Breast Implant; ComplicationsINFLAMANCT06414785
Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants
An observational study of Breast Implant; Complications and Breast Expansion Prosthesis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The use of breast implants, both in cosmetic and restorative surgery, is common. It is a device consisting of a silicone elastomer envelope and the container of which may be silicone gel or saline. They can be texturing carriers (roughness) on the surface of their envelope. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Implant; Complications, Breast Expansion Prosthesis
- What is being tested?
- analysis of samples of periprosthetic capsules taken during breast implant change procedure
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2024to 31 May 2025
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women Requiring a change of unilateral/bilateral breast implants or breast expansion prosthesis
Who may be able to join
- Women over the age of 18 years old
- Requiring a change of unilateral/bilateral breast implants or breast expansion prosthesis for cosmetic surgery or breast reconstruction
- Subject not objecting to the use of personal data and/or biological samples
- Affiliation to or beneficiary of a French social security scheme.
Who cannot join
- Transgender men and patients
- Pregnant women, and nursing mothers
- Persons deprived of their liberty by a judicial or administrative decision;
- Persons undergoing psychiatric care under duress;
- Persons admitted to a health or social establishment for purposes other than research
- Persons of full age who are subject to a legal protection measure or who cannot express their consent
- Subject being in the period of exclusion from another study or foreseen by the "national volunteer file".
Trial locations and contacts
1 site in 1 country.
astrid pozet contact
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon, 25030
Isabelle Pluvy, MD, i1pluvy@chu-besancon.fr
About this study
Official title: INFLAMA : Histological and Molecular Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants
The use of breast implants, both in cosmetic and restorative surgery, is common. It is a device consisting of a silicone elastomer envelope and the container of which may be silicone gel or saline. They can be texturing carriers (roughness) on the surface of their envelope.
If silicone is considered inert and biocompatible, several phenomena should be noted:
Read more
- Implant placement results in the formation of a periprosthetic capsule which is the product of the inflammatory reaction and will isolate it from adjacent breast tissue
- The periprosthetic capsule and adjacent breast tissue are chronically exposed to implant silicone.
- Silicone in implants, even intact, has been shown to diffuse through the shell into the periprosthetic compartment and adjacent breast tissue
- There is a phenomenon of erosion of the surface of the implants, particularly textured, responsible for the release of silicone particles within the periprosthetic capsule
- The rupture of the prosthetic envelope is a dreaded complication, due to the alteration of the aesthetic result and the possibility of leakage of silicone gel
- Since 2016, macrotextured implants have been implicated in the occurrence of anaplastic large cell lymphoma associated with breast implants (LAC-AIM) The presence of silicone in contact with tissues seems to promote an inflammatory environment, and this phenomenon seems increased if the implant is textured.
Chronic inflammation induced by these devices can therefore have harmful consequences in the long term. INFLAMA study interested in the consequences of the presence of a silicone implant on local inflammatory phenomena within the periprosthetic capsule.
- Being tested
- analysis of samples of periprosthetic capsules taken during breast implant change procedure
- Keywords
- type of texturing of implants, periprosthetic capsule fragment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis of samples of periprosthetic capsules taken during breast implant change procedureOther
characteristics of inflammation and the importance of silicone exposure (intact implant, implant rupture in serum or silicone) at the genomic molecular level, by analyzing the level of expression of genes related to the extracellular matrix and inflammation within a periprosthetic capsule fragment
What is being measured
The primary outcome is the main question the study is designed to answer.
characteristics of inflammation according to the importance of silicone exposure
Verify the existence of a relationship between the characteristics of inflammation and the importance of silicone exposure (intact implant, implant rupture in serum or silicone) at the genomic molecular level, by analyzing the level of expression of genes related to the extracellular matrix and inflammation within a periprosthetic capsule fragment
Measured: immediately after surgery
Secondary outcomes (4)
characteristics of inflammation according to the type of texturing of implants
Check the existence of a relationship between the characteristics of inflammation and the type of texturing of implants (smooth, micro textured or macro textured), on the genomic molecular level, by analyzing the level of expression of genes related to the extracellular matrix and inflammation within a periprosthetic capsule fragment.
Measured: immediately after surgery
Characterize the inflammatory reaction within the periprosthetic capsule histologically, depending on the importance of silicone exposure.
Measured: immediately after surgery
Characterize the inflammatory reaction within the periprosthetic capsule histologically, according to texturation.
