Pulsed Lavage in Implant-Based Breast Reconstruction

Not Applicable

Recruiting

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

• Registration Number: NCT05585710
• Lead Sponsor: University of Alabama at Birmingham

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.

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 Timeline

• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-19
• Study Start: 2024-03-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-03
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 62

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulsed Lavage Washout	Tissue expander	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.
Pulsed Lavage Washout	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.
No Pulsed Lavage	Bilateral or unilateral mastectomy	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.
Pulsed Lavage Washout	Acellular dermal matrix	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.
No Pulsed Lavage	Implant-based breast reconstruction	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.
Pulsed Lavage Washout	Implant-based breast reconstruction	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.
Pulsed Lavage Washout	Bilateral or unilateral mastectomy	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.
No Pulsed Lavage	Tissue expander	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.
No Pulsed Lavage	Acellular dermal matrix	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.

Primary Outcome Measures

Name	Time	Method
Post-op Complications	up to 3 months	unintended complications that occur post-surgically

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States