A Study of Risk Factors for the Development of Seromas (Fluid Accumulations) Following Breast Surgery

A seroma is a collection of fluid in the tissue that often forms after breast surgery—especially after a mastectomy or procedures involving implants. Seromas are among the most common complications following such surgeries. They can cause infections, delay wound healing, and, in the worst case, lead to the loss of the implant. During surgery, tissue is cut, creating small cavities under the skin. The body reacts by producing tissue fluid—usually a mixture of lymph and blood serum. If this fluid cannot drain properly, it accumulates and forms a seroma. The exact causes have not yet been fully elucidated, but immune reactions and inflammatory processes appear to play an important role.

The goal of the SerMa study (“Seroma of the Mammary Gland”) is to investigate which biological, immunological, or technical factors contribute to seroma formation. The aim is to identify high-risk patients early and develop preventive measures. To this end, various samples (swabs, blood, seroma fluid) will be collected and examined for immune markers, bacterial colonization, and tumor-related processes. Imaging techniques such as ultrasound (sonography) will also be used to detect and measure seromas. The study is purely observational and does not interfere with treatment. Additional samples (e.g., blood or seroma fluid) are simply collected and analyzed as part of the regular course of treatment. To compare the different groups of patients, participants will be assigned to 4 different study arms based on the reason for their mastectomy. The follow-up period is six months, and the primary endpoint is the identification of patients who have an increased risk of developing a seroma.

Women aged 18 and older who are scheduled to undergo a mastectomy with or without implant-based reconstruction—for example, due to breast cancer, an increased genetic risk, or for cosmetic reasons—are eligible to participate. Excluded are, among others, patients scheduled for breast-conserving therapy, those with a known immunodeficiency, a history of breast surgery, or who are currently pregnant.