Clinical Trial

NIR Device for Assessment of Skin Flap Perfusion in Breast Surgery: A Pilot Interventional Study

Study acronym: ADisIRast
Completed
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Summary
The goal of this single-center, nonrandomized, interventional non-profit pilot study is to evaluate the feasibility and clinical utility of a non-invasive near-infrared spectroscopy (NIRS) imaging device for assessing skin-flap tissue oxygen saturation in adult women undergoing mastectomy and immediate breast reconstruction after oncological surgery. The main questions it aims to answer are: * Can NIRS imaging provide reproducible measurements of tissue oxygen saturation (StO₂) in mastectomy skin flaps before surgery, during the intraoperative phase, and during postoperative follow-up? * Can spatial and temporal variations in StO₂ identify areas of potentially reduced flap perfusion or impaired tissue viability? * Can NIRS-derived oxygenation measurements support the assessment of postoperative flap healing and ischemic complications? Participants will: * undergo non-invasive NIRS imaging of the breast skin flap before surgery; * undergo one intraoperative NIRS acquisition during mastectomy and immediate breast reconstruction; * undergo repeated NIRS imaging during postoperative follow-up visits; * receive standard surgical treatment and postoperative care according to routine clinical practice. NIRS imaging is performed for study purposes and does not influence intraoperative surgical decision-making or the choice of reconstructive procedure.
Trial Details
NCT Number NCT07680296
Lead Sponsor National Research Council, Institute of Clinical Physiology, Italy
Conditions Breast Cancer, Breast Reconstruction, Mastectomy
Enrollment 20 participants
Start Date 2024-10-10
Primary Completion 2026-02-13 (estimated)
Study Completion 2026-02-13 (estimated)
Updated on ClinicalTrials.gov 2026-07-02