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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Page 1 of 1 (1 locations)

1

Hospital Abente y Lago

A Coruña, Spain, 15001