Investigating bacterial biofilms in breast implant complications
Official title: Molecular Mechanisms Associated With Breast Implant Complications
Run by Indiana University · NCT05736354 · Data updated 2026-11-12
This study is trying to see if bacteria that form biofilms are linked to problems some people have with breast implants, especially those experiencing Breast Implant Illness.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 1000 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 3 sites (Carmel, Indiana and 2 other locations) |
| Status | Recruiting |
| Started | January 3, 2021 |
| Main results expected | June 30, 2028 |
| Study ends | June 30, 2028 |
| Registry record updated | June 11, 2026 |
| Trial ID | NCT05736354 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 who are undergoing breast implant removal or other breast surgeries.
✕Probably not a fit
Patients who are pregnant, immunocompromised, or unable to provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study examines the role of bacterial biofilms in breast implant complications, particularly focusing on Breast Implant Illness (BII). It involves three patient cohorts: those with breast implants and BII symptoms, those with breast implants without symptoms, and individuals who have undergone breast surgery without implants. The study will collect blood, tissue samples, and implant materials to analyze the presence of oxylipins and immune cell responses related to biofilm infections. The goal is to better understand the etiology of complications associated with breast implants.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of complications related to breast implants, potentially enhancing patient outcomes.
How similar studies have gone: While there is limited research on this specific approach, the investigation of bacterial biofilms in medical devices is a growing area of interest, suggesting potential for meaningful insights.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria for breast implant subjects: * Age greater than or equal to 18 years * Undergoing removal of breast implant * Willing and able to comply with protocol instructions Inclusion Criteria for subjects undergoing breast surgeries (other than implant removal) * Age greater than or equal to 18 years * Undergoing breast surgery * Willing and able to comply with protocol instructions Exclusion Criteria: * Individuals who are deemed unable to understand the procedures, risks, and benefits of the study, (i.e., unable to provide informed consent) * Pregnant females * Immunodeficiency (HIV/AIDS, SCID) * Currently on immunosuppressive medications * Prisoners
Where it's running
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IU Health North Hospital
Carmel, Indiana, United States Recruiting -
Meridian Plastic Surgeons
Carmel, Indiana, United States Recruiting -
IU Health Methodist Hospital
Indianapolis, Indiana, United States Recruiting
Study contacts
- Principal investigator: Mithun Sinha, PhD. — Indiana University
- Study coordinator: Mithun Sinha, PhD.
- Email: mitsinha@iu.edu
- Phone: 3172782713
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.