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

NCT06649890 | Recruiting FDA Device

• 1 other identifier: 24-0853
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 90 days of implant/tissue expander placement, with the day of placement Day 0.

Secondary Outcomes (2)

• Rate of Implant Explantation

  Within 90 days of implant/tissue expander placement, with the day of placement Day 0.

• Rate of Non-Infectious Post-Surgical Complications

  Within 90 days of implant/tissue expander placement, with the day of placement Day 0.

Study Arms (2)

Xperience™ Advanced Surgical Irrigation

EXPERIMENTAL

Device: Xperience™ Advanced Surgical Irrigation

Dilute Povidone-Iodine

ACTIVE COMPARATOR

Device: Dilute Povidone-Iodine

Interventions

Xperience™ Advanced Surgical Irrigation 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.

Xperience™ Advanced Surgical Irrigation

Dilute Povidone-Iodine 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.

Also known as: Dilute Betadine

Dilute Povidone-Iodine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill Hospital

Chapel Hill, North Carolina, 27514, United States

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adeyemi Ogunleye, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adeyemi Ogunleye, MD

CONTACT

(919) 966-4446; yemi@med.unc.edu

Alethia Burton

CONTACT

9198435547; alethia_burton@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: October 21, 2024
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 7, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)