Seroma of the Mammary Gland
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Swap collection, Seroma punction, Blood sampling, Sonographic correlation Seroma.
- Who it may be relevant to
- Registry conditions: Seroma, Breast Cancer, Mastectomy, Breast Implant; Complications. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
Postoperative seroma formations are one of the most common and serious complications after breast surgery, above all after mastectomy. Especially in patients who have opted for breast reconstruction using implants, seromas lead to infections and wound dehiscence which can result in implant and finally breast loss. To date, the cause of seroma development has not yet been clarified. First data of a pilot study of our research group identified an association with immunological-inflammatory processes as a possible cause for seroma development (Seroma after Simple Mastectomy in Breast Cancer-The Role of CD4+ T Helper Cells and the Evidence as a Possible Specific Immune Process; Pochert et al. 2022).
The main objective of the SerMa (Seroma of the Mammary gland) study presented here is to identify patient groups who have an increased risk of developing seromas based on immunological/inflammatory processes. Based on the findings clinical consequences should be developed in the future, such as more precise risk-adapted patient education and individualized advising regarding the selection of the reconstruction procedure, with the goal of minimizing complication rates. In addition, analyses of the tumor and the microenvironment will be performed to differentiate possible carcinoma-specific immunological processes.
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 outcome measures
- Identification of a patient population at increased risk for developing seroma. [Time frame: Follow-up for each participant: 6 month]
Secondary outcome measures (3)
- Comparison of findings in local and systemic measurements in patients with and without seroma. [Time frame: Follow-up for each participant: 6 month]
- Comparison of the groups with or without cancer regarding development of seroma. [Time frame: Follow-up for each participant: 6 month]
- Comparison of the clinicopathologic differences between the implant and simple mastectomy group within both cancer groups [Time frame: Follow-up for each participant: 6 month]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Germany · 1 center
- University Hospital Augsburg, Department of Gynecology and Obstetrics — Augsburg
Identifiers
NCT: NCT05899387 · 1.0