Condition: Surgical Site Infection · Surgical Complication · Implant Infection · Sponsor: University of North Carolina, Chapel Hill
Goal of the Clinical Trial: The purpose of this clinical trial is to learn whether Xperience™ surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections (SSIs) following implant-based breast reconstruction in female patients, aged 18 and older. It will also assess the safety and overall surgical outcomes when using Xperience™ compared to povidone-iodine. Main Questions the Study Aims to Answer: * Does the use of Xperience™ decrease the incidence of surgical site infections compared to povidone-iodine? * What are the differences in the rates of premature implant removal due to infection between patients treated with Xperience™ and those treated with povidone-iodine? * Are there fewer post-surgical complications with Xperience™ compared to povidone-iodine? Study Design: Participants in this study will be randomly assigned to receive either Xperience™ or a dilute povidone-iodine solution during their bilateral implant-based breast reconstruction. Only the research team will know which irrgiation is given- the participant will not know. Participant Will: * Undergo the surgical procedure using one of the two irrigation solutions. * Receive regular post-operative check-ups to monitor for signs of infection and other complications. * Have data collected on any post-surgical complications, the necessity for early implant removal, and overall surgical outcomes.
This description comes directly from the study's public registry record.
Adeyemi Ogunleye, MD · (919) 966-4446 · yemi@med.unc.edu
Alethia Burton · 9198435547 · alethia_burton@med.unc.edu
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| University of North Carolina at Chapel Hill Hospital | Chapel Hill, North Carolina, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06649890