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Pulsed Lavage in Implant-Based Breast Reconstruction

Pulsed Lavage in Implant-Based Breast Reconstruction: A Randomized Control Trial

Who can join

Ages 18 to 75 · Women

Inclusion Criteria:

* 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 Criteria:

* Male
* \< 18 years of age or \> 75 years of age
* Undergoing implant-based breast reconstruction (unilateral or bilateral) with delayed expander at mastectomy

About the study

To determine if there is any benefit to using pulsed lavage to wash out the mastectomy pocket during breast reconstruction. Primary outcomes will include post-op complications including surgical site infection (SSI), hematoma, seroma, and implant failure.

What is being tested

• Pulsed Lavage Washout (other)
• Implant-based breast reconstruction (procedure)
• Bilateral or unilateral mastectomy (procedure)
• Tissue expander (device)
• Acellular dermal matrix (other)

Sponsor: University of Alabama at Birmingham · Participants: 62 · Started: Mar 1, 2024

Contact the study team

• Ann C Braswell, BS · Phone: 256-595-3846

Official record on ClinicalTrials.gov — NCT05585710

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.