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Molecular Mechanisms Associated With Breast Implant Complications

NCT05736354 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2025-04-10

No results posted yet for this study

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.

Conditions

  • Breast Implant; Complications
  • Infection or Inflammation

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Indiana University

    lead OTHER

Principal Investigators

  • Mithun Sinha, PhD. · Indiana University School of Medicine

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-03
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05736354 on ClinicalTrials.gov