Pulsed Lavage in Implant-Based Breast Reconstruction
Pulsed Lavage in Implant-Based Breast Reconstruction: A Randomized Control Trial
University of Alabama at Birmingham
62 participants
Mar 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria3
- Male
- < 18 years of age or > 75 years of age
- Undergoing implant-based breast reconstruction (unilateral or bilateral) with delayed expander at mastectomy
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Interventions
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
Standard of care
Standard of care
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05585710