Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
62 participants
INTERVENTIONAL
2024-03-01
2026-08-31
Brief Summary
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Detailed Description
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The patients will be followed in clinic for a maximum of 3 months to evaluate the surgical site. The two cohorts will be compared at the end of the study to determine whether there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Pulsed Lavage Washout
This cohort will undergo standard of care bilateral or unilateral mastectomies as determined by breast surgical oncologists and immediate standard of care breast reconstruction with tissue expander placement and pulsed lavage washout.
Pulsed Lavage Washout
Use of pressurized, pulsed triple antibiotic solution to irrigate mastectomy pocket
Implant-based breast reconstruction
Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket
Bilateral or unilateral mastectomy
Standard of care
Tissue expander
Standard of care
Acellular dermal matrix
Standard of care
No Pulsed Lavage
This cohort will undergo standard of care bilateral or unilateral mastectomies as determined by breast surgical oncologists and immediate standard of care breast reconstruction with tissue expander placement.
Implant-based breast reconstruction
Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket
Bilateral or unilateral mastectomy
Standard of care
Tissue expander
Standard of care
Acellular dermal matrix
Standard of care
Interventions
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Pulsed Lavage Washout
Use of pressurized, pulsed triple antibiotic solution to irrigate mastectomy pocket
Implant-based breast reconstruction
Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket
Bilateral or unilateral mastectomy
Standard of care
Tissue expander
Standard of care
Acellular dermal matrix
Standard of care
Eligibility Criteria
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Inclusion Criteria
* Between 18 and 75 years of age, inclusive
* Undergoing implant-based breast reconstruction (unilateral or bilateral) with immediate expander at mastectomy
* Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document
Exclusion Criteria
* \< 18 years of age or \> 75 years of age
* Undergoing implant-based breast reconstruction (unilateral or bilateral) with delayed expander at mastectomy
18 Years
75 Years
FEMALE
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Richard Jobe Fix
Professor in the Department of Plastic Surgery
Principal Investigators
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Richard J Fix, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-300009900
Identifier Type: -
Identifier Source: org_study_id
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