Xperience™ Irrigation for Surgical Site Infections

Overseen By Alethia Burton

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Unilateral mastectomy, Autologous reconstruction, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

224 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new surgical irrigation solution, Xperience™, reduces infections more effectively than the standard povidone-iodine solution in women undergoing implant-based breast reconstruction. The trial aims to determine if Xperience™ results in fewer infections and complications after surgery. Women undergoing a double mastectomy followed by implant reconstruction, who can attend follow-up visits, are suitable candidates for this trial. Researchers will randomly assign participants to receive either the new solution or the standard one, and they will closely monitor post-surgery outcomes. As an unphased trial, this study allows participants to contribute to important research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Xperience™ surgical irrigation solution is safe for use in breast reconstruction surgeries?

Research shows that Xperience™ Advanced Surgical Irrigation helps prevent infections after surgery by washing away debris and germs. This solution does not require rinsing and has been studied for its effectiveness in reducing infections. Although past studies provide limited safety data, the product's use in improving surgical clean-up generally suggests it is well-tolerated. The trial is in an early phase, so safety is still under evaluation. However, treatments at this stage are usually deemed safe enough for further testing. For any concerns, discussing them with the research team can provide more personalized information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Xperience™ Advanced Surgical Irrigation because it offers a novel approach to preventing surgical site infections. Unlike traditional methods, which often involve topical antiseptics like povidone-iodine, Xperience™ uses an advanced irrigation technique that may provide more thorough cleansing of the surgical area. This could potentially reduce the risk of infection more effectively and improve patient outcomes. By enhancing the removal of bacteria and debris during surgery, Xperience™ represents a promising step forward in infection control.

What evidence suggests that Xperience™ is effective for reducing surgical site infections?

Research has shown that Xperience™ surgical irrigation, which participants in this trial may receive, might help reduce infections after surgery. One study found no infections in the group using Xperience™, while the group not using it had a 0.49% infection rate. This suggests that Xperience™ could lower the risk of infections during surgery. Additionally, the overall complication rate with Xperience™ was 7.82%, but none of these complications were caused by the solution itself. These results indicate that Xperience™ could be a promising option for preventing infections in surgeries like breast reconstruction. Another treatment arm in this trial involves the use of Dilute Povidone-Iodine as an active comparator. ^{3 6 7 8 9}

Who Is on the Research Team?

Adeyemi Ogunleye, MD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older who are undergoing implant-based breast reconstruction post-mastectomy. Participants must be eligible for the surgery and not have conditions that could interfere with wound healing or infection assessments.

Inclusion Criteria

Willing to comply with all study-related procedures

Available for the duration of the study

I am having a double mastectomy with planned breast reconstruction.

Exclusion Criteria

Tissue expanders placed by a surgeon outside of the UNC Chapel Hill Hospital System

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Participants undergo the surgical procedure using either Xperience™ or dilute povidone-iodine solution

1 day

1 visit (in-person)

Post-operative Monitoring

Participants receive regular post-operative check-ups to monitor for signs of infection and other complications

12 weeks

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Xperience™

Trial Overview The study compares Xperience™, a novel surgical irrigation solution, to a standard dilute povidone-iodine solution in preventing infections after breast reconstruction surgery. Women will be randomly assigned to one of these treatments without knowing which one they receive.

How Is the Trial Designed?

Group I: Xperience™ Advanced Surgical Irrigation Experimental Treatment 1 Intervention

Group II: Dilute Povidone-Iodine Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11001957/

Real-World Evidence of the Impact of a Novel Surgical ... XPERIENCE is a promising intra-operative antimicrobial irrigant that can be easily incorporated into a broader infection prevention strategy.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38588520/

Real-World Evidence of the Impact of a Novel Surgical ... An overall complication rate of 7.82% was noted with none of the complications associated with usage of the novel surgical irrigant. Conclusions: XPERIENCE is a ...

3. journaloei.scholasticahq.com journaloei.scholasticahq.com/article/121295-the-use-of-a-novel-surgical-irrigant-may-be-associated-with-decreased-incidence-of-surgical-site-infections

Novel Surgical Irrigant May Decrease Infections The overall SSI rate was 0% (0/471) in the XP group and 0.49% (4/824) in the control group (P = 0.3). The overall return to OR rate was 0.21% (1 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05543941

Evaluating XPERIENCE™ Advanced Surgical Irrigation Most clinical studies have one primary outcome measure, but some have more than one. ... The main reason for the clinical trial. The types of primary purpose are: ...

5. sciqst.com sciqst.com/XPERIENCE%C2%AE%20Advanced%20Surgical%20Irrigation%20in%20Total%20Knee%20Arthroplasty:%20A%20Promising%20Tool%20for%20Reducing%20Infections

XPERIENCE® Advanced Surgical Irrigation in Total Knee ... Studies have shown that the use of this irrigation system can lead to a reduction in surgical site infections (SSI) and periprosthetic joint ...

6. zimmerbiomet.com zimmerbiomet.com/en/products-and-solutions/specialties/surgical/xperience-wound-lavage.html

XPERIENCE® Advanced Surgical Irrigation XPERIENCE no-rinse wound lavage is designed to help prevent surgical site infections by rinsing away debris and microorganisms.

7. novussurgical.com.au novussurgical.com.au/products/novus-surgical-solution

XPERIENCE® Advanced Surgical Irrigation XPERIENCE is a no rinse surgical solution, designed to help prevent surgical site infections by rinsing away debris and microorganisms.

8. ctv.veeva.com ctv.veeva.com/study/a-novel-surgical-irrigation-solution-in-post-mastectomy-reconstruction-evaluating-xperience

A Novel Surgical Irrigation Solution in Post-Mastectomy ... The purpose of this clinical trial is to learn whether Xperience™ surgical irrigation solution is more effective than a standard dilute povidone ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06649890

A Novel Surgical Irrigation Solution in Post-Mastectomy ... The purpose of this clinical trial is to learn whether Xperience™ surgical irrigation solution is more effective than a standard dilute povidone-iodine solution ...