Pulsed Lavage in Implant-Based Breast Reconstruction
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.
| Condition(s) | Breast Reconstruction |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Lead sponsor | University of Alabama at Birmingham |
| Locations | Birmingham, Alabama, United States |
| Start date | 2024-03-01 |
| NCT ID | NCT05585710 |
| Official listing | https://clinicaltrials.gov/study/NCT05585710 |