Pulsed Lavage in Implant-Based Breast Reconstruction

Last updated: April 7, 2025
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Reconstruction

Treatment

Pulsed Lavage Washout

Acellular dermal matrix

Implant-based breast reconstruction

Clinical Study ID

NCT05585710
IRB-300009900
  • Ages 18-75
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Female

  • Between 18 and 75 years of age, inclusive

  • Undergoing implant-based breast reconstruction (unilateral or bilateral) withimmediate expander at mastectomy

  • Able to understand and willing to sign an Institutional Review Board (IRB) approvedwritten informed consent document

Exclusion

Exclusion Criteria:

  • Male

  • < 18 years of age or > 75 years of age

  • Undergoing implant-based breast reconstruction (unilateral or bilateral) withdelayed expander at mastectomy

Study Design

Total Participants: 62
Treatment Group(s): 5
Primary Treatment: Pulsed Lavage Washout
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
August 31, 2026

Study Description

After being informed of the study including potential risks and benefits, all patients giving consent who meet eligibility requirements will undergo randomization into either the pulsed lavage arm (receive mastectomy pocket wash out using pulsed lavage) or the no pulsed lavage arm (pulsed lavage will not be used). Randomization will occur using a random number generator with even numbers resulting in a pulsed lavage washout and odd numbers resulting in no pulsed lavage washout.

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.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Active - Recruiting

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