Status:
RECRUITING
Efficacy of Angiography With Indocyanine Green in the Identification of Complications After Breast Surgery
Lead Sponsor:
University Hospital A Coruña
Conditions:
Skin Necrosis
Complication
Eligibility:
FEMALE
18-100 years
Brief Summary
During the performance of oncoplastic surgery and skin-sparing or skin-nipple mastectomy there is a significant loss in the perfusion of the cutaneous envelope of the breast, which can produce areas o...
Detailed Description
Currently, surgery is a decisive therapeutic element in the management of women with breast cancer and at high risk for breast/ovarian cancer. In the first scenario, oncological surgery has evolved to...
Eligibility Criteria
Inclusion Criteria:
The study population includes two type of patients:
- Women who underwent oncoplastic procedures for breast conservation. This group is made up of women with breast cancer in whom the Breast Unit tumor committee recommended a breast-conserving surgical procedure. The techniques included for this study are vertical mammoplasty, horizontal mammoplasty, and local flaps by displacement or rotation.
- Women undergoing a skin or skin/nipple-sparing mastectomy with immediate breast reconstruction. This group is made up of patients with a diagnosis of breast carcinoma, who require a mastectomy as surgical treatment, as well as those high-risk women whose mastectomy is aimed at reducing the risk of breast cancer. The surgical techniques included in this group are Carlson type 1, 2, 3 and 4 skin-sparing mastectomies and nipple and skin-sparing mastectomies using inframammary and vertical approaches. In all patients, the type of breast reconstruction will be the placement of a definitive implant in the prepectoral position.
Exclusion Criteria:
- Women with iodine allergy or thyroid disease are excluded from this study.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT05910931
Start Date
June 1 2023
End Date
July 31 2025
Last Update
July 23 2024
Active Locations (1)
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1
Hospital Abente y Lago
A Coruña, Spain, 15001