Pulsed Lavage in Implant-Based Breast Reconstruction

NCT05585710 | Recruiting

• 1 other identifier: IRB-300009900
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Keywords

breast reconstruction; implant-based breast reconstruction; pulsed lavage

Outcome Measures

Primary Outcomes (1)

• Post-op Complications

  unintended complications that occur post-surgically

  up to 3 months

Study Arms (2)

Pulsed Lavage Washout

EXPERIMENTAL

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.

Other: Pulsed Lavage Washout; Procedure: Implant-based breast reconstruction; Procedure: Bilateral or unilateral mastectomy; Device: Tissue expander; Other: Acellular dermal matrix

No Pulsed Lavage

ACTIVE COMPARATOR

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.

Procedure: Implant-based breast reconstruction; Procedure: Bilateral or unilateral mastectomy; Device: Tissue expander; Other: Acellular dermal matrix

Interventions

Pulsed Lavage Washout OTHER

Use of pressurized, pulsed triple antibiotic solution to irrigate mastectomy pocket

Pulsed Lavage Washout

Implant-based breast reconstruction PROCEDURE

Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket

No Pulsed Lavage; Pulsed Lavage Washout

Bilateral or unilateral mastectomy PROCEDURE

Standard of care

No Pulsed Lavage; Pulsed Lavage Washout

Tissue expander DEVICE

Standard of care

No Pulsed Lavage; Pulsed Lavage Washout

Acellular dermal matrix OTHER

Standard of care

No Pulsed Lavage; Pulsed Lavage Washout

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Interventions

Mastectomy, Simple; Tissue Expansion Devices

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative; Prostheses and Implants; Equipment and Supplies; Surgical Equipment

Study Officials

• Richard J Fix, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann C Braswell, BS

CONTACT

256-595-3846; acb98@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Pulsed Lavage is a surgical technique that cannot be masked from the investigators performing the operation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in the Department of Plastic Surgery

Model Details: Two cohorts will be established. One cohort will include patients who undergo pulsed lavage to wash out the mastectomy pocket. The other cohort will include patients who do not receive pulsed lavage.

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 19, 2022
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)