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

NCT ID: NCT06649890

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2028-06-30

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.

Conditions

Surgical Site Infection; Surgical Complication; Implant Infection; Implant Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Xperience™ Advanced Surgical Irrigation

Group Type: EXPERIMENTAL

Xperience™ Advanced Surgical Irrigation

Intervention Type: DEVICE

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.

Dilute Povidone-Iodine

Group Type: ACTIVE_COMPARATOR

Dilute Povidone-Iodine

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Dilute Betadine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adeyemi Ogunleye, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill Hospital

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Adeyemi Ogunleye, MD

Role: CONTACT

yemi@med.unc.edu

(919) 966-4446

Alethia Burton

Role: CONTACT

alethia_burton@med.unc.edu

9198435547

Facility Contacts

Adeyemi Ogunleye, MD

Role: primary

yemi@med.unc.edu

919-966-4446

Alethia Burton

Role: backup

alethia_burton@med.unc.edu

9198435547

Other Identifiers

24-0853

Identifier Type: -

Identifier Source: org_study_id