Clinical trial NCT05736354: Molecular Mechanisms Associated With Breast Implant Complications
Official title: Molecular Mechanisms Associated With Breast Implant Complications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Implant; Complications
Infection or Inflammation
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2023-02-21
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population focuses on females, ages 18 years or older, that are either undergoing removal of breast implants or undergoing breast surgery. Participants must be willing to comply with protocol instructions and possess the mental capabilities to understand the procedures, risks, and benefits of the study. Additionally, participants that are pregnant will not be eligible for participation. Lastly, participants that are deemed immunodeficient or currently taking immunosuppressive medications will be ineligible for participation.

Brief 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.

Detailed 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.

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 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

Primary outcomes:
measure: Presence of Biofilm in Breast Tissue
timeFrame: Through study completion, an average of 1 year
measure: Analysis of host-biofilm interaction mediated oxylipins from blood
timeFrame: Through study completion, an average of 1 year
measure: Cytokine analysis will be performed on breast tissue
timeFrame: Through study completion, an average of 1 year
measure: Analysis of host-biofilm interaction mediated oxylipins from breast tissue
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: CD4+ Immunological Activation due to Host Implant Interaction
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Carmel
country: United States
facility: IU Health North Hospital
state: Indiana
city: Carmel
country: United States
facility: Meridian Plastic Surgeons
state: Indiana
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Mithun Sinha, PhD.
role: PRINCIPAL_INVESTIGATOR
References: