Pulsed Lavage in Implant-Based Breast Reconstruction
Start Date
3/1/2024
Completion Date
8/1/2027
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.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
Pulsed Lavage Washout
Implant-based breast reconstruction
Bilateral or unilateral mastectomy
Tissue expander
Acellular dermal matrix
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States