Prospective, International Study to Identify Markers Predicting Seroma Development After Mastectomy With or Without Implant Reconstruction

What this Trial Is About

This research aims to identify markers that predict the risk of developing seromas, a common and serious complication after breast surgery, especially mastectomy. The study focuses on women with breast cancer or those at high risk undergoing mastectomy with or without implant reconstruction. Researchers are investigating the role of immune and inflammatory processes in seroma formation and analyzing tumor and surrounding tissue to understand possible specific immune responses related to cancer. Participants receive standard surgical treatments, including mastectomy and implant placement according to their clinical situation. During surgery, swabs are collected from the skin and surgical site. If seromas occur, further procedures like seroma puncture and ultrasound are performed to assess size and manage the condition. Blood samples are taken at scheduled times to study systemic immune responses. The study is international and includes multiple groups, such as breast cancer patients with different surgical plans and healthy women undergoing cosmetic or risk-reducing breast surgery. Participants are followed for six months, during which researchers collect clinical data, imaging, and laboratory samples to compare findings between those who develop seromas and those who do not. The main outcome is to identify patient groups at increased seroma risk. Secondary outcomes include comparing local and systemic immune responses and examining differences between cancer and non-cancer groups. This follow-up period allows detailed monitoring of seroma development and related immune processes to guide future personalized care strategies.

Seroma of the Mammary Gland