Seroma of the Mammary Gland (SerMa)

Prospective, International, Multicenter Non-AMG/MPG Study to Detect Possible Markers for Prediction of Seroma Development and Risk Assessment of a Breast Seroma After Skin-sparing Mastectomy and Implant Breast Reconstruction

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Seroma; Mastectomy; Breast Implant; Complications
• Intervention / Treatment: Procedure: Swap collection; Procedure: Seroma punction; Procedure: Blood sampling

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Nina Ditsch, Prof.; Phone Number: +49 (0)821 400 165809; Email: nina.ditsch@uk-augsburg.de
• Study Contact Backup: Name: Melitta Köpke, Dr. med.; Phone Number: +49 (0)821 400 165862; Email: melitta.koepke@uk-augsburg.de

Study Locations

• Germany
  • Bayern
    • Augsburg, Bayern, Germany, 86156
      • Recruiting
      • University Hospital Augsburg, Department of Gynecology and Obstetrics
      • Contact: Nina Ditsch, Prof.; Email: nina.ditsch@uk-agsburg.de
      • Contact: Melitta Köpke, Dr.; Email: melitta.koepke@uk-augsburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study is divided into four groups, of which the first is the study group and the other three are the control groups. Recruitment is planned prospectively in participating study sites. All patients planned for the procedures in accordance to the protocol should be informed about the possibility to participate in the SerMa study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Follow-up for each participant: 6 month

Secondary Outcome Measures

Outcome Measure	Time 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 groups	Follow-up for each participant: 6 month

Collaborators and Investigators

• Sponsor: University Hospital Augsburg
• Investigators: Study Chair: Thorsten Kühn, Prof., Eubreast Network, Baumreute 37 D-73730 Esslingen, Germany; Principal Investigator: Nina Ditsch, Prof., University Hospital Augsburg, Stenglinstr. 2, D-86156 Augsburg, Germany

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Seroma
• Other Study ID Numbers: 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No