Actively Recruiting
Prospective Study to Evaluate Angiography With Indocyanine Green for Identifying Complications After Oncoplastic Surgery and Skin/Nipple-Sparing Mastectomy
Led by University Hospital A Coruña · Updated on 2024-07-23
221
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of indocyanine green (ICG) angiography to identify skin areas at risk of necrosis during oncoplastic surgery or skin-sparing mastectomy in women with breast cancer or at high risk for breast cancer. Skin necrosis is a serious complication that can delay further treatment, require additional surgery, and negatively impact cosmetic outcomes and quality of life. This study aims to determine the sensitivity, specificity, and predictive values of ICG angiography in predicting postoperative complications. The study involves women undergoing oncoplastic breast-conserving surgery or skin/nipple-sparing mastectomy with immediate breast reconstruction using a prepectoral implant. ICG angiography will be performed at three key surgical points: before starting the procedure to visualize vascular anatomy, after breast tissue removal to assess flap viability, and after implant placement and wound closure. The SPY System with SPY-Q software will be used to capture these images. Participants will be monitored for postoperative complications up to one month after surgery. Researchers will assess vascularity before surgery, surgical planning, and intraoperative timing. The main outcomes include the accuracy of ICG angiography during surgery and its ability to predict postoperative complications. This observational study will help establish the value of ICG angiography in surgical decision-making and improving patient outcomes.
CONDITIONS
Brief Title
Efficacy of Angiography With Indocyanine Green in the Identification of Complications After Breast Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women who underwent oncoplastic procedures for breast conservation recommended by the Breast Unit tumor committee
- Women undergoing skin or skin/nipple-sparing mastectomy with immediate breast reconstruction
- Surgical techniques include vertical mammoplasty, horizontal mammoplasty, local flaps, and Carlson type 1 to 4 skin-sparing mastectomies
- Placement of definitive implant in the prepectoral position
- Female participants aged 18 to 100 years
You will not qualify if you...
- Women with iodine allergy
- Women with thyroid disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the surgical procedure (single day)
Participants undergo breast surgery with intraoperative indocyanine green (ICG) angiography to identify areas at risk for skin necrosis and other complications. The angiography includes multiple injections during surgery to assess vascular anatomy, skin flap viability, and post-implant perfusion.
1 surgical visit (in-person)
Duration - Up to 1 month
Participants are monitored for postoperative complications including skin necrosis, infections, hematoma, and seroma up to 1 month after surgery.
Approximately 3 to 4 follow-up visits (in-person)
Trial Site Locations
Total: 1 location
1
Hospital Abente y Lago
A Coruña, Spain, 15001
Actively Recruiting
Research Team
B
Benigno Acea Nebril, MD PhD
A
Alejandra García Novoa, MD PhD
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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