Pulsed Lavage in Implant-Based Breast Reconstruction

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Breast Reconstruction

Clinical Trial Details

NCT number	NCT05585710
Study type	Interventional
Source	University of Alabama at Birmingham
Contact	Ann C Braswell, BS
Phone	256-595-3846
Email	acb98@uab.edu
Status	Recruiting
Phase	N/A
Start date	March 1, 2024
Completion date	August 2025

View Details

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