Xperience™ versus dilute povidone-iodine to prevent infections after implant-based breast reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional study assigns participants to receive either Xperience™ advanced surgical irrigation or a standard dilute povidone-iodine solution during implant-based breast reconstruction. The team will track surgical site infections, premature implant removals due to infection, and other postoperative complications, while monitoring safety outcomes. Eligible participants include adults undergoing bilateral/double mastectomy with immediate, delayed, or second-stage tissue expander/implant reconstruction at the UNC Chapel Hill system. Follow-up visits at the study site will be used to collect outcome and safety data.

Why it matters

Who can join: the full rules

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

Where it's running

• University of North Carolina at Chapel Hill Hospital
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Adeyemi Ogunleye, MD — University of North Carolina, Chapel Hill
• Study coordinator: Adeyemi Ogunleye, MD
• Email: yemi@med.unc.edu
• Phone: (919) 966-4446

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.