Postoperative Management with a Polyurethane Cup Containing an Oxygenated Oleic Matrix in Nipple-Sparing Mastectomy with Immediate Reconstruction: A Single-Center Retrospective Observational Study.

Background/

Objectives

Nipple-sparing mastectomy with immediate reconstruction is a preferred option for selected patients undergoing prophylactic or therapeutic mastectomy. Optimizing postoperative wound care is essential to support healing, preserve the nipple-areola complex, and prevent delays in oncologic treatments. This retrospective observational study aimed to evaluate the clinical outcomes associated with the use of the NovoX® Cup medical device in post-NSM surgical wound management, assessing clinical-surgical outcomes and quality of life (QoL).

Methods

We conducted a retrospective observational study on 54 patients who underwent NSM with immediate reconstruction at AOUI Verona between January 2025 and January 2026; Novox® Cup was applied intraoperatively and changed every 48 h according to protocol. Surgeon-reported outcomes were assessed by the skin flap viability scale and the complications by Clavien-Dindo classification. Patient-reported outcomes were assessed via the Wound-QoL17 questionnaire at 7, 30, and 90 days. Clinical outcomes were supported by photographic documentation.

Results

Mean age was 51.5 years; BMI averaged 23.9 kg/m2. Local complications occurred in 30.4% of cases (infections 12%, dehiscence 10%, seromas 4%). Mean healing time was 15 days, with 87.4% of patients having drains removed by day 14. One patient required surgical revision, and one (1.8%) experienced delayed adjuvant therapy. Wound-QoL17 responses showed minimal discomfort and high satisfaction. Clinical evaluation revealed favorable wound appearance and preserved NAC perfusion within 48 h.

Conclusions

Novox® Cup appears effective in supporting wound healing and NAC preservation after NSM, with high patient satisfaction and minimal treatment delays. Its integration into postoperative care may enhance outcomes and maintain oncologic timelines.