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| Name | Class |
|---|---|
| Institut de Science des Matériaux de Mulhouse IS2M | UNKNOWN |
| NOVOTEC labs (lyon) | UNKNOWN |
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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| analysis of samples of periprosthetic capsules taken during breast implant change procedure | Other | 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 | Description | Time Frame |
|---|---|---|
| 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 | immediately after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Women Requiring a change of unilateral/bilateral breast implants or breast expansion prosthesis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle PLUVY, MD | Contact | +33381218988 | i1pluvy@chu-besancon.fr | |
| astrid pozet | Contact | apozet@chu-besancon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Isabelle PLUVY | CHU de Besançon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Recruiting | Besançon | 25030 | France |
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| immediately after surgery |
| Characterize the inflammatory reaction within the periprosthetic capsule histologically, depending on the importance of silicone exposure. | immediately after surgery |
| Characterize the inflammatory reaction within the periprosthetic capsule histologically, according to texturation. | immediately after surgery |
| Identify a possible relationship between the characteristics of inflammation and the presence of a clinical shell. | immediately after surgery |