Molecular Mechanisms Associated With Breast Implant Complications

Breast Implant; Complications Clinical Trial

— MMABIC  

Official title:

Molecular Mechanisms Associated With Breast Implant Complications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05736354
• Other study ID #: 2003674175
• Secondary ID: R21AI171932R01AI
• Status: Recruiting
• Start date: January 3, 2021
• Est. completion date: June 30, 2028

Study information

• Verified date: March 2024
• Source: Indiana University
• Contact: Mithun Sinha, PhD.
• Phone: 3172782713
• Email: mitsinha[@]iu.edu
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Implant; Complications
• Inflammation

Locations

Country	Name	City	State
United States	IU Health North Hospital	Carmel	Indiana
United States	Meridian Plastic Surgeons	Carmel	Indiana
United States	IU Health Methodist Hospital	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of Biofilm in Breast Tissue	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.	Through study completion, an average of 1 year
Primary	Analysis of host-biofilm interaction mediated oxylipins from blood	Prior to a clinically scheduled breast surgery, 20 milliliters of blood will be collected during the pre-operative surgical preparations. The blood samples from both breast implant subjects and control subjects (those undergoing breast surgery for a reason other than implant removal) will be analyzed for host-biofilm interaction mediated oxylipins.	Through study completion, an average of 1 year
Primary	Cytokine analysis will be performed on breast tissue	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 undergo cytokine analysis.	Through study completion, an average of 1 year
Primary	Analysis of host-biofilm interaction mediated oxylipins from breast tissue	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 undergo oxylipin analysis.	Through study completion, an average of 1 year
Secondary	CD4+ Immunological Activation due to Host Implant Interaction	Determining activation of CD4+ immune cells	Through study completion, an average of 1 year