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Trial record 5 of 29 for:    Recruiting Studies | breast implants

Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy

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ClinicalTrials.gov Identifier: NCT03213249
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : August 2, 2018
Sponsor:
Collaborator:
The Plastic Surgery Foundation
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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 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.

Condition or disease Intervention/treatment Phase
Breast Implant Infection Mammoplasty 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 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy
Actual Study Start Date : July 25, 2017
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Cefazolin

Arm Intervention/treatment
Active Comparator: Arm 1: Intraoperative pocket irrigation with NS
  • 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.
Other: Normal saline
Intraoperative pocket irrigation with normal saline
Other Name: NS

Procedure: Skin biopsy
Biopsies will be taken from the skin at the time of mastectomy and at the time of implant exchange.

Procedure: Bilateral skin- or nipple-sparing mastectomies
Standard of care

Device: Tissue expander
Standard of care

Device: Breast implant
  • Standard of care
  • Either breast implant or autologous flap

Procedure: Autologous flap
  • Standard of care
  • Either breast implant or autologous flap

Other: Acellular dermal matrix sling
Standard of care

Active Comparator: Arm 2: Intraoperative pocket irrigation with NS + antibiotics
  • 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
Other: Normal saline
Intraoperative pocket irrigation with normal saline
Other Name: NS

Drug: Cefazolin
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
Other Name: Ancef

Procedure: Skin biopsy
Biopsies will be taken from the skin at the time of mastectomy and at the time of implant exchange.

Procedure: Bilateral skin- or nipple-sparing mastectomies
Standard of care

Device: Tissue expander
Standard of care

Device: Breast implant
  • Standard of care
  • Either breast implant or autologous flap

Procedure: Autologous flap
  • Standard of care
  • Either breast implant or autologous flap

Other: Acellular dermal matrix sling
Standard of care

Drug: Gentamicin
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
Other Name: Garamycin

Drug: Bacitracin
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




Primary Outcome Measures :
  1. 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.

  2. Number of tissue expander(s) removed due to patient preference [ Time Frame: Up to 1 year ]

Secondary Outcome Measures :
  1. Duration of implantation [ Time Frame: Up to 1 year ]
  2. Duration the drain was in [ Time Frame: Up to 1 year ]
  3. Incidence of development of an infection or a wound [ Time Frame: Up to 1 year ]
  4. Incidence of capsular contracture [ Time Frame: Up to 1 year ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Male

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213249


Contacts
Contact: Terence M Myckatyn, M.D. 314-996-8800 myckatyn@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Terence M Myckatyn, M.D.    314-996-8800    myckatyn@wustl.edu   
Principal Investigator: Terence M Myckatyn, M.D.         
Sub-Investigator: Scott Hultgren, Ph.D.         
Sub-Investigator: Marissa Tenenbaum, M.D.         
Sub-Investigator: Rajiv Parikh, M.D., MPHS         
Sponsors and Collaborators
Washington University School of Medicine
The Plastic Surgery Foundation
Investigators
Principal Investigator: Terence M Myckatyn, M.D. Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03213249     History of Changes
Other Study ID Numbers: 201704134
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Gentamicins
Cefazolin
Bacitracin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Local