Identifying risk factors for seroma formation after breast surgery
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
Run by University Hospital Augsburg · NCT05899387 · Data updated 2026-11-12
This study is trying to find out which patients are more likely to develop fluid buildup after breast surgery so that doctors can give better advice and care to prevent it.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 2000 (estimated) |
| Sponsor | University Hospital Augsburg Academic / other |
| Locations | 1 site (Augsburg, Bavaria) |
| Status | Recruiting |
| Started | April 1, 2024 |
| Main results expected | July 1, 2027 |
| Study ends | July 1, 2027 |
| Registry record updated | February 28, 2025 |
| Trial ID | NCT05899387 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult women aged 18 and older who are scheduled for mastectomy or implant insertion due to breast cancer.
✕Probably not a fit
Patients who may not benefit include those under 18, males, or individuals with a history of breast surgery or those diagnosed with lobular carcinoma in situ (LCIS) only.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This international, prospective study aims to investigate the development of postoperative seromas in patients undergoing breast surgery, particularly mastectomy with reconstruction. The research will focus on identifying patient groups at increased risk for seroma formation based on immunological and inflammatory processes. By analyzing tumor characteristics and the surrounding microenvironment, the study seeks to develop tailored patient education and individualized surgical recommendations to reduce complication rates. Additionally, a registry for postoperative breast seromas will be initiated to enhance data collection and analysis.
Why it matters
Potential benefit: If successful, this study could lead to improved patient outcomes by minimizing the risk of seroma formation and associated complications after breast surgery.
How similar studies have gone: While this study builds on preliminary findings regarding immunological factors in seroma development, it represents a novel approach in this specific context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University Hospital Augsburg, Department of Gynecology and Obstetrics
Augsburg, Bavaria, Germany Recruiting
Study contacts
- Principal investigator: Nina Ditsch, Prof. — University Hospital Augsburg, Stenglinstr. 2, D-86156 Augsburg, Germany
- Study coordinator: Nina Ditsch, Prof.
- Email: nina.ditsch@uk-augsburg.de
- Phone: +49 (0)821 400 165809
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.