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

Официальное название

A Randomized Control Trial Evaluating the Efficacy of Xperience™ Surgical Irrigation Solution Versus Dilute Povidone-Iodine in Preventing Surgical Site Infections and Improving Postoperative Outcomes in Implant-Based Breast Reconstruction

Обзор

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.

Вмешательства

• Устройство Xperience™ Advanced Surgical Irrigation
  Xperience™ solution will be applied twice during reconstruction procedures: first after achieving hemostasis and second just before implant introduction. The solution will be warmed to body temperature before use. Both tissue expanders/implants and mastectomy pockets will be soaked with Xperience™, using sterile syringes. A 1-minute dwell time with a total volume of 500 mL per mastectomy pocket will be employed, twice. Additionally, 500 mL of Xperience™ will be applied to implants before inserti
• Устройство Dilute Povidone-Iodine
  5% dilute povidone-iodine solution will be prepared by mixing povidone-iodine solution and normal saline at the appropriate ratio. Both tissue expanders/implants and mastectomy pockets will be soaked with dilute povidone-iodine, using sterile syringes. A 1-minute dwell time with a total volume of 500 mL per mastectomy pocket will be employed, twice. Additionally, 500 mL of dilute povidone-iodine will be applied to implants before insertion, with a 5-minute dwell time. Excess solution will be suc

Первичные конечные точки

• Rate of Surgical Site Infections [Срок оценки: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.]

Вторичные конечные точки (2)

• Rate of Implant Explantation [Срок оценки: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.]
• Rate of Non-Infectious Post-Surgical Complications [Срок оценки: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of North Carolina at Chapel Hill Hospital — Chapel Hill

Идентификаторы

NCT: NCT06649890 · 24-0853

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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