Pulsed Lavage in Implant-Based Breast Reconstruction

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Reconstruction
• Intervention / Treatment: Device: Tissue expander; Procedure: Bilateral or unilateral mastectomy; Other: Acellular dermal matrix; Other: Pulsed Lavage Washout; Procedure: Implant-based breast reconstruction

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ann C Braswell, BS; Phone Number: 256-595-3846; Email: acb98@uab.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
      • Principal Investigator: Richard J Fix, MD
      • Contact: Ann C Braswell, BS; Phone Number: 2565953846; Email: acb98@uab.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Tissue expander; Standard of care; Procedure: Bilateral or unilateral mastectomy; Standard of care; Other: Acellular dermal matrix; Standard of care; Other: Pulsed Lavage Washout; Use of pressurized, pulsed triple antibiotic solution to irrigate mastectomy pocket; Procedure: Implant-based breast reconstruction; Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket
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.	Device: Tissue expander; Standard of care; Procedure: Bilateral or unilateral mastectomy; Standard of care; Other: Acellular dermal matrix; Standard of care; Procedure: Implant-based breast reconstruction; Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-op Complications	unintended complications that occur post-surgically	up to 3 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Richard J Fix, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 14, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: breast reconstruction; pulsed lavage; implant-based breast reconstruction
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Surgical Equipment; Equipment and Supplies; Mastectomy; Prostheses and Implants; Tissue Expansion Devices; Mastectomy, Simple
• Other Study ID Numbers: IRB-300009900; UAB (Other Identifier: UAB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No