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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
62
Use of pressurized, pulsed triple antibiotic solution to irrigate mastectomy pocket
Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket
Standard of care
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGPost-op Complications
unintended complications that occur post-surgically
Time frame: up to 3 months
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Standard of care
Standard of care