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Molecular Mechanisms Associated With Breast Implant Complications

Recruitingn/aAges 18 Years - anyFemaleIndiana University
NCT05736354 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Bacterial biofilms cause implant failures, chronic inflammation, and immune polarization. The study investigates the possible role of bacterial biofilm as a factor in the etiology of Breast Implant Illness. Three patient cohorts will be studied (A) Subjects with breast implant with BII manifestations (B) Subjects with breast implants without BII manifestations (C) Subjects without breast implants who underwent breast surgery procedure. Blood, surgically discarded tissue, implants, and associated capsules will be collected through this protocol.

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📋 Eligibility rules (as published)
Inclusion Criteria for breast implant subjects: * Age greater than or equal to 18 years * Undergoing removal of breast implant * Willing and able to comply with protocol instructions Inclusion Criteria for subjects undergoing breast surgeries (other than implant removal) * Age greater than or equal to 18 years * Undergoing breast surgery * Willing and able to comply with protocol instructions Exclusion Criteria: * Individuals who are deemed unable to understand the procedures, risks, and benefits of the study, (i.e., unable to provide informed consent) * Pregnant females * Immunodeficiency (HIV/AIDS, SCID) * Currently on immunosuppressive medications * Prisoners
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What it tests

  • Not listed
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Where

3 sites
IU Health North Hospital
Carmel, United States
Meridian Plastic Surgeons
Carmel, United States
IU Health Methodist Hospital
Indianapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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