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Study identifier: NCT05736354 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Molecular Mechanisms Associated With Breast Implant Complications

Condition: Breast Implant; Complications · Infection or Inflammation  ·  Sponsor: Indiana University

PhaseN/A
Planned participants1000
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Mithun Sinha, PhD.  ·  3172782713  ·  mitsinha@iu.edu

Bryce Hockman  ·  3172782715  ·  bbhockma@iu.edu

Always discuss trial participation with your own doctor first.

Locations (3)

IU Health North HospitalCarmel, Indiana, United StatesRecruiting
Meridian Plastic SurgeonsCarmel, Indiana, United StatesRecruiting
IU Health Methodist HospitalIndianapolis, Indiana, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT05736354