Actively Recruiting
Molecular Mechanisms Associated With Breast Implant Complications
Led by Indiana University · Updated on 2025-04-10
1000
Participants Needed
3
Research Sites
390 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Molecular Mechanisms Associated With Breast Implant Complications
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 (other than implant removal)
- Willing and able to comply with protocol instructions
You will not qualify if you...
- Unable to understand the procedures, risks, and benefits of the study or unable to provide informed consent
- Pregnant females
- Immunodeficiency conditions such as HIV/AIDS or SCID
- Currently taking immunosuppressive medications
- Prisoners
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
IU Health North Hospital
Carmel, Indiana, United States, 46032
Actively Recruiting
2
Meridian Plastic Surgeons
Carmel, Indiana, United States, 46290
Actively Recruiting
3
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
M
Mithun Sinha, PhD.
CONTACT
B
Bryce Hockman
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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