INFLAMA : Histological and Molecular Characterization of Capsule Inflammation in Patients Exposed to Silicone Breast Implants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- characteristics of inflammation according to the importance of silicone exposure
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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".
结局指标
主要结局
characteristics of inflammation according to the importance of silicone exposure
时间窗: 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
次要结局
- 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)
- characteristics of inflammation according to the type of texturing of implants(immediately after surgery)
- Characterize the inflammatory reaction within the periprosthetic capsule histologically, depending on the importance of silicone exposure.(immediately after surgery)