Molecular Mechanisms Associated With Breast Implant Complications

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Breast implants were first introduced in 1962. It is estimated that 10 million women worldwide, including three million Americans have breast implants. There has been increased identification of patients experiencing a constellation of symptoms related to their implants. For breast implants, these symptoms are often associated with autoimmune and connective tissue disorders (CTD) and have been referred to as Breast Implant Illness (BII). A growing number of patients 30,000 annually are seeking to have their breast implants removed. In view of the implant associated complications, the US Food and Drug Administration (FDA) has placed a black box warning on breast implants. Limited research has resulted in a void in the prognosis of this surgical problem. Bacterial biofilms are becoming a major concern for medical device implants. 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 BII. This research studies oxilidized lipids (oxylipins). These are metabolities formed as a result of host-biofilm interaction. The presence of oxylipins will be studied in peri-prosthetic tissue post-biofilm infection and in systemic circulation. Oxylipins are immunogenic. Hence, the investigators will also study the abundance of immune cells T cells and macrophages (types and subtypes) and associated cytokines. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05736354
Study type	Observational
Source	Indiana University
Contact	Mithun Sinha, PhD.
Phone	3172782713
Email	mitsinha@iu.edu
Status	Recruiting
Phase
Start date	January 3, 2021
Completion date	June 30, 2028

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Molecular Mechanisms Associated With Breast Implant Complications — MMABIC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms