SerMa: Seroma of the Mammary Gland
Study Details
Study Description
Brief Summary
The study is designed as international, prospective, multicenter non-AMG/MPG 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| BC, mastectomy and implant Women with first diagnosis of breast cancer or DCIS and planned skin-sparing mastectomy and implant placement |
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
|
| BC and mastectomy Women with first diagnosis of breast cancer or DCIS and planned simple mastectomy |
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
|
| High risk for BC healthy women with high risk for breast cancer and planned bilateral risk-reducing mastectomy and implant reconstruction |
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
|
| Cosmetic breast surgery healthy women planned for plastic breast implant surgery |
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
|
Outcome Measures
Primary Outcome Measures
- Identification of a patient population at increased risk for developing seroma. [Follow-up for each participant: 6 month]
Examination of seroma fluid and blood samples to identify immunological markers. Local microbiome analyses to investigate a possible bacterial colonization. Tissue analyses to determine possible carcinoma-specific immunologic processes.
Secondary Outcome Measures
- Comparison of findings in local and systemic measurements in patients with and without seroma. [Follow-up for each participant: 6 month]
- Comparison of the groups with or without cancer regarding development of seroma. [Follow-up for each participant: 6 month]
- Comparison of the clinicopathologic differences between the implant and simple mastectomy group within both cancer groups [Follow-up for each participant: 6 month]
Eligibility Criteria
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:
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Age <18 years
-
Male sex
-
Breast cancer patients planned for breast conserving therapy
-
Recurrent breast cancer disease
-
History of breast surgery
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Diagnosis of LCIS only
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Pregnancy at time of diagnosis
-
Patients with a known immunodeficiency
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital Augsburg
Investigators
- Study Chair: Thorsten Kühn, Prof., Eubreast Network, Baumreute 37 D-73730 Esslingen, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1.0