Molecular Mechanisms Associated With Breast Implant Complications
MMABIC
3 other identifiers
observational
1,000
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 3, 2021
CompletedFirst Submitted
Initial submission to the registry
January 17, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
April 10, 2025
April 1, 2025
7.5 years
January 17, 2023
April 8, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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
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
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
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 Outcomes (1)
CD4+ Immunological Activation due to Host Implant Interaction
Through study completion, an average of 1 year
Study Arms (3)
BII Subjects
Subjects with breast implants having BII manifestations.
Non-BII Subjects
Subjects with breast implants with no reported BII symptoms.
Subjects without Breast Implants
Subjects without breast implants.
Eligibility Criteria
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.
You may qualify if:
- Age greater than or equal to 18 years
- Undergoing removal of breast implant
- Willing and able to comply with protocol instructions
- Age greater than or equal to 18 years
- Undergoing breast surgery
- Willing and able to comply with protocol instructions
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
IU Health North Hospital
Carmel, Indiana, 46032, United States
Meridian Plastic Surgeons
Carmel, Indiana, 46290, United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
Biospecimen
Surgically discarded samples (implants, associated capsule, and tissue). For control participants, adipose tissue will be collected which will be removed during implant placement. 20 mL of blood will be collected at the time of pre-operative surgical preparation.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mithun Sinha, PhD.
Indiana University School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 17, 2023
First Posted
February 21, 2023
Study Start
January 3, 2021
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
April 10, 2025
Record last verified: 2025-04