Seroma of the Mammary Gland

Condition(s) studied

Investigational drug(s) / intervention(s)

Swap collection: Performing the surgery (Mastectomy with or without implant reconstruction; Insertion of Breast implants for control group 3) according to valid standards. In addition, taking swabs intraoperatively according to protocol from skin and surgical site.

Seroma punction: Puncturing of a seroma in case of occurence and clinical need

Blood sampling: Blood sampling at defined time points according to protocol

Sonographic correlation Seroma: If a seroma occurs, a sonographic correlation is performed to determine the exact size of the seroma

Study summary

The study is designed as international, prospective, minimal interventional 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.

Eligibility

Primary outcome measure(s)

• Identification of a patient population at increased risk for developing seroma. — Follow-up for each participant: 6 month
  * Examination of seroma fluid and blood samples to identify immunological markers. * Local microbiome analyses to investigate a possible bacterial colonization. * Tissue analyses to determine possible carcinoma-specific immunologic processes.

Trial sites (1)

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