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Search / Trial NCT05910931

Efficacy of Angiography With Indocyanine Green in the Identification of Complications After Breast Surgery

Launched by UNIVERSITY HOSPITAL A CORUÑA · Jun 17, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Breast Cancer Oncoplastic Surgery Breast Reconstruction Skin Sparing Mastectomy Nipple Skin Sparing Mastectomy Indocyanine Color Green

ClinConnect Summary

This clinical trial is studying a technique called Indocyanine Green (ICG) angiography, which helps doctors see how well blood is flowing to the skin of the breast during surgery. This is important because during certain breast surgeries, the skin can suffer and even die, leading to complications that may delay treatment and affect the appearance of the breast. The goal of the study is to determine how effective ICG angiography is in predicting these skin complications, which could help surgeons make better decisions during operations and improve patient outcomes.

To participate in this trial, women aged 18 to 85, who are undergoing either oncoplastic surgery (a type of surgery that aims to remove cancer while preserving breast appearance) or skin/nipple-sparing mastectomy (removing breast tissue while preserving the skin and nipple) may be eligible. However, women with allergies to iodine or thyroid problems cannot participate. Participants can expect to have their blood flow to the breast skin monitored during surgery, and the findings will help improve future surgical practices for breast cancer treatment. Additionally, the trial is currently recruiting participants, so there is an opportunity to contribute to important research that could benefit others in the future.

Gender

FEMALE

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.

About University Hospital A Coruña

University Hospital A Coruña is a leading healthcare institution in Spain, dedicated to advancing medical research and improving patient care through innovative clinical trials. Affiliated with the University of A Coruña, the hospital combines cutting-edge medical technology with a multidisciplinary approach to clinical research, focusing on a wide range of therapeutic areas. With a commitment to ethical standards and patient safety, the hospital actively collaborates with academic and industry partners to facilitate the development of new treatments and enhance health outcomes. Through its robust research infrastructure and experienced clinical team, University Hospital A Coruña plays a pivotal role in the evolution of modern medicine.

Locations

A Coruña, , Spain

Patients applied

0 patients applied

Trial Officials

Benigno Acea Nebril, MD PhD

Principal Investigator

University Hospital A Coruña

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported