Pulsed Lavage in Implant-Based Breast Reconstruction: A Randomized Control Trial
University of Alabama at Birmingham
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.
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 wil…
Eligibility
- Age range
- 18–75 years
- Sex
- Female
- Healthy volunteers
- No
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
Interventions
- OtherPulsed Lavage Washout
Use of pressurized, pulsed triple antibiotic solution to irrigate mastectomy pocket
- ProcedureImplant-based breast reconstruction
Standard of care; use of triple antibiotic solution delivered via bulb syringes to irrigate mastectomy pocket
- ProcedureBilateral or unilateral mastectomy
Standard of care
- DeviceTissue expander
Standard of care
- OtherAcellular dermal matrix
Standard of care
Location
- University of Alabama at BirminghamBirmingham, Alabama