NCT05585710

Pulsed Lavage in Implant-Based Breast Reconstruction

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Reconstruction

Interventions

Type	Name	Description
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
PROCEDURE	Bilateral or unilateral mastectomy	Standard of care
DEVICE	Tissue expander	Standard of care
OTHER	Acellular dermal matrix	Standard of care

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-03-01
• Completion: 2026-08-01
• First posted: 2022-10-19
• Last updated: 2025-04-10

Locations

1 site across 1 country: United States