Measured: immediately after surgery
Identify a possible relationship between the characteristics of inflammation and the presence of a clinical shell.
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start3 May 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Implant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Science des Matériaux de Mulhouse IS2M, NOVOTEC labs (lyon)
- Responsible party
- Sponsor
- Investigators
- Isabelle PLUVY, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414785
- Sponsor's protocol ID
- 2024/870
- Acronym
- INFLAMA
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INFLAMA : Histological and Molecular Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants
- ClinicalTrials.gov ID
- NCT06414785
- Acronym / sponsor ID
- INFLAMA / 2024/870
- Keywords
- type of texturing of implants, periprosthetic capsule fragment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Institut de Science des Matériaux de Mulhouse IS2M, NOVOTEC labs (lyon)
- Study start
- 3 May 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of breast implants, both in cosmetic and restorative surgery, is common. It is a device consisting of a silicone elastomer envelope and the container of which may be silicone gel or saline. They can be texturing carriers (roughness) on the surface of their envelope.
If silicone is considered inert and biocompatible, several phenomena should be noted:
- Implant placement results in the formation of a periprosthetic capsule which is the product of the inflammatory reaction and will isolate it from adjacent breast tissue
- The periprosthetic capsule and adjacent breast tissue are chronically exposed to implant silicone.
- Silicone in implants, even intact, has been shown to diffuse through the shell into the periprosthetic compartment and adjacent breast tissue
- There is a phenomenon of erosion of the surface of the implants, particularly textured, responsible for the release of silicone particles within the periprosthetic capsule
- The rupture of the prosthetic envelope is a dreaded complication, due to the alteration of the aesthetic result and the possibility of leakage of silicone gel
- Since 2016, macrotextured implants have been implicated in the occurrence of anaplastic large cell lymphoma associated with breast implants (LAC-AIM) The presence of silicone in contact with tissues seems to promote an inflammatory environment, and this phenomenon seems increased if the implant is textured.
Chronic inflammation induced by these devices can therefore have harmful consequences in the long term. INFLAMA study interested in the consequences of the presence of a silicone implant on local inflammatory phenomena within the periprosthetic capsule.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women Requiring a change of unilateral/bilateral breast implants or breast expansion prosthesis
Key inclusion criteria (4 listed)
- Women over the age of 18 years old
- Requiring a change of unilateral/bilateral breast implants or breast expansion prosthesis for cosmetic surgery or breast reconstruction
- Subject not objecting to the use of personal data and/or biological samples
- Affiliation to or beneficiary of a French social security scheme.
Key exclusion criteria (7 listed)
- Transgender men and patients
- Pregnant women, and nursing mothers
- Persons deprived of their liberty by a judicial or administrative decision;
- Persons undergoing psychiatric care under duress;
- Persons admitted to a health or social establishment for purposes other than research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| analysis of samples of periprosthetic capsules taken during breast implant change procedurecharacteristics of inflammation and the importance of silicone exposure (intact implant, implant rupture in serum or silicone) at the genomic molecular level, by analyzing the level of expression of genes related to the extracellular matrix and inflammation within a periprosthetic capsule fragment | Other | – |
Primary outcome
characteristics of inflammation according to the importance of silicone exposure
Time frame: immediately after surgery
Verify the existence of a relationship between the characteristics of inflammation and the importance of silicone exposure (intact implant, implant rupture in serum or silicone) at the genomic molecular level, by analyzing the level of expression of genes related to the extracellular matrix and inflammation within a periprosthetic capsule fragment
4 secondary outcomes
characteristics of inflammation according to the type of texturing of implants
Time frame: immediately after surgery
Characterize the inflammatory reaction within the periprosthetic capsule histologically, depending on the importance of silicone exposure.
Time frame: immediately after surgery
Characterize the inflammatory reaction within the periprosthetic capsule histologically, according to texturation.
Time frame: immediately after surgery
Identify a possible relationship between the characteristics of inflammation and the presence of a clinical shell.
Time frame: immediately after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
astrid pozet contact
Isabelle PLUVY principal investigator
CHU de Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Implant; Complications and Breast Expansion Prosthesis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 4 inclusion and 7 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 May 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 France. 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 Isabelle PLUVY, MD (+33381218988, i1pluvy@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characteristics of inflammation according to the importance of silicone exposure (time frame: immediately after surgery). 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 May 2024.