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)

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Groin incisions in vascular surgery have complications in up to 30% of cases at 30 days, resulting in reductions in patient quality of life and increased costs. Prior attempts at reducing this complication rate have been largely unsuccessful. The purpose of this study is to determine the feasibility of routine Vialize use for vascular surgeries involving a groin incision and to determine the rates of surgical site infection/dehiscence in such patients receiving subcutaneous Vialize.

Research Team

Samir Shah, MD, MPH

Principal Investigator

COLLEGE-MEDICINE MD-SURGERY MD-SURGERY-VASCULAR

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+