Molecular Mechanisms Associated With Breast Implant Complications
NCT05736354
This study is recruiting at 3 US sites in 1 state, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Breast Implant; Complications
- Infection or Inflammation
Eligibility basics and study details
- Study type
- Observational
- Phase
- Not applicable
- Ages
- 18 years and older
- Sex
- Female
- Healthy volunteers
- Not accepted
- Sponsor
- Indiana University
- Last updated on ClinicalTrials.gov
- June 11, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Indiana · 3
- IU Health North Hospital · Carmel, IN
- Meridian Plastic Surgeons · Carmel, IN
- IU Health Methodist Hospital · Indianapolis, IN
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.