Investigating bacterial biofilms in breast implant complications
Molecular Mechanisms Associated With Breast Implant Complications
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Indiana University Academic / other |
| Locations | 3 sites (Carmel, Indiana and 2 other locations) |
| Trial ID | NCT05736354 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who are undergoing breast implant removal or other breast surgeries.
Not a fit: Patients who are pregnant, immunocompromised, or unable to provide informed consent may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Carmel, Indiana and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.