Comparing Xperience Surgical Irrigation to Dilute Povidone-Iodine in Preventing Infections and Improving Outcomes After Implant-Based Breast Reconstruction in Women

What this Trial Is About

Researchers are evaluating whether the Xperience surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections following implant-based breast reconstruction in women aged 18 and older. The study also aims to compare the safety and overall surgical outcomes between Xperience and povidone-iodine. This clinical trial is a randomized controlled trial sponsored by the University of North Carolina, Chapel Hill. Participants will be randomly assigned to receive either the Xperience solution or the dilute povidone-iodine solution during their bilateral implant-based breast reconstruction surgery. Xperience will be applied twice during the procedure, soaking both the mastectomy pockets and implants with specific volumes and dwell times before insertion. The povidone-iodine solution will be applied similarly. Surgical site closure will follow standard procedures for all participants. During the study, participants will have regular post-operative check-ups to monitor for infections and other complications. Researchers will collect data on the rates of surgical site infections, premature implant removal due to infection, and non-infectious post-surgical complications within 90 days after implant placement. The study will monitor safety and overall outcomes through these evaluations, with participation lasting through this 90-day post-surgery period.

A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™