Identifying risk factors for seroma formation after breast surgery
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital Augsburg Academic / other |
| Locations | 1 site (Augsburg, Bavaria) |
| Trial ID | NCT05899387 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adult women aged 18 and older who are scheduled for mastectomy or implant insertion due to breast cancer.
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.
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 performed: While this study builds on preliminary findings regarding immunological factors in seroma development, it represents a novel approach in this specific context.
Eligibility criteria
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 this trial is running
Augsburg, Bavaria
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.