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| ID | Type | Description | Link |
|---|---|---|---|
| R21AI171932 | U.S. NIH Grant/Contract | View source | |
| R01AI165958 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| CD4+ Immunological Activation due to Host Implant Interaction | Determining activation of CD4+ immune cells | Through study completion, an average of 1 year |
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Inclusion Criteria for breast implant subjects:
Inclusion Criteria for subjects undergoing breast surgeries (other than implant removal)
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mithun Sinha, PhD. | Contact | 3172782713 | mitsinha@iu.edu | |
| Bryce Hockman | Contact | 3172782715 | bbhockma@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mithun Sinha, PhD. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health North Hospital | Recruiting | Carmel | Indiana | 46032 | United States |
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| ID | Term |
|---|---|
| D007239 | Infections |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
| Meridian Plastic Surgeons | Recruiting | Carmel | Indiana | 46290 | United States |
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| IU Health Methodist Hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
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