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RECRUITING
NCT05736354

Molecular Mechanisms Associated With Breast Implant Complications

Sponsor: Indiana University

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2021-01-03

Completion Date

2028-06-30

Last Updated

2025-04-10

Healthy Volunteers

No

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