Molecular Mechanisms Associated With Breast Implant Complications
Recruiting
Observational Study
Breast Implant; Complications
Infection or Inflammation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Observational
- Participants needed
- 1,000 (estimated)
- Sponsor
- Indiana University · Other
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About This Trial
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 …
Trial Locations
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Eligibility 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 equ…
Contacts