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Seroma of the Mammary Gland
Sponsor: University Hospital Augsburg
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
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.
Seroma punction
Puncturing of a seroma in case of occurence and clinical need
Blood sampling
Blood sampling at defined time points according to protocol
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