Vialize for Surgical Site Infections

Overseen By Bjoern Mueller

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Local antibiotics

Disqualifiers: Negative pressure therapy, Organ transplant, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day (surgery)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Vialize, which might reduce complications like infections after groin incisions in vascular surgeries. Many patients face problems after these surgeries, so the researchers aim to determine if Vialize can lower these rates. The trial seeks patients undergoing vascular procedures with groin incisions, such as treatments for diseases affecting blood flow or certain types of bypass surgery. As an unphased trial, it offers patients the chance to contribute to important research that could enhance surgical outcomes.

Do I need to stop my current medications for the trial?

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 Vialize is safe for use in vascular surgeries involving a groin incision?

Research shows that Vialize is a new treatment being tested in surgeries to prevent infections at the surgical site. Specific safety data from studies on Vialize is not yet available. Its "Not Applicable" phase indicates that Vialize is in the early stages of testing, and its safety might not be fully known.

Researchers closely monitor treatments in early testing for any side effects or problems. If Vialize had shown serious safety issues earlier, it likely would not have progressed in testing.

Vialize is made from human placental tissue. Similar products are sometimes used in medical settings, suggesting they can be safe, but each product may have different effects.

Prospective trial participants should ask the study team about any known side effects or safety concerns related to Vialize. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for surgical site infections, which typically involve antibiotics and antiseptic measures, Vialize offers a novel approach by using a lyophilized dehydrated complete human placental membrane allograft. This means that Vialize leverages biological materials that can potentially promote healing and reduce infections in a natural way. Researchers are excited about Vialize because it introduces a new mechanism of action by utilizing the unique properties of human placental tissue, which may enhance tissue regeneration and create a more favorable environment for wound healing compared to traditional methods.

What evidence suggests that Vialize is effective for surgical site infections?

Research shows that Vialize, a treatment derived from the outer layer of the placenta, may help reduce infections at surgical sites. Previous studies have found that similar treatments significantly lowered infection rates. For instance, by following certain procedures, infection rates dropped from 6.7% to 0.96%. This trial will specifically evaluate Vialize's effectiveness in preventing infections after groin surgeries related to blood vessels. By potentially reducing these infections, Vialize might also improve recovery and lower healthcare costs. ^{1 2 6 7 8}

Who Is on the Research Team?

Samir Shah, MD, MPH

Principal Investigator

COLLEGE-MEDICINE MD-SURGERY MD-SURGERY-VASCULAR

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are undergoing vascular surgeries involving groin incisions, such as treatments for peripheral arterial disease or aneurysm disease. It's not open to organ transplant recipients or those using certain wound therapies like negative pressure wound therapy.

Inclusion Criteria

I am being treated for conditions like blocked arteries in my legs, aneurysms, severe kidney disease, or I've had surgery related to these.

All subjects will be compensated

I am having a surgery involving an incision in my groin area.

Exclusion Criteria

Organ-transplant recipients will be excluded

I am not using wound therapy devices or local antibiotics like vancomycin powder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Vialize during vascular surgeries involving a groin incision

1 day (surgery)

1 visit (in-person)

Follow-up

Participants are monitored for surgical site infection and dehiscence

90 days

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Vialize

Trial Overview The study is testing the use of Vialize in patients with vascular diseases to see if it can reduce complications like infections and dehiscence (wound reopening) after surgery involving groin incisions.

How Is the Trial Designed?

Group I: Vialize Experimental Treatment 1 Intervention

Vialize is a lyophilized dehydrated complete human placental membrane allograft.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11655079/

Evaluating and Improving Surgical Site Infection Prevention Patient data. This table shows outcomes in terms of surgical site infection (SSI) rate, timely use of surgical antibiotic prophylaxis (SAP), ...

2. cdc.gov cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf

Surgical Site Infection Event (SSI) Based on the 2023 HAI data results published in the NHSN's HAI Progress Report, about a 2% increase in the SSI standardized infection ratio ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6823882/

Technological Advances in Clinical Definition and ... Automated detection of postoperative surgical site infections using supervised methods with electronic health record data. Stud Health Technol Inform 2015 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875021000917

Using a Data-Driven Improvement Methodology to ... After protocol implementation, the surgical site infection rate decreased from 6.7% (odds ratio, 2.82) to 0.96% (odds ratio, 0.91). The cost of implementation ...

5. journals.lww.com journals.lww.com/annalsofsurgery/fulltext/2025/09000/imaging_based_surgical_site_infection_detection.8.aspx

Imaging-based Surgical Site Infection Detection Using... For the purposes of this study, SSI outcomes were obtained from NSQIP and considered the gold standard as the data are independently and prospectively collected ...

6. cdc.gov cdc.gov/nhsn/pdfs/opc/opc-ssi-protocol-current-508.pdf

OPC SSI Surveillance The CDC healthcare-associated infection (HAI) prevalence survey found that there were an estimated 110,800 surgical site infections (SSIs) associated with ...

7. restoredcdc.org restoredcdc.org/www.cdc.gov/nhsn/faqs/faq-ssi.html

FAQs: Surgical Site Infections (SSI) Events | NHSN An SSI can only be a primary infection and must be reported if criteria are met. There may be additional primary infections present which may also be reportable ...

8. apic.org apic.org/Resource_/TinyMceFileManager/Academy/ASC_101_resources/Surveillance_NHSN/NHSN_9pscSSIcurrent_jan2015.pdf

Surgical Site Infection (SSI) Event Requirements: Perform surveillance for SSI following at least one NHSN operative procedure category (Table 1) as indicated in the Patient Safety ...