Breast Implant InfectionPhase 1NCT03213249
Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy
A Phase 1 study testing Normal saline, Cefazolin and Skin biopsy in people with Breast Implant Infection and Mammoplasty, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Breast implants, either cosmetic or reconstructive, are among the most common procedures performed by plastic surgeons. Bacterial infections or biofilms are implicated in the majority of breast implant complications including infection requiring explantation, capsular contracture (CC), and/or breast-implant associated… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Implant Infection, Mammoplasty
- What is being tested?
- Normal saline, Cefazolin and Skin biopsy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2017to 26 Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Between 18 and 75 years of age, inclusive
- Undergoing bilateral mastectomy reconstruction with tissue expanders (ipsilateral therapeutic/contralateral prophylactic) planned to be exchanged for breast implants
- Able to understand and willing to sign an IRB-approved written informed consent document
Who cannot join
- Male
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Breast implants, either cosmetic or reconstructive, are among the most common procedures performed by plastic surgeons. Bacterial infections or biofilms are implicated in the majority of breast implant complications including infection requiring explantation, capsular contracture (CC), and/or breast-implant associated anaplastic large cell lymphoma (BIA-ALCL). The research team, which has already extensively characterized bacterial pathogenesis in the urinary tract and designed non-antibiotic therapeutics to reduce the incidence of catheter-associated urinary tract infections (CAUTIs), and proposal will study bacteria-breast implant interactions and explore further the impact of the breast microbiome. The proposed research provides a greater understanding of which bacteria can colonize breast implants, their source, and how effective antibiotic pocket irrigation is at eliminating them, and begins to examine the mechanisms by which bacteria bind and colonize the implant surface. These insights will set the groundwork for developing new therapeutic agents that can disrupt the binding of certain bacteria to breast implants. Strategies that minimize problems bacteria can cause, while avoiding antibiotics, will reduce bacteria-related implant complications, limit antibiotic-related side effects, and reduce bacterial resistance.
- Conditions
- Breast Implant Infection, Mammoplasty
- Being tested
- Normal saline, Cefazolin, Skin biopsy, Bilateral skin- or nipple-sparing mastectomies, Tissue expander
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineOther
Also called NS
Intraoperative pocket irrigation with normal saline
CefazolinDrug
Also called Ancef
Cefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed
Skin biopsyProcedure or surgery
Biopsies will be taken from the skin at the time of mastectomy and at the time of implant exchange.
Bilateral skin- or nipple-sparing mastectomiesProcedure or surgery
Standard of care
Tissue expanderDevice
Standard of care
Breast implantDevice
- Standard of care
- Either breast implant or autologous flap
Autologous flapProcedure or surgery
- Standard of care
- Either breast implant or autologous flap
Acellular dermal matrix slingOther
Standard of care
GentamicinDrug
Also called Garamycin
Cefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed
BacitracinDrug
Cefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Intraoperative pocket irrigation with NS | Active comparator | * 1 gram cefazolin intravenous before surgical incision
* Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists
* Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling
* Standard of care saline pocket irrigation will receive 500 cc of normal saline alone per pocket. Receives: Other: Normal saline; Procedure: Skin biopsy; Procedure: Bilateral skin- or nipple-sparing mastectomies; Device: Tissue expander; Device: Breast implant; Procedure: Autologous flap; Other: Acellular dermal matrix sling |
| Arm 2: Intraoperative pocket irrigation with NS + antibiotics | Active comparator | * 1 gram cefazolin intravenous before surgical incision
* Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists
* Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling
* Standard of care antibiotic pocket irrigation will receive 500 cc of normal saline plus 1 gram cefazolin, 80 mg gentamicin, and 50,000 units bacitracin Receives: Other: Normal saline; Drug: Cefazolin; Procedure: Skin biopsy; Procedure: Bilateral skin- or nipple-sparing mastectomies; Device: Tissue expander; Device: Breast implant; Procedure: Autologous flap; Other: Acellular dermal matrix sling; Drug: Gentamicin; Drug: Bacitracin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of tissue expander(s) removed due to infection
The bulk of analyses will be to study bacterial biofilm formation on the explanted breast tissue, skin/scar, drain, acellular dermal matrix, tissue expander, and capsule.
