NCT05899387

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: University Hospital Augsburg · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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
DIAGNOSTIC_TEST	Sonographic correlation Seroma	If a seroma occurs, a sonographic correlation is performed to determine the exact size of the seroma

Timeline

• Start date: 2024-04-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2023-06-12
• Last updated: 2025-02-28

Locations

1 site across 1 country: Germany