VASCular no-REact® Graft Against INfection (VASC-REGAIN) Trial

VASCular no-REact® Graft Against INfection (VASC-REGAIN) Trial - VASC-REGAIN trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49830

Enrollment

Registered

2017-05-09

Start date

2017-12-22

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vascular infection

Interventions

Included patients will have an operation for the implantation of the No-React® Non-Valved Conduit (NRVC) as vascular conduit.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Infected prosthetic graft and/or bifurcation, or high risk of infection at graft implantation, or mycotic aneurysm, and no safe alternative available

Exclusion criteria

Exclusion criteria: Below-knee bypass AV access

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is graft infection at 3 months after implantation. Related variables to be measured include: 1. Febrile or non-febrile status 2. WBC count 3. C-reactive protein (CRP) test 4. Samson classification of the infection (grade I-V) (for peripheral situations) I. Infections extend no deeper than the dermis II. Infections involve subcutaneous tissues but do not come into grossly observable contact with the graft III. Infections involve the body of the graft but not at an anastomosis IV. Infections surround an exposed anastomosis but bacteremia or anastomotic bleeding has not occurred V. Infections involve a graft-to-artery anastomosis and are associated with septicemia and/or bleeding at the time of presentation OR CT findings (for central situations) 5. Patient temperature 6. Wound healing 7. Wound infection 8. If debridement was performed 9. Purulence	—

Measure

Time frame

The primary endpoint of the study is graft infection at 3 months after implantation. Related variables to be measured include: 1. Febrile or non-febrile status 2. WBC count 3. C-reactive protein (CRP) test 4. Samson classification of the infection (grade I-V) (for peripheral situations) I. Infections extend no deeper than the dermis II. Infections involve subcutaneous tissues but do not come into grossly observable contact with the graft III. Infections involve the body of the graft but not at an anastomosis IV. Infections surround an exposed anastomosis but bacteremia or anastomotic bleeding has not occurred V. Infections involve a graft-to-artery anastomosis and are associated with septicemia and/or bleeding at the time of presentation OR CT findings (for central situations) 5. Patient temperature 6. Wound healing 7. Wound infection 8. If debridement was performed 9. Purulence

—

Secondary

Measure	Time frame
The second endpoint to be determined is patency at 12 months. Related variables to be measured include: 1. Clinical assessment at 3 and 12 months 2. Duplex ultrasound (for peripheral situations) or CTA (for central situations) at 3 and 12 months	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)