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Seroma of the Mammary Gland

RECRUITINGN/ASponsored by University Hospital Augsburg
Actively Recruiting
PhaseN/A
SponsorUniversity Hospital Augsburg
Started2024-04-01
Est. completion2027-07-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion criteria study group and control group 1:

* Written informed consent
* Age ≥ 18 years
* all stages of DCIS or primary breast cancer (T1-T4, N0 or N+, M0) including all histopathological subtypes (ER/PR positive, ER positive/PR negative, Her-2/neu positive and triple negative)
* Surgical procedure planned including ablatio or subcutaneous mastectomy with implant or expander insertion

Inclusion criteria control group 2 and 3:

* Written informed consent
* Age ≥ 18 years
* Surgical procedure planned with implant or expander insertion with or without subcutaneous mastectomy

Exclusion criteria:

* Age \<18 years
* Male sex
* Breast cancer patients planned for breast conserving therapy
* Recurrent breast cancer disease
* History of breast surgery
* Diagnosis of LCIS only
* Pregnancy at time of diagnosis
* Patients with a known immunodeficiency

Conditions5

Breast CancerBreast Implant; ComplicationsCancerMastectomySeroma

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