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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1
University of North Carolina at Chapel Hill Hospital
Chapel Hill, North Carolina, United States, 27514