NCT06649890 A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
| NCT ID | NCT06649890 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Surgical Site Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 224 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 224 participants in total. It began in 2025-06-30 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Adeyemi Ogunleye, MD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06649890 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Surgical Site Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06649890 currently recruiting?
Yes, NCT06649890 is actively recruiting participants. Contact the research team at yemi@med.unc.edu for enrollment information.
Where is the NCT06649890 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06649890 clinical trial?
NCT06649890 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Adeyemi Ogunleye, MD at University of North Carolina, Chapel Hill. The trial plans to enroll 224 participants.