A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xperience™ Advanced Surgical Irrigation, Dilute Povidone-Iodine.
- Who it may be relevant to
- Registry conditions: Surgical Site Infection, Surgical Complication, Implant Infection, Implant Complication. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Device 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 - Device 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
Primary outcome measures
- Rate of Surgical Site Infections [Time frame: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.]
Secondary outcome measures (2)
- Rate of Implant Explantation [Time frame: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.]
- Rate of Non-Infectious Post-Surgical Complications [Time frame: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of North Carolina at Chapel Hill Hospital — Chapel Hill
Identifiers
NCT: NCT06649890 · 24-0853