Actively Recruiting

Age: 18Years - 100Years
FEMALE
NCT05910931

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

Led by University Hospital A Coruña · Updated on 2024-07-23

221

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 100Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women undergoing oncoplastic breast-conserving surgery recommended by a tumor committee, including vertical or horizontal mammoplasty and local flap techniques
  • Women undergoing skin or skin/nipple-sparing mastectomy with immediate breast reconstruction using prepectoral implant placement
  • Women diagnosed with breast cancer or at high risk for breast cancer who require mastectomy or risk reduction surgery
Not Eligible

You will not qualify if you...

  • Women with allergy to iodine
  • Women with thyroid disease

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Abente y Lago

A Coruña, Spain, 15001

Actively Recruiting

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Research Team

B

Benigno Acea Nebril, MD PhD

CONTACT

A

Alejandra García Novoa, MD PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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