Vascular DiseasesNCT06032949
Vialize Use for the Reduction of Vascular Groin Incisional Dehiscence and Infection
A study testing Vialize in people with Vascular Diseases, run by University of Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Vialize
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study population will consist of patients undergoing vascular procedures with groin incisions. Patients must be at least 18- years-old and able to complete baseline measurements. All subjects will be compensated. Patients undergoing treatment for peripheral arterial disease (e.g., femoropopliteal bypass), aneurysm disease (e.g., aortofemoral bypass), end-stage kidney disease (e.g., loop thigh graft), and miscellaneous procedures (e.g., femoral exposure for delivery of device) will be eligible.
Who cannot join
- Patients undergoing use of negative pressure wound therapy (e.g., Prevena) and local antibiotic placement (e.g., vancomycin powder) will be excluded. Additionally, organ-transplant recipients will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health Heart & Vascular Hospital
Gainesville, Florida, 32608
About this study
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.
- Conditions
- Vascular Diseases
- Being tested
- Vialize
- Keywords
- groin infections, quality of life, readmission, groin incisions
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VializeOther
Any patients undergoing surgeries involving a groin incision (e.g., femoropopliteal bypass, aortofemoral bypass, loop thigh graft, femoral exposure for delivery of device) will receive Vialize subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Vialize | Other | Vialize is a lyophilized dehydrated complete human placental membrane allograft. Receives: Other: Vialize |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of infection at 90-day post-op follow-up in patients receiving Vialize during vascular surgeries involving a groin incision.
Aim 1
Measured: 90-day post-op follow-up
Secondary outcomes (3)
The patient quality of life (EQ-5D)
Measured: 90-day post-op follow-up
return to OR for groin infection
Measured: 90-day post-op follow-up
Readmission or prolongation of the index admission for groin infection
Measured: 90-day post-op follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start23 Oct 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients from 2 populations will be included: high-risk patients (any of the following: redo groin incision, active smoker, A1c \>/= 9.0, BMI \>/= 30) and non-high-risk patients.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir Shah, MD, MPH, Principal investigator, COLLEGE-MEDICINE MD-SURGERY MD-SURGERY-VASCULAR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032949
- Sponsor's protocol ID
- IRB202301216
- Status last verified
- Apr 2025
- First submitted
- 5 Sep 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vialize Use for the Reduction of Vascular Groin Incisional Dehiscence and Infection
- ClinicalTrials.gov ID
- NCT06032949
- Acronym / sponsor ID
- IRB202301216
- Conditions
- Vascular Diseases
- Keywords
- groin infections, quality of life, readmission, groin incisions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients from 2 populations will be included: high-risk patients (any of the following: redo groin incision, active smoker, A1c >/= 9.0, BMI >/= 30) and non-high-risk patients.
| Arm | Type | Receives |
|---|---|---|
| Vialize | Other | Other: VializeVialize is a lyophilized dehydrated complete human placental membrane allograft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The study population will consist of patients undergoing vascular procedures with groin incisions. Patients must be at least 18- years-old and able to complete baseline measurements. All subjects will be compensated. Patients undergoing treatment for peripheral arterial disease (e.g., femoropopliteal bypass), aneurysm disease (e.g., aortofemoral bypass), end-stage kidney disease (e.g., loop thigh graft), and miscellaneous procedures (e.g., femoral exposure for delivery of device) will be eligible.
Key exclusion criteria (1 listed)
- Patients undergoing use of negative pressure wound therapy (e.g., Prevena) and local antibiotic placement (e.g., vancomycin powder) will be excluded. Additionally, organ-transplant recipients will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VializeAny patients undergoing surgeries involving a groin incision (e.g., femoropopliteal bypass, aortofemoral bypass, loop thigh graft, femoral exposure for delivery of device) will receive Vialize subcutaneously. | Other | Vialize |
Primary outcome
The rate of infection at 90-day post-op follow-up in patients receiving Vialize during vascular surgeries involving a groin incision.
Time frame: 90-day post-op follow-up
Aim 1
3 secondary outcomes
The patient quality of life (EQ-5D)
Time frame: 90-day post-op follow-up
return to OR for groin infection
Time frame: 90-day post-op follow-up
Readmission or prolongation of the index admission for groin infection
Time frame: 90-day post-op follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Shah, MD, MPH principal investigator
COLLEGE-MEDICINE MD-SURGERY MD-SURGERY-VASCULAR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vialize in people with Vascular Diseases, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of infection at 90-day post-op follow-up in patients receiving Vialize during vascular surgeries involving a groin incision. (time frame: 90-day post-op follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.