Xperience™ versus dilute povidone-iodine to prevent infections after implant-based breast reconstruction
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
This trial will test whether Xperience™ surgical irrigation reduces infection and complication rates compared with dilute povidone-iodine in women 18 and older having implant-based breast reconstruction after mastectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06649890 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adult women (18+) planning bilateral/double mastectomy followed by implant-based reconstruction (immediate, delayed, or second-stage exchange) who can attend follow-up visits at UNC Chapel Hill are ideal candidates.
Not a fit: Patients undergoing unilateral mastectomy, autologous reconstruction, those with known sensitivity to solution components, or those unable to complete follow-up (including expanders placed outside the UNC system) are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, Xperience™ could lower surgical site infections and reduce the need for premature implant removal, improving recovery and outcomes after reconstruction.
How similar studies have performed: Povidone-iodine irrigation has been used with mixed results in prior work, and dedicated commercial irrigation solutions like Xperience™ are less well-studied, making this approach relatively novel in this specific setting.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chapel Hill, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.