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

RecruitingNAAges 18 Years - anyFemaleUniversity of North Carolina, Chapel Hill
NCT06649890 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Older than 18 years old * Willing to comply with all study-related procedures * Available for the duration of the study * Participants undergoing double mastectomy surgery followed by one of the following: (1) Immediate reconstruction with tissue expander placement, (2) Delayed reconstruction with tissue expander or implant placement, (3) Immediate reconstruction with implant placement, (4) Second-stage reconstruction with tissue expander to implant exchange Exclusion Criteria: * Participants unable to participate in follow-up visits * Participants undergoing unilateral mastectomy * Tissue expanders placed by a surgeon outside of the UNC Chapel Hill Hospital System * Undergoing autologous reconstruction * Participant is unable to provide signed and dated informed consent * Unwilling or unable to comply with all study-related procedures. * Known history of sensitivity or allergic reaction to any of the components of the Xperience™ irrigation solution or dilute povidone-iodine irrigation * Participant with any conditions that would be a contraindication to receiving surgery such as contraindications to general anesthesia * Pregnant, planning to become pregnant or breast feeding participants * Individuals providing informed consent with any mental impairment or condition that would make them unable to properly consent without use of legally authorized representative (LAR) or additional participant protections. * Incarcerated participants
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What it tests

  • Xperience™ Advanced Surgical Irrigation
  • Dilute Povidone-Iodine
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Where

1 site
University of North Carolina at Chapel Hill Hospital
Chapel Hill, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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