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

University of North Carolina, Chapel Hill · NCT06649890

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
224
US sites recruiting
1
Study start
June 30, 2025
Record last updated
August 7, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Xperience™ Advanced Surgical Irrigation; Dilute Povidone-Iodine

Conditions: Surgical Site Infection; Surgical Complication; Implant Infection; Implant Complication

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • University of North Carolina at Chapel Hill Hospital

    Chapel Hill, NC 27514

    Site contact: Adeyemi Ogunleye, MD · 919-966-4446 · yemi@med.unc.edu

Study contacts (from the official record)

  • Adeyemi Ogunleye, MD · (919) 966-4446 · yemi@med.unc.edu
  • Alethia Burton · 9198435547 · alethia_burton@med.unc.edu
All healthy volunteers studies in North Carolina →
A Novel Surgical Irrigation Solution in Post-Mastectomy… (NCT06649890) | Bored Studies