An interventional study of Xperience™ Advanced Surgical Irrigation and Dilute Povidone-Iodine in Surgical Site Infection, Surgical Complication and Implant Infection, sponsored by University of North Carolina, Chapel Hill. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
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:
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:
670 studies on the registry are indexed under Surgical Wound Infection; 141 are open to participants now.
This study's planned enrollment of 224 is above the median of 200 across 514 interventional studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Xperience™ Advanced Surgical Irrigation
Device: Dilute Povidone-Iodine
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.
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.
Also known as: Dilute Betadine
Rate of Surgical Site Infections
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.
Time frame: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.
Rate of Implant Explantation
Number of patients who required non-elective implant explantation.
Time frame: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.
Rate of Non-Infectious Post-Surgical Complications
Number of patients who experience the the following, but not limited to, post-surgical complications: * Delayed wound healing (superficial incisional dehiscence requiring serial dressing changes, office debridement and/or operative revision) * Hematoma * Seroma * Tissue expander leak/rupture * Tissue expander/Implant exposure/extrusion
Time frame: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.
Plan to share: No
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University of North Carolina, Chapel Hill