Clinical Research Directory

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

Sponsor: National Research Council, Institute of Clinical Physiology, Italy

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.

Official title: ADisIRast: Applicazione Del Dispositivo NIR Nella Breast Unit. Studio Pilota Monocentrico, Non Randomizzato, Interventistico Con Dispositivo Medico, Premarket, Non Profit, Per la Valutazione Della Perfusione Del Lembo Cutaneo Pre e Post Operatoria

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