Actively Recruiting
A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
Led by University of North Carolina, Chapel Hill · Updated on 2025-08-07
224
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Older than 18 years old
- Willing to comply with all study-related procedures
- Available for the duration of the study
- Undergoing double mastectomy surgery with one of the following reconstruction methods: immediate tissue expander placement, delayed tissue expander or implant placement, immediate implant placement, or second-stage tissue expander to implant exchange
You will not qualify if you...
- Unable to participate in follow-up visits
- Undergoing unilateral mastectomy
- Tissue expanders placed by a surgeon outside UNC Chapel Hill Hospital System
- Undergoing autologous reconstruction
- Unable to provide signed informed consent
- Unwilling or unable to comply with study procedures
- Known allergy to Xperience™ irrigation solution or povidone-iodine
- Conditions contraindicating surgery or general anesthesia
- Pregnant, planning pregnancy, or breastfeeding
- Mental impairment preventing proper consent without legal representative
- Incarcerated individuals
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill Hospital
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
Research Team
A
Adeyemi Ogunleye, MD
CONTACT
A
Alethia Burton
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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