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

NCT05910931 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 221

Last updated 2024-07-23

No results posted yet for this study

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.

Conditions

  • Skin Necrosis
  • Complication

Interventions

DRUG

ICG angiography

* A first injection with the patient asleep before starting the intervention to visualize the vascular anatomy of each patient and assess the pedicles and incisions. * A second bolus after breast resection to assess the viability of skin flaps and glandular pedicles. * A third injection to obtain an angiography after implant placement and wound closure. For angiography, the SPY System with the SPY-Q software will be used.

Sponsors & Collaborators

  • University Hospital A Coruña

    lead OTHER

Principal Investigators

  • Benigno Acea Nebril, MD PhD · University Hospital A Coruña

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-06-30
Completion
2025-07-31
FDA Drug
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05910931 on ClinicalTrials.gov