SeromaSerMaNCT05899387
Seroma of the Mammary Gland
A study testing Swap collection, Seroma punction and Blood sampling in people with Seroma and Breast Cancer, run by University Hospital Augsburg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Seroma, Breast Cancer, Mastectomy
- What is being tested?
- Swap collection, Seroma punction and Blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2024to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Augsburg, Department of Gynecology and Obstetrics
Augsburg, Bavaria, 86156
Nina Ditsch, Prof., nina.ditsch@uk-agsburg.de
Melitta Köpke, Dr., melitta.koepke@uk-augsburg.de
About this study
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
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.
Read the 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.
- Conditions
- Seroma, Breast Cancer, Mastectomy, Breast Implant; Complications
- Being tested
- Swap collection, Seroma punction, Blood sampling, Sonographic correlation Seroma
- Medical subject headings
- Seroma, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swap collectionProcedure or surgery
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.
Seroma punctionProcedure or surgery
Puncturing of a seroma in case of occurence and clinical need
Blood samplingProcedure or surgery
Blood sampling at defined time points according to protocol
Sonographic correlation SeromaDiagnostic test
If a seroma occurs, a sonographic correlation is performed to determine the exact size of the seroma
| Study group | Role | What they receive |
|---|---|---|
| BC, mastectomy and implant | Experimental | Women with first diagnosis of breast cancer or DCIS and planned skin-sparing mastectomy and implant placement Receives: Procedure: Swap collection; Procedure: Seroma punction; Procedure: Blood sampling; Diagnostic Test: Sonographic correlation Seroma |
| BC and mastectomy | Active comparator | Women with first diagnosis of breast cancer or DCIS and planned simple mastectomy Receives: Procedure: Swap collection; Procedure: Seroma punction; Procedure: Blood sampling; Diagnostic Test: Sonographic correlation Seroma |
| High risk for BC | Active comparator | healthy women with high risk for breast cancer and planned bilateral risk-reducing mastectomy and implant reconstruction Receives: Procedure: Swap collection; Procedure: Seroma punction; Procedure: Blood sampling; Diagnostic Test: Sonographic correlation Seroma |
| Cosmetic breast surgery | Active comparator | healthy women planned for plastic breast implant surgery Receives: Procedure: Swap collection; Procedure: Seroma punction; Procedure: Blood sampling; Diagnostic Test: Sonographic correlation Seroma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of a patient population at increased risk for developing seroma.
- 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.
Measured: Follow-up for each participant: 6 month
Secondary outcomes (3)
Comparison of findings in local and systemic measurements in patients with and without seroma.
Measured: Follow-up for each participant: 6 month
Comparison of the groups with or without cancer regarding development of seroma.
Measured: Follow-up for each participant: 6 month
Comparison of the clinicopathologic differences between the implant and simple mastectomy group within both cancer groups
Measured: Follow-up for each participant: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Apr 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeromaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Augsburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Ditsch, University Hospital Augsburg
- Investigators
- Thorsten Kühn, Prof., Study chair, Eubreast Network, Baumreute 37 D-73730 Esslingen, GermanyNina Ditsch, Prof., Principal investigator, University Hospital Augsburg, Stenglinstr. 2, D-86156 Augsburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899387
- Sponsor's protocol ID
- 1.0
- Acronym
- SerMa
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2023
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05899387
- Acronym / sponsor ID
- SerMa / 1.0
- Conditions
- Seroma, Breast Cancer, Mastectomy, Breast Implant; Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital AugsburgUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BC, mastectomy and implant | Experimental | Procedure: Swap collection, Procedure: Seroma punction, Procedure: Blood sampling, Diagnostic Test: Sonographic correlation SeromaWomen with first diagnosis of breast cancer or DCIS and planned skin-sparing mastectomy and implant placement |
| BC and mastectomy | Active comparator | Procedure: Swap collection, Procedure: Seroma punction, Procedure: Blood sampling, Diagnostic Test: Sonographic correlation SeromaWomen with first diagnosis of breast cancer or DCIS and planned simple mastectomy |
| High risk for BC | Active comparator | Procedure: Swap collection, Procedure: Seroma punction, Procedure: Blood sampling, Diagnostic Test: Sonographic correlation Seromahealthy women with high risk for breast cancer and planned bilateral risk-reducing mastectomy and implant reconstruction |
| Cosmetic breast surgery | Active comparator | Procedure: Swap collection, Procedure: Seroma punction, Procedure: Blood sampling, Diagnostic Test: Sonographic correlation Seromahealthy women planned for plastic breast implant surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Age <18 years
- Male sex
- Breast cancer patients planned for breast conserving therapy
- Recurrent breast cancer disease
- History of breast surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swap collectionPerforming 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 or surgery | BC and mastectomy, BC, mastectomy and implant, Cosmetic breast surgery, High risk for BC |
| Seroma punctionPuncturing of a seroma in case of occurence and clinical need | Procedure or surgery | BC and mastectomy, BC, mastectomy and implant, Cosmetic breast surgery, High risk for BC |
| Blood samplingBlood sampling at defined time points according to protocol | Procedure or surgery | BC and mastectomy, BC, mastectomy and implant, Cosmetic breast surgery, High risk for BC |
| Sonographic correlation SeromaIf a seroma occurs, a sonographic correlation is performed to determine the exact size of the seroma | Diagnostic test | BC and mastectomy, BC, mastectomy and implant, Cosmetic breast surgery, High risk for BC |
Primary outcome
Identification of a patient population at increased risk for developing seroma.
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swap collection, Seroma punction and Blood sampling in people with Seroma and Breast Cancer, run by University Hospital Augsburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina Ditsch, Prof. (+49 (0)821 400 165809, nina.ditsch@uk-augsburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of a patient population at increased risk for developing seroma. (time frame: Follow-up for each participant: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.