Seroma of the Mammary Gland

Not Applicable

Recruiting

• Conditions: Seroma; Breast Cancer; Mastectomy; Breast Implant; Complications

• Registration Number: NCT05899387
• Lead Sponsor: University Hospital Augsburg

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.

Study Timeline

• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-06-01
• Study First Posted: 2023-06-12
• Study Start: 2024-04-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Augsburg, Department of Gynecology and Obstetrics; 🇩🇪 Augsburg, Bayern, Germany