Surgical Site InfectionNCT06649890
A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
A study testing Xperience™ Advanced Surgical Irrigation and Dilute Povidone-Iodine in people with Surgical Site Infection and Surgical Complication, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection, Surgical Complication, Implant Infection
- What is being tested?
- Xperience™ Advanced Surgical Irrigation and Dilute Povidone-Iodine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill Hospital
Chapel Hill, North Carolina, 27514
Adeyemi Ogunleye, MD, 919-966-4446, yemi@med.unc.edu
Alethia Burton, 9198435547, alethia_burton@med.unc.edu
About this study
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
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.
Read more
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.
- Being tested
- Xperience™ Advanced Surgical Irrigation, Dilute Povidone-Iodine
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xperience™ Advanced Surgical IrrigationDevice
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.
Dilute Povidone-IodineDevice
Also called Dilute Betadine
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.
| Study group | Role | What they receive |
|---|---|---|
| Xperience™ Advanced Surgical Irrigation | Experimental | Not described Receives: Device: Xperience™ Advanced Surgical Irrigation |
| Dilute Povidone-Iodine | Active comparator | Not described Receives: Device: Dilute Povidone-Iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Surgical Site Infections
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.
Measured: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.
Secondary outcomes (2)
Rate of Implant Explantation
Number of patients who required non-elective implant explantation.
Measured: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.
Rate of Non-Infectious Post-Surgical Complications
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
Measured: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start30 Jun 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeyemi Ogunleye, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649890
- Sponsor's protocol ID
- 24-0853
- Status last verified
- Jun 2025
- First submitted
- 14 May 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06649890
- Acronym / sponsor ID
- 24-0853
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xperience™ Advanced Surgical Irrigation | Experimental | Device: Xperience™ Advanced Surgical Irrigation |
| Dilute Povidone-Iodine | Active comparator | Device: Dilute Povidone-Iodine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xperience™ Advanced Surgical IrrigationXperience™ 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. | Device | Xperience™ Advanced Surgical Irrigation |
| Dilute Povidone-IodineAlso: Dilute Betadine5% 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. | Device | Dilute Povidone-Iodine |
Primary outcome
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.
2 secondary outcomes
Rate of Implant Explantation
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adeyemi Ogunleye, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xperience™ Advanced Surgical Irrigation and Dilute Povidone-Iodine in people with Surgical Site Infection and Surgical Complication, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adeyemi Ogunleye, MD ((919) 966-4446, yemi@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Surgical Site Infections (time frame: Within 90 days of implant/tissue expander placement, with the day of placement Day 0.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.