RecruitingNCT05736354

Molecular Mechanisms Associated With Breast Implant Complications


Sponsor

Indiana University

Enrollment

1,000 participants

Start Date

Jan 3, 2021

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • Age greater than or equal to 18 years
  • Undergoing removal of breast implant
  • Willing and able to comply with protocol instructions
  • Age greater than or equal to 18 years
  • Undergoing breast surgery
  • Willing and able to comply with protocol instructions

Exclusion Criteria5

  • 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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Locations(3)

IU Health North Hospital

Carmel, Indiana, United States

Meridian Plastic Surgeons

Carmel, Indiana, United States

IU Health Methodist Hospital

Indianapolis, Indiana, United States

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NCT05736354


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