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NCT Number: NCT05899387

Seroma of the Mammary Gland

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Augsburg, Department of Gynecology and Obstetrics

Augsburg, Bavaria, 86156, Germany

Location status: Recruiting

Location contact

Melitta Köpke, Dr.

CONTACT

[email protected]

Nina Ditsch, Prof.

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Swap collection

Procedure

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 punction

Procedure

Puncturing of a seroma in case of occurence and clinical need

blood sampling

Procedure

Blood sampling at defined time points according to protocol

Sonographic correlation Seroma

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Comparison of findings in local and systemic measurements in patients with and without seroma.

    Time frame: Follow-up for each participant: 6 month

  2. Comparison of the groups with or without cancer regarding development of seroma.

    Time frame: Follow-up for each participant: 6 month

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Melitta Köpke, Dr. med.

CONTACT

[email protected]

+49 (0)821 400 165862

Nina Ditsch, Prof.

CONTACT

[email protected]

+49 (0)821 400 165809

Sponsors and collaborators

Lead sponsor

University Hospital Augsburg

Other

Registry information

Official study 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

Acronym: SerMa

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2023
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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