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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06649890
Status
Recruiting
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Conditions

  • Implant Complication
  • Implant Infection
  • Surgical Complication
  • Surgical Site Infection

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Xperience™ Advanced Surgical Irrigation — DEVICE
    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 insertion, with a 5-minute dwell time. Excess solution will be suctioned throughout, and no rinsing will occur post-irrigation. Surgical site closure will follow standard procedures.
  • Dilute Povidone-Iodine — DEVICE
    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 suctioned throughout. Surgeon discretion will determine rinsing after irrigation. Surgical site closure will follow standard procedures.

Study Details

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.

Key Dates

Start date
Jun 30, 2025
Status verified
Jun 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
224 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Xperience™ Advanced Surgical Irrigation
  • Active Comparator: Dilute Povidone-Iodine

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel Hill HospitalChapel HillNorth Carolina27514
Adeyemi Ogunleye, MD
[email protected]
919-966-4446
Alethia Burton
[email protected]
9198435547
Grace A Longfellow, BS (SUB_INVESTIGATOR)
Christina Kapsalis, MD (SUB_INVESTIGATOR)

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University of North Carolina at Chapel Hill Hospital· Chapel Hill, NC

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