Examining silicone particles in breast implant capsules
Silicone Particles in Breast Implant Capsules: a Retrospective Monocentric Study Evaluation of Silicone Bleeding
This study looks at whether tiny silicone particles in the capsules around breast implants cause inflammation and complications like pain and lumps in patients who had their implants revised.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 65 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brugmann University Hospital Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT06257251 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the presence of silicone particles in the capsules surrounding breast implants, which can occur due to silicone leakage. It aims to understand the inflammatory response triggered by these particles, which may lead to complications such as granuloma formation and breast pain. The study involves digitizing histological slides from patients who underwent surgical revision of their breast implants at CHU-Brugmann Hospital between January 2013 and October 2023. By analyzing these samples, researchers hope to gain insights into the biological effects of silicone particles on surrounding tissues.
Who should consider this trial
Good fit: Ideal candidates include patients who have undergone surgical revision of breast implants at CHU-Brugmann Hospital within the specified timeframe.
Not a fit: Patients who have not had breast implants or those who have not undergone surgical revision at the specified hospital will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of complications related to breast implants and improve patient management strategies.
How similar studies have performed: While there have been studies on silicone implants, this specific focus on silicone particles and their inflammatory effects is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients admitted and operated at CHU-Brugmann Hospital (Horta \& Brien) * Surgery between January 2013 and October 2023 * Type of surgery: surgical revision of their breast implants requiring partial or complete sampling of the peri-prosthetic capsule. Exclusion Criteria: - None
Where this trial is running
Brussels
- CHU Brugmann — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Socorro Ortiz, MD — CHU Brugmann
- Study coordinator: Christophe Al Sammour
- Email: Christophe.ALSAMMOUR@chu-brugmann.be
- Phone: 32204773997
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.