Recruiting

Seroma of the Mammary Gland

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.

ClinicalTrials.gov IDNCT05899387

PhaseNA

Enrollment2000

SponsorUniversity Hospital Augsburg

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Seroma, Breast Cancer, Mastectomy, Breast Implant; Complications

About this study

Interventions

Procedure: 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.
Procedure: Seroma punction — Puncturing of a seroma in case of occurence and clinical need
Procedure: Blood sampling — Blood sampling at defined time points according to protocol
Diagnostic Test: Sonographic correlation Seroma — If a seroma occurs, a sonographic correlation is performed to determine the exact size of the seroma

Primary outcomes

Identification of a patient population at increased risk for developing seroma. (Follow-up for each participant: 6 month)

Eligibility information

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

Study locations

University Hospital Augsburg, Department of Gynecology and Obstetrics, Augsburg, Bavaria 86156 Germany

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.