Seroma of the Mammary Gland — SerMa  

Breast Cancer Clinical Trial

Official title: Prospective, International, Multicenter Non-AMG/MPG Study to Detect Possible Markers for Prediction of Seroma Development and Risk Assessment of a Breast Seroma After Skin-sparing Mastectomy and Implant Breast Reconstruction

Status Recruiting

Clinical Trial Summary

The study is designed as international, prospective, multicenter non-AMG/MPG study in cooperation with EUBREAST e.V. (European Breast Cancer Research Association of Surgical Trialists). Furthermore, it is planned to initiate a registry for postoperative breast seromas.

Clinical Trial Description

Postoperative seroma formations are one of the most common and serious complications after breast surgery, above all after mastectomy. Especially in patients who have opted for breast reconstruction using implants, seromas lead to infections and wound dehiscence which can result in implant and finally breast loss. To date, the cause of seroma development has not yet been clarified. First data of a pilot study of our research group identified an association with immunological-inflammatory processes as a possible cause for seroma development (Seroma after Simple Mastectomy in Breast Cancer-The Role of CD4+ T Helper Cells and the Evidence as a Possible Specific Immune Process; Pochert et al. 2022).

The main objective of the SerMa (Seroma of the Mammary gland) study presented here is to identify patient groups who have an increased risk of developing seromas based on immunological/inflammatory processes. Based on the findings clinical consequences should be developed in the future, such as more precise risk-adapted patient education and individualized advising regarding the selection of the reconstruction procedure, with the goal of minimizing complication rates. In addition, analyses of the tumor and the microenvironment will be performed to differentiate possible carcinoma-specific immunological processes. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Implant; Complications
• Mastectomy
• Seroma

• NCT number: NCT05899387
• Study type: Observational
• Source: University Hospital Augsburg
• Contact: Nina Ditsch, Prof.
• Phone: +49 (0)821 400 165809
• Email: nina.ditsch@uk-augsburg.de
• Status: Recruiting
• Start date: April 1, 2024
• Completion date: July 1, 2027