## Protocol Section
### Identification Module
**NCT ID:** NCT06414785

**Acronym:** INFLAMA

**Brief Title:** Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants

**Official Title:** INFLAMA : Histological and Molecular Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants

#### Organization Study ID Info
**ID:** 2024/870
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Besancon
### Status Module
#### Completion Date
**Date:** 2025-05-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-03

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Institut de Science des Matériaux de Mulhouse IS2M

**Class:** UNKNOWN

**Name:** NOVOTEC labs (lyon)

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Universitaire de Besancon

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

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.

### Conditions Module

**Conditions:**

- Breast Implant; Complications

- Breast Expansion Prosthesis

**Keywords:**

- type of texturing of implants

- periprosthetic capsule fragment

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** 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

**Name:** analysis of samples of periprosthetic capsules taken during breast implant change procedure

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** characteristics of inflammation according to the importance of silicone exposure

**Time Frame:** immediately after surgery

#### Secondary Outcomes

**Description:** 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.

**Measure:** characteristics of inflammation according to the type of texturing of implants

**Time Frame:** immediately after surgery

**Measure:** Characterize the inflammatory reaction within the periprosthetic capsule histologically, depending on the importance of silicone exposure.

**Time Frame:** immediately after surgery

**Measure:** Characterize the inflammatory reaction within the periprosthetic capsule histologically, according to texturation.

**Time Frame:** immediately after surgery

**Measure:** Identify a possible relationship between the characteristics of inflammation and the presence of a clinical shell.

**Time Frame:** immediately after surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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".

**Gender Based:** True

**Maximum Age:** 99 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Women Requiring a change of unilateral/bilateral breast implants or breast expansion prosthesis

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** i1pluvy@chu-besancon.fr

**Name:** Isabelle PLUVY, MD

**Phone:** +33381218988

**Role:** CONTACT

**Contact 2:**

**Email:** apozet@chu-besancon.fr

**Name:** astrid pozet

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Besançon

**Contacts:**

***Contact 1:***

- **Email:** i1pluvy@chu-besancon.fr

- **Name:** Isabelle Pluvy, MD

- **Role:** CONTACT

**Country:** France

**Facility:** CHU de Besançon

**Status:** RECRUITING

**Zip:** 25030

#### Overall Officials

**Official 1:**

**Affiliation:** CHU de Besançon

**Name:** Isabelle PLUVY

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: HIGH

- As Found: Inflammation

### Condition Browse Module - Meshes

- ID: D000007249

- Term: Inflammation

### Misc Info Module

- Version Holder: 2024-05-31
