Abstract OT3-20-04: SerMa – Seroma formations of the Mammary gland in breast cancer patients after mastectomy and implant-based reconstruction (EUBREAST 5)

Abstract

Abstract Background Postoperative seroma formations are one of the most common and serious complications after implant-based breast reconstruction and can lead to implant and thus breast loss. The cause hasn`t yet been clarified. Hypothesis generating and thus as a basis for this multicenter study is the suspicion of a connection between immunological-inflammatory processes that promote the development of a seroma. First promising results of the pilot phase (SerMa pilot) have been published and gave the first impulse for this study. Trial design The SerMa (EUBREAST 5) study is a prospective, multicenter, interventional, international study including patients with primary breast cancer and a skin-/nipple-sparing mastectomy combined with an implant-based reconstruction method. Control groups were chosen to work out common group-specific differences. Intra- or directly preoperatively collected blood as well as intraoperatively collected local smear using swabs are preserved specimens. Follow-up includes visits after 2 and 6 weeks as well as after 6 months. In case of a seroma formation fluid aspirations are preserved for laboratory analyses. Eligibility criteria: The study population contains patients with primary diagnosis of breast cancer scheduled for skin-/nipple-sparing mastectomy and implant-based breast reconstruction. The three control groups are: one with simple mastectomy without breast reconstruction as well as healthy persons with implant insert but without breast cancer after bilateral risk reducing mastectomy or last in case of purely cosmetic implant placement. Specific aims: The main objective of the study is to identify a patient subgroup with an increased risk of seroma development for future precision elucidation regarding the prevention of postoperative complications such as implant and thus breast loss. FACS-/Bioplex and microbiome analyses will be applied for the detection of certain immune markers, microbiobes and microbiome diversity using preoperative blood samples, intraoperative local smear collection and in case of later seroma formations also postoperative seroma aspirations. Secondary endpoints include the comparison of these factors and elaborate differences between study and control groups. Furthermore clinico-pathological factors as well as different surgical methods are compared. Statistical methods: A statistical plan for this analysis was specifically developed (Power analyses with Wilcoxon-Mann-Whitney test) and leads to a number of 300 participants per group. Target accrual: Planned start: Q1/2023 Contact: EUBREAST e.V. Citation Format: Nina Ditsch, Nicole Pochert, Udo Jeschke, Mariella Schneider, Melitta Koepke, Maggie Banys-Paluchowski, Claudia Traidl-Hoffmann, Christian Dannecker, Thorsten Kühn. SerMa – Seroma formations of the Mammary gland in breast cancer patients after mastectomy and implant-based reconstruction (EUBREAST 5) [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr OT3-20-04.