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Brief Title: Seroma of the Mammary Gland
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
Study ID: NCT05899387
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
University Hospital Augsburg, Department of Gynecology and Obstetrics, Augsburg, Bayern, Germany
Name: Thorsten Kühn, Prof.
Affiliation: Eubreast Network, Baumreute 37 D-73730 Esslingen, Germany
Role: STUDY_CHAIR
Name: Nina Ditsch, Prof.
Affiliation: University Hospital Augsburg, Stenglinstr. 2, D-86156 Augsburg, Germany
Role: PRINCIPAL_INVESTIGATOR