Recruiting

Xperience™

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06649890

Conditions

Surgical Site Infection

Surgical Complication

Implant Infection

Implant Complication

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Xperience™ Advanced Surgical Irrigation

Dilute Povidone-Iodine

Study Details

Brief summary:

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.

Conditions

Surgical Site Infection

Surgical Complication

Implant Infection

Implant Complication

Study ID

NCT06649890

Start date

Jun 30, 2025

Status verified date

Jun, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

224 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Xperience™ Advanced Surgical Irrigation

active comparator: Dilute Povidone-Iodine

Interventions

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 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

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.

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 and Locations

Central contacts

Adeyemi Ogunleye, MD

(919) 966-4446yemi@med.unc.edu

Alethia Burton

9198435547alethia_burton@med.unc.edu

Locations

University of North Carolina at Chapel Hill Hospital

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Adeyemi Ogunleye, MD

919-966-4446yemi@med.unc.edu

Alethia Burton

9198435547alethia_burton@med.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Aug 7, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2025-08-07.