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NCT05736354
Molecular Mechanisms Associated With Breast Implant Complications
Conditions: Breast Implant; Complications, Infection or Inflammation
Sex: Female
Ages: 18 Years – N/A
Enrollment: 1000
Sponsor: Indiana University
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria for breast implant subjects:Age greater than or equal to 18 yearsUndergoing removal of breast implantWilling and able to comply with protocol instructionsInclusion Criteria for subjects undergoing breast surgeries (other than implant removal)Age greater than or equal to 18 yearsUndergoing breast surgeryWilling and able to comply with protocol instructionsExclusion Criteria:Individuals who are deemed unable to understand the procedures, risks, and benefits of the study, (i.e., unable to provide informed consent)Pregnant femalesImmunodeficiency (HIV/AIDS, SCID)Currently on immunosuppressive medicationsPrisoners
Source: ClinicalTrials.gov (NCT05736354). StuddyBuddy aggregates publicly available trial information.