An observational study in Breast Implant; Complications and Breast Expansion Prosthesis, sponsored by Centre Hospitalier Universitaire de Besancon. Recruiting at 1 site in France. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Centre Hospitalier Universitaire de Besancon · Observational
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's planned enrollment of 100 is close to the median of 95 across 895 observational studies indexed under Inflammation.
Browse Inflammation studies →Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women Requiring a change of unilateral/bilateral breast implants or breast expansion prosthesis
Exclusion Criteria:
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
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
Time frame: immediately after surgery
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.
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
Plan to share: No
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Centre Hospitalier Universitaire de Besancon