Seroma of the Mammary Gland
Prospective, International, Multicenter Minimal Interventional Study to Detect Possible Markers for Prediction of Seroma Development and Risk Assessment of a Breast Seroma After Mastectomy with or Without Implant-based Breast Reconstruction
University Hospital Augsburg
2,000 participants
Apr 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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
- Written informed consent
- Age ≥ 18 years
- Surgical procedure planned with implant or expander insertion with or without subcutaneous mastectomy
Exclusion Criteria8
- 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
Interventions
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.
Puncturing of a seroma in case of occurence and clinical need
Blood sampling at defined time points according to protocol
If a seroma occurs, a sonographic correlation is performed to determine the exact size of the seroma
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05899387