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

August 6, 2025 updated by: University of North Carolina, Chapel Hill

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
224

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Adeyemi Ogunleye, MD
  • Phone Number: (919) 966-4446
  • Email: yemi@med.unc.edu

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina at Chapel Hill Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Grace A Longfellow, BS
        • Sub-Investigator:
          • Christina Kapsalis, MD

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Xperience™ Advanced Surgical Irrigation
Device: Xperience™ Advanced Surgical Irrigation
Xperience™ solution will be applied twice during reconstruction procedures: first after achieving hemostasis and second just before implant introduction. The solution will be warmed to body temperature before use. Both tissue expanders/implants and mastectomy pockets will be soaked with Xperience™, using sterile syringes. A 1-minute dwell time with a total volume of 500 mL per mastectomy pocket will be employed, twice. Additionally, 500 mL of Xperience™ will be applied to implants before insertion, with a 5-minute dwell time. Excess solution will be suctioned throughout, and no rinsing will occur post-irrigation. Surgical site closure will follow standard procedures.
Active Comparator: Dilute Povidone-Iodine
Device: Dilute Povidone-Iodine
5% dilute povidone-iodine solution will be prepared by mixing povidone-iodine solution and normal saline at the appropriate ratio. Both tissue expanders/implants and mastectomy pockets will be soaked with dilute povidone-iodine, using sterile syringes. A 1-minute dwell time with a total volume of 500 mL per mastectomy pocket will be employed, twice. Additionally, 500 mL of dilute povidone-iodine will be applied to implants before insertion, with a 5-minute dwell time. Excess solution will be suctioned throughout. Surgeon discretion will determine rinsing after irrigation. Surgical site closure will follow standard procedures.
Other Names:
  • Dilute Betadine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Surgical Site Infections
Time Frame: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.
Number of patients diagnosed with surgical site infections as per the diagnostic criteria outlined by the Centers for Disease Control National Healthcare Safety Network's 2024 Breast Surgery (BRST) Surgical Site Infection Criteria.
Within 90 days of implant/tissue expander placement, with the day of placement Day 0.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of Implant Explantation
Time Frame: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.
Number of patients who required non-elective implant explantation.
Within 90 days of implant/tissue expander placement, with the day of placement Day 0.
Rate of Non-Infectious Post-Surgical Complications
Time Frame: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.

Number of patients who experience the the following, but not limited to, post-surgical complications:

  • Delayed wound healing (superficial incisional dehiscence requiring serial dressing changes, office debridement and/or operative revision)
  • Hematoma
  • Seroma
  • Tissue expander leak/rupture
  • Tissue expander/Implant exposure/extrusion
Within 90 days of implant/tissue expander placement, with the day of placement Day 0.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adeyemi Ogunleye, MD, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-0853

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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