RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-30
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06649890

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Older than 18 years old
  2. * Willing to comply with all study-related procedures
  3. * Available for the duration of the study
  4. * 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
  1. * Participants unable to participate in follow-up visits
  2. * Participants undergoing unilateral mastectomy
  3. * Tissue expanders placed by a surgeon outside of the UNC Chapel Hill Hospital System
  4. * Undergoing autologous reconstruction
  5. * Participant is unable to provide signed and dated informed consent
  6. * Unwilling or unable to comply with all study-related procedures.
  7. * Known history of sensitivity or allergic reaction to any of the components of the Xperience™ irrigation solution or dilute povidone-iodine irrigation
  8. * Participant with any conditions that would be a contraindication to receiving surgery such as contraindications to general anesthesia
  9. * Pregnant, planning to become pregnant or breast feeding participants
  10. * 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.
  11. * Incarcerated participants

Contacts and Locations

Study Contact

Adeyemi Ogunleye, MD
CONTACT
(919) 966-4446
yemi@med.unc.edu
Alethia Burton
CONTACT
9198435547
alethia_burton@med.unc.edu

Principal Investigator

Adeyemi Ogunleye, MD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Adeyemi Ogunleye, MD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-30
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2025-06-30
Study Completion Date2028-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Surgical Site Infection
  • Surgical Complication
  • Implant Infection
  • Implant Complication