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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05899387
Acronym
SerMa
Enrollment
2000
Registered
2023-06-12
Start date
2024-04-01
Completion date
2027-07-01
Last updated
2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Breast Implant; Complications, Mastectomy, Seroma

Brief 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.

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

PROCEDURESwap 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.

PROCEDURESeroma punction

Puncturing of a seroma in case of occurence and clinical need

PROCEDUREBlood sampling

Blood sampling at defined time points according to protocol

DIAGNOSTIC_TESTSonographic correlation Seroma

If a seroma occurs, a sonographic correlation is performed to determine the exact size of the seroma

Sponsors

University Hospital Augsburg
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frame
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 groupsFollow-up for each participant: 6 month

Countries

Germany

Contacts

Primary ContactNina Ditsch, Prof.
nina.ditsch@uk-augsburg.de+49 (0)821 400 165809
Backup ContactMelitta Köpke, Dr. med.
melitta.koepke@uk-augsburg.de+49 (0)821 400 165862

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026