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

Trial Summary

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 data supports the effectiveness of the treatment Xperience™ for preventing surgical site infections?

Research shows that using irrigation solutions with antibiotics or antiseptics during surgery can lower the chances of getting an infection at the surgical site. This suggests that treatments like Xperience™, which may involve similar irrigation methods, could be effective in preventing infections. ^{1 2 3 4 5}

How does the Xperience™ treatment for surgical site infections differ from other treatments?

Xperience™ irrigation is unique because it involves the use of pulsed lavage, a method that uses a pressurized stream of fluid to clean surgical sites, which is not commonly used outside of orthopedic surgery. This approach may help reduce surgical site infections by effectively removing debris and bacteria from the wound area. ^{1 2 3 4 6}

What is the purpose of this trial?

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.

Research Team

Adeyemi Ogunleye, MD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of Pulsed Lavage Reduces the Rate of Surgical Site Infection After Laparotomy. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Intra-Cavity Lavage and Wound Irrigation for Prevention of Surgical Site Infection: Systematic Review and Network Meta-Analysis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Intra-Operative Surgical Irrigation of the Surgical Incision: What Does the Future Hold-Saline, Antibiotic Agents, or Antiseptic Agents? [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Importance of wound irrigation solutions and fluids with antiseptic effects in therapy and prophylaxis : Update 2017]. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Novel antibiotic irrigation device versus standard O-ring wound retractor in the prevention of surgical site infection following colorectal resection. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Antibiotic irrigations. A plea for controlled clinical trials. [2019]