Seroma of the Mammary Gland
Launched by UNIVERSITY HOSPITAL AUGSBURG · Jun 1, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called "Seroma of the Mammary Gland," is investigating a condition known as seroma, which can occur after surgeries like mastectomy in patients with breast cancer. A seroma is a buildup of fluid in the area where tissue has been removed, and it can cause complications, especially for those who receive breast implants. The study aims to gather information about postoperative seromas to improve patient care and outcomes.
Women aged 18 and older who are undergoing surgery for breast cancer, including procedures that involve removing breast tissue and placing implants or expanders, may be eligible to participate. Participants will be asked to provide informed consent, meaning they agree to take part in the study after understanding what it involves. Throughout the trial, participants can expect to be closely monitored for any complications, including seromas, and their experiences will contribute to a larger database designed to help improve future treatments.
Gender
FEMALE
Eligibility criteria
- 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
About University Hospital Augsburg
University Hospital Augsburg is a leading academic medical center located in Augsburg, Germany, dedicated to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital integrates cutting-edge medical practices with rigorous scientific inquiry, fostering collaborations between multidisciplinary teams of researchers, clinicians, and patients. With a commitment to enhancing patient outcomes and contributing to the global medical community, University Hospital Augsburg emphasizes ethical standards, patient safety, and the development of novel therapeutic approaches in various fields of medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Augsburg, Bayern, Germany
Patients applied
Trial Officials
Thorsten Kühn, Prof.
Study Chair
Eubreast Network, Baumreute 37 D-73730 Esslingen, Germany
Nina Ditsch, Prof.
Principal Investigator
University Hospital Augsburg, Stenglinstr. 2, D-86156 Augsburg, Germany
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported