NCT05910931 Efficacy of Angiography With Indocyanine Green in the Identification of Complications After Breast Surgery
| NCT ID | NCT05910931 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital A Coruña |
| Condition | Skin Necrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 221 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 221 participants in total. It began in 2023-06-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 of vascular suffering of the skin that sometimes cause necrosis of the same. Skin necrosis is the most important adverse event in oncoplastic and reconstructive surgery of the breast, since it causes delays in adjuvant treatments to surgery, worsening of the cosmetic result, and, on occasions, loss of the implant and reconstruction. Indocyanine color green (ICG) angiography has been proposed as a diagnostic alternative to determine the vascular perfusion of the skin envelope of the breast during surgery, which would allow the removal of tissue at risk of necrosis to avoid this complication during the postoperative period. However, the scientific literature does not currently allow an adequate assessment of this diagnostic procedure due to the absence of prospective studies that have evaluated its sensitivity, specificity, and predictive values. The objective of this prospective study is to evaluate ICG angiography of skin flaps of the breast and the surgeon's decision in women with breast cancer or at high risk for breast cancer undergoing oncoplastic surgery or mastectomy with the help of skin or skin-nipple. Based on the results of this study, the sensitivity, specificity, and predictive values of this technique for the prediction of adverse events during the postoperative period will be established.
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.
Contact & Investigator
Benigno Acea Nebril, MD PhD
PRINCIPAL INVESTIGATOR
University Hospital A Coruña
Frequently Asked Questions
Who can join the NCT05910931 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 100 Years, studying Skin Necrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05910931 currently recruiting?
Yes, NCT05910931 is actively recruiting participants. Contact the research team at benigno.acea.nebril@sergas.es for enrollment information.
Where is the NCT05910931 trial being conducted?
This trial is being conducted at A Coruña, Spain.
Who is sponsoring the NCT05910931 clinical trial?
NCT05910931 is sponsored by University Hospital A Coruña. The principal investigator is Benigno Acea Nebril, MD PhD at University Hospital A Coruña. The trial plans to enroll 221 participants.