Status:

RECRUITING

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

Lead Sponsor:

University of North Carolina, Chapel Hill

Conditions:

Surgical Site Infection

Surgical Complication

Eligibility:

FEMALE

18+ years

Phase:

NA

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 reducin...

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

Key Trial Info

Start Date :

June 30 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2028

Estimated Enrollment :

224 Patients enrolled

Trial Details

Trial ID

NCT06649890

Start Date

June 30 2025

End Date

June 30 2028

Last Update

August 7 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of North Carolina at Chapel Hill Hospital

Chapel Hill, North Carolina, United States, 27514