Molecular Mechanisms Associated With Breast Implant Complications
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorIndiana University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 3 trial groupsGroup A: BII Subjects
Group B: Non-BII Subjects
Group C: Subjects without Breast Implants
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, an average of 1 year2
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.
Time frame
Through study completion, an average of 1 year3
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.
Time frame
Through study completion, an average of 1 year4
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.
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
CD4+ Immunological Activation due to Host Implant Interaction
Determining activation of CD4+ immune cells
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov