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

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.

Study Overview

• Status: Recruiting
• Conditions: Vascular Complications
• Intervention / Treatment: Procedure: Groin infection

Detailed Description

Groin wound infection after vascular surgery is a frequent complication with a significant increase in post operative morbidity and mortality. Actual studies reported more than 20% of patients who develop groin wound infection with an important rate of reintervention and risk in limb loss. Theses groin complications are frequent in drug abusers but can also happen after percutaneous femoral access for endovascular therapy leading to arterial reconstruction.

After mechanical debridement and eventually muscle flap rotation, ESVS 2020 guidelines recommend in situ reconstruction with the use of autogenous reconstruction vein femoral vein but it is a demanding surgery especially in redo surgery with extensive incision and deep venous complication. Saphenous vein is often too small in diameter to perform a femoro-femoral reconstruction. The other possibility is cryopreserved Cadaveric Arterial Allograft which are difficult to obtain in sufficient time for an urgent operation with frequent aneurysmal evolution. Literature reports up to 30% of reinfection with rifampin-soaked Dacron conduit are used with frequent reintervention. Rolled Bovine pericardium grafts have been proposed as a primary intention substitute in native and prosthetics aortic infections and are presented as resistant to infection when used as patch repair in case of groin complications. The aim of our study was to evaluate the outcomes in term of patency, limb salvage and infection resistance of this substitute when tubulized with stample in groin wound infection to replace previous prosthetic graft with active infection or false aneurysm rupture or after percutaneous septic femoral access complication in emergency surgery.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Aurélien H [ahostalrich]; Phone Number: 0673303969; Email: hostalrich.a@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • Aurélien Hostalrich [ahostalrich]
    • Contact: Aurélien H [ahostalrich]; Phone Number: 0673303969; Email: hostalrich.a@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients presenting a graft infection in the groin or a septic false aneurysm of the femoral artery.

Description

Inclusion Criteria:

• Previous femoral artery reconstruction with infected graft
• Femoral artery septic false aneurysm needed complete arterial reconstruction (drug abuser or percutaneous femoral access)

Exclusion Criteria:

• Simple patch closure of femoral artery
• Groin infection without femoral artery reconstruction Pregnancy Minors

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patency	Patency of the bypass	3 months
Absence of reinfection	Disparition of infections signs : biological and clinically	After antibiotherapy (6 weeks generally)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reintervention	Need of reoperation during the follow up	30 days post operative; 3 months, 6 months, 12 months
Late patency	Patency of the Bypass	6 months

Collaborators and Investigators

• Sponsor: University Paul Sabatier of Toulouse

Publications and helpful links

General Publications

• 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.
• McMillan 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): January 10, 2020
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: May 20, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 20, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: FEMORALROLLED