Measured: Up to 1 year
Number of tissue expander(s) removed due to patient preference
Measured: Up to 1 year
Secondary outcomes (4)
Duration of implantation
Measured: Up to 1 year
Duration the drain was in
Measured: Up to 1 year
Incidence of development of an infection or a wound
Measured: Up to 1 year
Incidence of capsular contracture
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start25 Jul 2017
- Primary completion26 Sep 2018
- Study completion26 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Implant InfectionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Plastic Surgery Foundation
- Responsible party
- Sponsor
- Investigators
- Terence M Myckatyn, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213249
- Sponsor's protocol ID
- 201704134
- Status last verified
- Feb 2019
- First submitted
- 22 Jun 2017
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy
- ClinicalTrials.gov ID
- NCT03213249
- Acronym / sponsor ID
- 201704134
- Conditions
- Breast Implant Infection, Mammoplasty
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- The Plastic Surgery Foundation
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast implants, either cosmetic or reconstructive, are among the most common procedures performed by plastic surgeons. Bacterial infections or biofilms are implicated in the majority of breast implant complications including infection requiring explantation, capsular contracture (CC), and/or breast-implant associated anaplastic large cell lymphoma (BIA-ALCL). The research team, which has already extensively characterized bacterial pathogenesis in the urinary tract and designed non-antibiotic therapeutics to reduce the incidence of catheter-associated urinary tract infections (CAUTIs), and proposal will study bacteria-breast implant interactions and explore further the impact of the breast microbiome. The proposed research provides a greater understanding of which bacteria can colonize breast implants, their source, and how effective antibiotic pocket irrigation is at eliminating them, and begins to examine the mechanisms by which bacteria bind and colonize the implant surface. These insights will set the groundwork for developing new therapeutic agents that can disrupt the binding of certain bacteria to breast implants. Strategies that minimize problems bacteria can cause, while avoiding antibiotics, will reduce bacteria-related implant complications, limit antibiotic-related side effects, and reduce bacterial resistance.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Intraoperative pocket irrigation with NS | Active comparator | Other: Normal saline, Procedure: Skin biopsy, Procedure: Bilateral skin- or nipple-sparing mastectomies, Device: Tissue expander, Device: Breast implant, Procedure: Autologous flap, Other: Acellular dermal matrix sling* 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care saline pocket irrigation will receive 500 cc of normal saline alone per pocket. |
| Arm 2: Intraoperative pocket irrigation with NS + antibiotics | Active comparator | Other: Normal saline, Drug: Cefazolin, Procedure: Skin biopsy, Procedure: Bilateral skin- or nipple-sparing mastectomies, Device: Tissue expander, Device: Breast implant, Procedure: Autologous flap, Other: Acellular dermal matrix sling, Drug: Gentamicin, Drug: Bacitracin* 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care antibiotic pocket irrigation will receive 500 cc of normal saline plus 1 gram cefazolin, 80 mg gentamicin, and 50,000 units bacitracin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Between 18 and 75 years of age, inclusive
- Undergoing bilateral mastectomy reconstruction with tissue expanders (ipsilateral therapeutic/contralateral prophylactic) planned to be exchanged for breast implants
- Able to understand and willing to sign an IRB-approved written informed consent document
Key exclusion criteria (1 listed)
- Male
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal salineAlso: NSIntraoperative pocket irrigation with normal saline | Other | Arm 1: Intraoperative pocket irrigation with NS, Arm 2: Intraoperative pocket irrigation with NS + antibiotics |
| CefazolinAlso: AncefCefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed | Drug | Arm 2: Intraoperative pocket irrigation with NS + antibiotics |
| Skin biopsyBiopsies will be taken from the skin at the time of mastectomy and at the time of implant exchange. | Procedure or surgery | Arm 1: Intraoperative pocket irrigation with NS, Arm 2: Intraoperative pocket irrigation with NS + antibiotics |
| Bilateral skin- or nipple-sparing mastectomiesStandard of care | Procedure or surgery | Arm 1: Intraoperative pocket irrigation with NS, Arm 2: Intraoperative pocket irrigation with NS + antibiotics |
| Tissue expanderStandard of care | Device | Arm 1: Intraoperative pocket irrigation with NS, Arm 2: Intraoperative pocket irrigation with NS + antibiotics |
| Breast implant* Standard of care * Either breast implant or autologous flap | Device | Arm 1: Intraoperative pocket irrigation with NS, Arm 2: Intraoperative pocket irrigation with NS + antibiotics |
| Autologous flap* Standard of care * Either breast implant or autologous flap | Procedure or surgery | Arm 1: Intraoperative pocket irrigation with NS, Arm 2: Intraoperative pocket irrigation with NS + antibiotics |
| Acellular dermal matrix slingStandard of care | Other | Arm 1: Intraoperative pocket irrigation with NS, Arm 2: Intraoperative pocket irrigation with NS + antibiotics |
| GentamicinAlso: GaramycinCefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed | Drug | Arm 2: Intraoperative pocket irrigation with NS + antibiotics |
| BacitracinCefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed | Drug | Arm 2: Intraoperative pocket irrigation with NS + antibiotics |
Primary outcome
Number of tissue expander(s) removed due to infection
Time frame: Up to 1 year
The bulk of analyses will be to study bacterial biofilm formation on the explanted breast tissue, skin/scar, drain, acellular dermal matrix, tissue expander, and capsule.
Number of tissue expander(s) removed due to patient preference
Time frame: Up to 1 year
4 secondary outcomes
Duration of implantation
Time frame: Up to 1 year
Duration the drain was in
Time frame: Up to 1 year
Incidence of development of an infection or a wound
Time frame: Up to 1 year
Incidence of capsular contracture
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Breast Implant Infection
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 3
Local Antibiotics for Breast Implants
Implant Complication, Implant Infection
RecruitingPhase 4
A Study of Antibiotic Delivery to Prevent Infection After Breast Tissue Expander Placement
Breast Cancer
RecruitingObservational study
Molecular Mechanisms Associated With Breast Implant Complications
Breast Implant; Complications, Infection or Inflammation
RecruitingObservational study
A Registry for People With T-cell Lymphoma
T-cell Lymphoma, NK-Cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terence M Myckatyn, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Normal saline, Cefazolin and Skin biopsy in people with Breast Implant Infection and Mammoplasty, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of tissue expander(s) removed due to infection (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.