Outcomes of Natives and Graft-related Femoral Reconstruction With Tubulized Pericardial Patchs
Early Outcomes of Natives and Graft-related Femoral Reconstruction Managed With Orthotopic Xenopericardial Patchs
1 other identifier
observational
20
1 country
1
Brief Summary
Groin wound infection after arterial femoral prosthetic reconstruction or percutaneous access and drug abusers are frequent and increase largely the post operative morbi-mortality. There is no perfect substitute to replace infected graft or to restaure femoral artery in septic condition moreover when all the femoral bifurcation is involved with a femoro-femoral bypass mandatory. Seeing the encouraging results of rolled pericardium patch to treat native and prosthetics aortic infections in term of patency and infection resistance, the investigators propose to evaluate the outcomes of this subsitute rolled with samples in case of femoro-femoral repair in septic condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2020
CompletedFirst Submitted
Initial submission to the registry
April 28, 2023
CompletedFirst Posted
Study publicly available on registry
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedMay 31, 2023
May 1, 2023
9 days
April 28, 2023
May 20, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Patency
Patency of the bypass
3 months
Absence of reinfection
Disparition of infections signs : biological and clinically
After antibiotherapy (6 weeks generally)
Secondary Outcomes (2)
Reintervention
30 days post operative; 3 months, 6 months, 12 months
Late patency
6 months
Interventions
Femoral artery reconstruction with tubulized pericardium patch
Eligibility Criteria
Patients presenting a graft infection in the groin or a septic false aneurysm of the femoral artery.
You may qualify if:
- Previous femoral artery reconstruction with infected graft
- Femoral artery septic false aneurysm needed complete arterial reconstruction (drug abuser or percutaneous femoral access)
You may not qualify if:
- Simple patch closure of femoral artery
- Groin infection without femoral artery reconstruction Pregnancy Minors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aurélien Hostalrich [ahostalrich]
Toulouse, 31059, France
Related Publications (2)
Alonso W, Ozdemir B, Chassin-Trubert L, Ziza V, Alric P, Canaud L. Early outcomes of native and graft-related abdominal aortic infection managed with orthotopic xenopericardial grafts. J Vasc Surg. 2021 Jan;73(1):222-231. doi: 10.1016/j.jvs.2020.04.513. Epub 2020 May 20.
PMID: 32442610BACKGROUNDMcMillan WD, Leville CD, Hile CN. Bovine pericardial patch repair in infected fields. J Vasc Surg. 2012 Jun;55(6):1712-5. doi: 10.1016/j.jvs.2011.11.139. Epub 2012 Mar 28.
PMID: 22459752BACKGROUND
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Hostalrich Aurelien, MD, Clinical Professor
Study Record Dates
First Submitted
April 28, 2023
First Posted
May 31, 2023
Study Start
January 1, 2020
Primary Completion
January 10, 2020
Study Completion
September 1, 2023
Last Updated
May 31, 2023
Record last verified: 2023-05