Clinical trial NCT03213249: Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy
Official title: Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Implant Infection
Mammoplasty
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Plastic Surgery Foundation
First posted: 2017-07-11
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: Number of tissue expander(s) removed due to infection
timeFrame: Up to 1 year
measure: Number of tissue expander(s) removed due to patient preference
timeFrame: Up to 1 year
Secondary outcomes:
measure: Duration of implantation
timeFrame: Up to 1 year
measure: Duration the drain was in
timeFrame: Up to 1 year
measure: Incidence of development of an infection or a wound
timeFrame: Up to 1 year
measure: Incidence of capsular contracture
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Terence M Myckatyn, M.D.
role: PRINCIPAL_INVESTIGATOR
References: