A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Oct 17, 2024
Trial Information
Current as of May 08, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new surgical irrigation solution called Xperience™ to see if it can help reduce the risk of infections after breast reconstruction surgery in women. Specifically, the trial aims to find out if Xperience™ is better than a common solution called dilute povidone-iodine at preventing surgical site infections and other complications that can occur after surgery. Women aged 18 and older who are having a double mastectomy followed by breast reconstruction may be eligible to participate.
If you choose to join the study, you will be randomly assigned to receive either Xperience™ or the standard solution during your surgery, but you won't know which one you're getting. After your surgery, you'll have regular check-ups to monitor for any signs of infection or complications. The study will collect information on your recovery and any issues that arise, such as the need to remove an implant early due to infection. This trial is not recruiting participants yet, but it aims to help improve surgical outcomes for women undergoing breast reconstruction.
Gender
FEMALE
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
About University Of North Carolina, Chapel Hill
The University of North Carolina at Chapel Hill (UNC) is a leading research institution renowned for its commitment to advancing health and science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, UNC conducts cutting-edge research across various fields, including medicine, public health, and biomedical sciences. The university is dedicated to improving patient care and health outcomes by translating its research findings into practical applications. UNC’s clinical trials are designed to evaluate new therapies, interventions, and technologies, ensuring that they meet the highest ethical and scientific standards while fostering a culture of inclusivity and community engagement.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chapel Hill, North Carolina, United States
Patients applied
Trial Officials
Adeyemi Ogunleye, MD
Principal Investigator
University of North Carolina, Chapel Hill
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported