An interventional study of Swap collection and Seroma punction in Seroma, Breast Cancer and Mastectomy, sponsored by University Hospital Augsburg. Recruiting at 1 site in Germany. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by University Hospital Augsburg · Not applicable, Interventional, and Prevention
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.
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.
101 studies on the registry are indexed under Seroma; 22 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 100 across 92 interventional studies indexed under Seroma.
Browse Seroma studies →University Hospital Augsburg is the lead sponsor of 25 studies on the registry; 18 are open to participants now.
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Inclusion criteria study group and control group 1:
Inclusion criteria control group 2 and 3:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women with first diagnosis of breast cancer or DCIS and planned skin-sparing mastectomy and implant placement
Procedure: Swap collection · Procedure: Seroma punction · Procedure: Blood sampling · Diagnostic Test: Sonographic correlation Seroma
Women with first diagnosis of breast cancer or DCIS and planned simple mastectomy
Procedure: Swap collection · Procedure: Seroma punction · Procedure: Blood sampling · Diagnostic Test: Sonographic correlation Seroma
healthy women with high risk for breast cancer and planned bilateral risk-reducing mastectomy and implant reconstruction
Procedure: Swap collection · Procedure: Seroma punction · Procedure: Blood sampling · Diagnostic Test: Sonographic correlation Seroma
healthy women planned for plastic breast implant surgery
Procedure: Swap collection · Procedure: Seroma punction · Procedure: Blood sampling · Diagnostic Test: Sonographic correlation Seroma
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
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.
Time frame: Follow-up for each participant: 6 month
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
Plan to share: No
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University Hospital Augsburg