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RECRUITING
NCT05899387
NA

Seroma of the Mammary Gland

Sponsor: University Hospital Augsburg

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2024-04-01

Completion Date

2027-07-01

Last Updated

2025-02-28

Healthy Volunteers

Yes

Interventions

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

Locations (1)

University Hospital Augsburg, Department of Gynecology and Obstetrics

Augsburg, Bavaria, Germany