Actively Recruiting
A Randomized Control Trial Evaluating the Efficacy of Xperience™ Surgical Irrigation Solution Versus Dilute Povidone-Iodine in Preventing Surgical Site Infections and Improving Postoperative Outcomes in Implant-Based Breast Reconstruction
Led by University of North Carolina, Chapel Hill · Updated on 2025-08-07
224
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether the Xperience™ surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections following implant-based breast reconstruction in women aged 18 and older. The study also aims to compare the safety and overall surgical outcomes between Xperience™ and povidone-iodine. This clinical trial is a randomized controlled trial sponsored by the University of North Carolina, Chapel Hill. Participants will be randomly assigned to receive either the Xperience™ solution or the dilute povidone-iodine solution during their bilateral implant-based breast reconstruction surgery. Xperience™ will be applied twice during the procedure, soaking both the mastectomy pockets and implants with specific volumes and dwell times before insertion. The povidone-iodine solution will be applied similarly. Surgical site closure will follow standard procedures for all participants. During the study, participants will have regular post-operative check-ups to monitor for infections and other complications. Researchers will collect data on the rates of surgical site infections, premature implant removal due to infection, and non-infectious post-surgical complications within 90 days after implant placement. The study will monitor safety and overall outcomes through these evaluations, with participation lasting through this 90-day post-surgery period.
CONDITIONS
Brief Title
A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, 18 years of age or older
- Willing to comply with all study-related procedures
- Available for the full duration of the study
- Undergoing bilateral mastectomy followed by one of the following: immediate reconstruction with tissue expander placement, delayed reconstruction with tissue expander or implant placement, immediate reconstruction with implant placement, or second-stage reconstruction with 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 of the UNC Chapel Hill Hospital System
- Undergoing autologous reconstruction
- Unable to provide signed and dated informed consent
- Unwilling or unable to comply with study procedures
- Known sensitivity or allergic reaction to components of Xperience™ or dilute povidone-iodine
- Conditions contraindicating surgery such as contraindications to general anesthesia
- Pregnant, planning to become pregnant, or breastfeeding
- Mental impairment preventing proper consent without legally authorized representative
- Incarcerated individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0 (surgery day)
Participants undergo bilateral mastectomy followed by implant-based breast reconstruction using either the Xperience™ Advanced Surgical Irrigation or Dilute Povidone-Iodine solution during surgery.
1 surgical visit
Duration - Up to 90 days after surgery
Participants are monitored for surgical site infections, implant explantation, and non-infectious post-surgical complications following reconstruction.
Follow-up visits as scheduled during 90 days post-surgery
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
A
Alethia Burton
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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