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Breast Implant LeakageNCT06257251

Silicone Particles in Breast Implant Capsules

An observational study of Breast Implant Leakage, run by Brugmann University Hospital at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Breast implantation is one of the most common surgical procedures in plastic surgery. It is used to reconstruct a breast after mastectomy following cancer or to increase breast volume for aesthetic purposes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Implant Leakage
What is being tested?
Histological slides digitization
Type of treatment
Pill or oral medicine
How many people
65 participants
Where
1 siteBelgium
Study dates
14 Nov 2023to Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients admitted and operated at CHU-Brugmann (Horta \& Brien) between January 2013 and October 2023 for surgical revision of their breast implants, requiring partial or complete sampling of the peri-prosthetic capsule.

Who may be able to join

  • 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.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Belgium1 site, 1 recruiting
  • CHU Brugmann

    Brussels, 1020

    Christophe Al Sammour, Christophe.ALSAMMOUR@chu-brugmann.be

    Recruiting

Other trials in Belgium

About this study

Official title: Silicone Particles in Breast Implant Capsules: a Retrospective Monocentric Study Evaluation of Silicone Bleeding

Breast implantation is one of the most common surgical procedures in plastic surgery. It is used to reconstruct a breast after mastectomy following cancer or to increase breast volume for aesthetic purposes. Since their introduction in the 1960s, silicone breast implants have been the subject of multiple controversies, and their safety has long been questioned. One of the initial concerns was silicone bleeding, which refers to the sweating of silicone gel through the implant's shell. Once outside the implant, silicone particles accumulate in the peri-prosthetic capsule, but they can also migrate to distant sites through the lymphatic system. These particles are not entirely biologically inert, as they initiate a foreign body inflammatory reaction characterized by the presence of macrophages and giant cells that cluster around the particles. The resulting chronic inflammation can be the source of local complications, such as granuloma formation or the onset of breast pain.

Silicone bleeding was first described in the 1970s and was particularly common with second-generation implants (1970-1982), which had thin shells and low-viscosity gel. Despite the technical improvements made to current breast implants, silicone can still be detected in the peri-prosthetic capsules of silicone breast implants. Most patients are asymptomatic, but they may occasionally experience local pain.

Read more

An increasing number of patients with breast implants are suffering for breast implant illness (BII) : a disease with nonspecific systemic signs and symptoms such as fatigue, skin rash, or headaches…etc, the precise etiology of which remains unexplained. Although the causative link has never been proven, some authors hypothesize that silicone could be responsible for these systemic complaints. While there is ongoing debate and research on the topic, some people believe that silicone bleeding from breast implants may contribute to the development of BII symptoms. However, it's important to note that the connection between silicone bleeding and BII has not been definitively proven.

It is a single center retrospective study that will include a total of 65 patients who have undergone breast implant capsulectomy. Capsulectomy is a surgical procedure involving the partial or complete removal of the peri-prosthetic capsule that forms around a breast implant. The peri-prosthetic capsule is a naturally occurring fibrous tissue that forms in response to the presence of the implant in the body. Sometimes, this capsule can become thickened, contracted, or cause complications such as capsular contracture, asymmetry, or pain. Capsulectomy can be performed as part of a surgical revision of breast implants to address these complications or for other reasons.

The main objective of this study is to quantify silicone particles in the periprosthetic capsules of breast implants using an innovative method of quantification based on histological examination of capsule specimens. The secondary objective is to compare the amount of silicone in capsules from different types of breast implants (saline or silicone) to assess whether texture, shell, silicone gel and time of implantation could influence silicone bleeding and breast implant illness.

Being tested
Histological slides digitization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Histological slides digitizationOther

    Histological slides of the capsule samples taken during surgery will be collected for analysis and digitized. Using the NDPview2 software, the investigators will manually count the silicone particles present in the peri-prosthetic capsule and measure the surface area of the capsule to estimate the silicone particle density.

Study groups in NCT06257251
Study groupRoleWhat they receive
Breast implant capsulectomyPatients admitted and operated at CHU-Brugmann hospital for surgical revision of their breast implants.
Receives: Other: Histological slides digitization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Silicone particles quantity

    Manual count of the silicone particles present in the peri-prosthetic capsule

    Measured: 1 day

  2. Peri-prosthetic capsule thickness

    Peri-prosthetic capsule thickness

    Measured: 1 day

  3. Silicone particle's' size

    Size of the silicone particles present in the peri-prosthetic capsule

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2024
  2. Study start14 Nov 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06257251
Sponsor's protocol ID
CHUB-silicone
Status last verified
Feb 2024
First submitted
5 Feb 2024
Last updated
16 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Implant Leakage, run by Brugmann University Hospital at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Christophe Al Sammour (32204773997, Christophe.ALSAMMOUR@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Silicone particles quantity (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.

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