Recruiting

Pulsed Lavage

Sponsor:

University of Alabama at Birmingham

Code:

NCT05585710

Conditions

Breast Reconstruction

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pulsed Lavage Washout

Implant-based breast reconstruction

Bilateral or unilateral mastectomy

Tissue expander

Acellular dermal matrix

Study Details

Brief 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.

Conditions

Breast Reconstruction

Study ID

NCT05585710

Start date

Mar 1, 2024

Status verified date

May, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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

Primary outcome measure

  • Post-op Complications [ Time Frame: up to 3 months ]

Central Contacts and Locations

Central contacts

Ann C Braswell, BS

256-595-3846acb98@uab.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Ann C Braswell, BS

2565953846acb98@uab.edu

Principal Investigator:

Richard J Fix, MD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • breast reconstruction
  • implant-based breast reconstruction
  • pulsed lavage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-05-18.