Pulsed Lavage in Implant-Based Breast Reconstruction

This study is looking at whether using a special wash called "pulsed lavage washout" during implant-based breast reconstruction helps reduce problems after surgery. Pulsed lavage uses a pressurized, pulsed triple antibiotic solution to clean the mastectomy (breast removal) pocket. The study wants to see if this method is better than the standard way of cleaning, which uses a bulb syringe with a triple antibiotic solution. You might be able to join if you are a woman between 18 and 75 years old, having implant-based breast reconstruction with an immediate tissue expander (a device used to prepare the breast for an implant). The main goal is to see if pulsed lavage reduces complications like infections, bleeding, fluid buildup, or implant failure within three months after surgery. The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 62 participants. You would be randomly assigned to either receive the pulsed lavage washout or the standard cleaning method.
What's involved
You would undergo either the pulsed lavage washout or the standard cleaning during your breast reconstruction surgery. You will then have follow-up visits.
Compensation
Not stated in the trial record.
Follow-up
You will be followed in the clinic for a maximum of 3 months after your surgery to check for complications.

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NCT05585710

Pulsed Lavage in Implant-Based Breast Reconstruction

Recruiting
NAAges 18–75InterventionalPrevention
University of Alabama at Birmingham
~62 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:Pulsed Lavage WashoutImplant-based breast reconstructionBilateral or unilateral mastectomyTissue expanderAcellular dermal matrix

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Post-op Complications
Measured over up to 3 months
Breast Reconstruction
1 sites across 1 states
Alabama1
  • Richard J Fix, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

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Eligibility criteria

Inclusion

Female
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

Male
\< 18 years of age or \> 75 years of age
Undergoing implant-based breast reconstruction (unilateral or bilateral) with delayed expander at mastectomy
  • Post-op Complicationsup to 3 months

    unintended complications that occur post-surgically