Breast cancer, skin flap necrosis Breast cancer, skin tissue death
Conditions
Interventions
Quantified fluorescence angiography using indocyanine green.
Sponsors
Medisch Spectrum Twente (MST)
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Female patients scheduled to undergo breast-conserving surgery or mastectomy for benign or malignant breast lesions.
Exclusion criteria
Exclusion criteria: Bilateral breast malignancy.History of surgery or radiation therapy on or around the thorax.Previous surgery on the contralateral breast (with respect to the tumor). Signs of active or recent inflammation/infection of the breast skin. Pregnancy or breastfeeding.History of systemic microvascular disease (e.g. Raynaud's disease, diabetic microangiopathy).Current use of vasoconstrictive medication. Contra-indications for ICG: Known allergy or hypersensitivity for ICG or iodine. Severely impaired renal function (estimated globular filtration rate < 15).Hyperthyroidism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantified perfusion parameters of healthy breast skin measured with indocyanine green fluorescence angiography. These parameters are the time-to-peak (unit = seconds) and maximal slope (unit = arbitrary units / second), extracted from fluorescent intensity-over-time curves. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is assumed that perfusion in the breast is heterogeneous; the different quadrants and the nipple–areola complex are supplied by distinct blood vessels and perforators. Consequently, normal perfusion values can vary between regions, even in healthy (non-operated) breasts. Segmental analysis can be used to establish regional reference values, which is essential for the accurate interpretation of perfusion in clinical applications, such as predicting wound healing or necrosis after mastectomy. 1. Q-FA perfusion parameters, measured specifically in the areola. 2. Q-FA parameters, measured specifically in the 4 anatomical quadrants of the breast (i.e. upper lateral, upper medial, lower lateral and lower medial). 3. Cardiovascular risk factors: BMI, smoking history, diabetes, hypertension, hyperlipidaemia. 4.Intraoperative physiological parameters: blood pressure, ventilation parameters, patient positioning. | — |
Countries
Netherlands
Contacts
Public ContactA. Christenhusz
Medisch Spectrum Twente (MST)
Outcome results
None listed