The protocol for BROWSE-P (breast reconstruction outcomes with Strattice™ or Artia™ – pre-pectoral): a cohort study to assess long-term outcomes of immediate pre-pectoral implant based breast reconstruction with Strattice™ or Artia™

Introduction: Techniques in implant-based breast reconstruction (IBBR) have evolved over the last 15 years due to the introduction of mesh or acellular dermal matrices (ADMs). Traditionally, total submuscular coverage progressed to upper pole muscle cover with lower pole ADM and now total or anterior ADM cover in the pre-pectoral plane. Data is scarce to support the pre-pectoral technique but, it is suggested to result in less postoperative pain, more natural cosmesis and avoidance of animation deformity. The BROWSE study concluded that subpectoral with Strattice™ IBBR resulted in better cosmesis and lower rates of capsular contracture when compared to the total submuscular technique. The BROWSE-P study aims to assess the safety profile of Artia™ a porcine derived ADM and review the long-term outcomes of pre-pectoral IBBR with Strattice™ and Artia™. Methods and analysis: BROWSE-P is a single center cohort study. Consecutive patients who have undergone immediate pre-pectoral IBBR with Strattice™ or Artia™ from January 2017 to December 2022 will be included. Demographic, operative, oncology, complication, and further surgery data with be collected to assess the rate of revision surgery and safety profile of Artia™. Those who have their implant reconstruction in situ will be invited for clinical assessment to assess for capsular contracture. Participants will also be asked to complete a BREAST-Q post-reconstruction module, to assess patient satisfaction and quality of life, and have medical photographs taken for an assessment of aesthetic outcome by a blinded panel using the 10-point Visser scale. We aim to collect data on 500 reconstructions and complete clinical assessment, patient reported outcomes and aesthetic assessment for 250 patients.