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

NCT06032949 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-08

No results posted yet for this study

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. 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

Interventions

OTHER

Vialize

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.

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Samir Shah, MD, MPH · COLLEGE-MEDICINE MD-SURGERY MD-SURGERY-VASCULAR

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-23
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06032949 on ClinicalTrials.gov