Actively Recruiting
Molecular Mechanisms Associated With Breast Implant Complications
Led by Indiana University · Updated on 2025-04-10
1000
Participants Needed
3
Research Sites
N/A
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
Researchers are investigating the role of bacterial biofilms in complications related to breast implants, including Breast Implant Illness (BII), which is linked to symptoms similar to autoimmune and connective tissue disorders. This observational study involves three groups: women with breast implants showing BII symptoms, women with breast implants without BII symptoms, and women without breast implants who have had breast surgery. The study aims to understand how bacterial biofilms and immune responses may contribute to these complications. The research focuses on analyzing oxidized lipids called oxylipins, which form due to interactions between bacterial biofilms and the host's body. Samples collected include blood, breast tissue removed during surgery, breast implants, and surrounding capsules. Immune cells such as T cells and macrophages, along with cytokines, will also be studied to assess the immune response related to implants and biofilms. Participants will undergo breast implant removal or breast surgery as part of their medical care. Researchers will collect samples during these procedures and analyze biofilms, oxylipins, cytokines, and immune cell activity over about one year. The primary outcomes include detecting biofilms and studying immune interactions in blood and tissue. This observational study involves careful monitoring to better understand breast implant-related complications and immune effects.
CONDITIONS
Brief 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 (for breast implant subjects)
- Willing and able to comply with protocol instructions
- Undergoing breast surgery (for subjects without breast implants)
- Ability to understand study procedures and provide informed consent
You will not qualify if you...
- Unable to understand the procedures, risks, and benefits of the study
- Pregnant females
- Immunodeficiency conditions such as HIV/AIDS or SCID
- Currently taking immunosuppressive medications
- Prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus immediate recovery period
Participants undergo breast implant removal or breast surgery as part of routine healthcare. Tissue and blood samples are collected during and immediately after surgery to study biofilm presence and immune responses.
1 surgical visit (in-person)
Duration - Up to 1 year
Participants are monitored for up to one year to analyze host-biofilm interaction mediated oxylipins, cytokines, and immune cell activation in blood and breast tissue samples.
Periodic visits depending on individual follow-up schedules
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.
B
Bryce Hockman
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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