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

NARecruitingINTERVENTIONAL
Enrollment

224

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

June 30, 2028

Study Completion Date

June 30, 2028

Conditions
Surgical Site InfectionSurgical ComplicationImplant InfectionImplant Complication
Interventions
DEVICE

Xperience™ Advanced Surgical Irrigation

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.

DEVICE

Dilute Povidone-Iodine

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.

Trial Locations (1)

27514

RECRUITING

University of North Carolina at Chapel Hill Hospital, Chapel Hill

All Listed Sponsors
lead

University of North Carolina, Chapel Hill

OTHER