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NCT05736354 · ClinicalTrials.gov registry record
Molecular Mechanisms Associated With Breast Implant Complications
A clinical trial of Breast Implant; Complications and Infection or Inflammation, sponsored by Indiana University.
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 3
- Study locations
NCT05736354: Recruiting study of Breast Implant; Complications and Infection or Inflammation, sponsored by Indiana University.
NCT05736354 is a study of Breast Implant; Complications and Infection or Inflammation that is actively recruiting participants, run by Indiana University. The registered enrollment target is 1,000 participants. The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05736354, a study of Breast Implant; Complications and Infection or Inflammation, is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
During a clinically scheduled breast surgery, breast tissue specimens will be taken from surgically discarded tissue. The specimens from both breast implant subjects and control subjects (those undergoing breast surgery for a reason other than implant removal) will be analyzed to determine the presence of bacterial biofilm.
Conditions Studied
Study Locations (3)
Indiana
- IU Health North Hospital - Carmel
- Meridian Plastic Surgeons - Carmel
- IU Health Methodist Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2021-01-03 |
| Est. Completion | 2028-06-30 |
What NCT05736354 shows while recruiting
NCT05736354 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 2 conditions, with Breast Implant; Complications appearing as the primary indexed condition, and to 0 interventions.
NCT05736354 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT05736354 about?
NCT05736354 is a clinical study titled "Molecular Mechanisms Associated With Breast Implant Complications". 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 manifestation...
What is the current status of trial NCT05736354?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2021-01-03. Estimated completion is 2028-06-30.
What conditions does trial NCT05736354 study?
This clinical trial studies the following conditions: Breast Implant; Complications, Infection or Inflammation.
Who is sponsoring clinical trial NCT05736354?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05736354 being conducted?
This trial has 3 study locations across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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