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Vialize for Surgical Site Infections

N/A

Recruiting

Led By Samir Shah, MD, MPH

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing vascular procedures with groin incisions

Patients must be at least 18 years old and able to complete baseline measurements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90-day post-op follow-up

Awards & highlights

Study Summary

This trial will study if using Vialize can reduce infection/dehiscence rates in patients who have groin incisions in vascular surgery, improving patient quality of life and reducing costs.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

The potential side effects of Vialize are not specified here, but generally could include local reactions at the site of application, possible allergic responses, or interference with wound healing processes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am 18 or older and can complete initial health assessments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90-day post-op follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90-day post-op follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90-day post-op follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The rate of infection at 90-day post-op follow-up in patients receiving Vialize during vascular surgeries involving a groin incision.

Secondary outcome measures

Readmission or prolongation of the index admission for groin infection

The patient quality of life (EQ-5D)

return to OR for groin infection

Trial Design

1Treatment groups

Experimental Treatment

Group I: VializeExperimental Treatment1 Intervention

Vialize is a lyophilized dehydrated complete human placental membrane allograft.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,636 Total Patients Enrolled

Samir Shah, MD, MPHPrincipal InvestigatorCOLLEGE-MEDICINE MD-SURGERY MD-SURGERY-VASCULAR

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment currently looking for new participants?

"Confirmed, this clinical trial is actively seeking out candidates. According to the information posted on clinicaltrials.gov, it was first listed on October 23rd 2023 and recently updated as of that same date."

Answered by AI

How many test subjects are currently participating in this clinical trial?

"Affirmative. Data from clinicaltrials.gov attests that this medical trial, which was first released on October 23rd 2023, is currently looking for participants. Approximately 60 individuals must be sourced from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vialize Use for the Reduction of Vascular Groin Incisional Dehiscence and Infection

2023. "Vialize Use for the Reduction of Vascular Groin Incisional Dehiscence and Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06032949.