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Evaluating Xperience™ for Post-Mastectomy Reconstruction

This study is testing if a new surgical wash, Xperience™ Advanced Surgical Irrigation, can better prevent infections after breast reconstruction surgery compared to a standard dilute povidone-iodine solution. Researchers want to see if Xperience™ leads to fewer surgical site infections (SSIs) and reduces the need to remove implants early due to infection. You may be able to join if you are a woman over 18 years old who is having a double mastectomy followed by breast reconstruction with tissue expanders or implants. The study aims to enroll 224 participants. The current status of the study is unclear.

Study design
This is an interventional study comparing Xperience™ Advanced Surgical Irrigation to dilute povidone-iodine in about 224 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will check for surgical site infections within 90 days of your implant or tissue expander placement.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06649890

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

Recruiting
NAAges 18+InterventionalPrevention
University of North Carolina, Chapel Hill
~224 participants
Updated 2025-08-07 on ClinicalTrials.gov
What's tested:Xperience™ Advanced Surgical IrrigationDilute Povidone-Iodine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Surgical Site Infections
Measured over Within 90 days of implant/tissue expander placement, with the day of placement Day 0.

Conditions

Surgical Site Infection
Surgical Complication
Implant Infection
Implant Complication

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Adeyemi Ogunleye, MD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill

Who to contact

Adeyemi Ogunleye, MD
[email protected]
(919) 966-4446
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Rate of Surgical Site InfectionsWithin 90 days of implant/tissue expander placement, with the day of placement Day 0.

    Number of patients diagnosed with surgical site infections as per the diagnostic criteria outlined by the Centers for Disease Control National Healthcare Safety Network's 2024 Breast Surgery (BRST) Surgical Site Infection Criteria.