Using Indocyanine Green Angiography to Identify Complications After Breast Surgery
Prospective Study for the Evaluation of the Efficacy and Concordance of Angiography With Indocyanine Green in the Identification of Complications After Oncoplastic Surgery and Skin and Nipple-skin Sparing Mastectomy
This study is testing if a special imaging technique can help doctors spot areas at risk of skin problems after breast surgery to improve healing and cosmetic results for women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 221 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | University Hospital A Coruña Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (A Coruña) |
| Trial ID | NCT05910931 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of Indocyanine Green (ICG) angiography in assessing skin perfusion during oncoplastic and skin-sparing breast surgeries. The aim is to identify areas at risk of necrosis, which is a significant complication that can delay further treatments and affect cosmetic outcomes. By monitoring vascular perfusion, surgeons can make informed decisions to minimize the risk of skin necrosis postoperatively. The study includes women undergoing various breast conservation and mastectomy procedures.
Who should consider this trial
Good fit: Ideal candidates include women undergoing oncoplastic procedures or skin/nipple-sparing mastectomies for breast cancer treatment or risk reduction.
Not a fit: Patients who are not undergoing breast surgery or those with contraindications to ICG angiography may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of skin necrosis and improve postoperative outcomes for breast cancer patients.
How similar studies have performed: While the use of ICG angiography is gaining traction, this specific application in breast surgery is relatively novel and lacks extensive prior prospective studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
A Coruña
- Hospital Abente y Lago — A Coruña, Spain (Recruiting)
Study contacts
- Principal investigator: Benigno Acea Nebril, MD PhD — University Hospital A Coruña
- Study coordinator: Benigno Acea Nebril, MD PhD
- Email: benigno.acea.nebril@sergas.es
- Phone: 0034 981178000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.