood flow of skin flaps flap perfusion
Conditions
Interventions
For each patient, fluorescence imaging with ICG is performed. However, only in the intervention group is it permitted to actually view the images in real time and make adjustments based on the imaging
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Female patients 18 years of age and older 2. Who underwent a mastectomy for breast cancer or prophylactic due to genetic predisposition 3. Patients scheduled for elective surgery for autologous breast reconstruction, uni- or bilateral, using DIEP or msTRAM flaps 4. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Allergy to ICG, iodine or shellfish 2. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient 3. Impaired renal function defined as eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage clinically relevant fat necrosis, defined as a palpable mass, either painful or not, and with or without aesthetic complaints, and developed within three months after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Registration of re-interventions necessary to treat fat necrosis, in numbers and percentages • Registration of postoperative complications, in numbers and percentages • Duration of surgery in minutes • Percentage extra resected tissue of initial flap in grams based on perfusion assessment • Personal experience/opinion of surgeon performing surgery with fluorescent imaging using ICG. This is graded using the NASA TASK questionnaire. • Patient satisfaction using BREAST-Q questionnaire | — |
Countries
Netherlands
Contacts
Public ContactL.E. Aa
Leids Universitair Medisch Centrum
Outcome results
None listed