Outcomes of Natives and Graft-related Femoral Reconstruction With Tubulized Pericardial Patchs

Recruiting

• Conditions: Vascular Complications

• Registration Number: NCT05881954
• Lead Sponsor: University Paul Sabatier of Toulouse

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.

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 Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-01-10
• Study First Submitted: 2023-04-28
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-20
• Last Update Submitted: 2023-05-20
• Study First Posted: 2023-05-31
• Last Update Posted: 2023-05-31
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patency	3 months	Patency of the bypass
Absence of reinfection	After antibiotherapy (6 weeks generally)	Disparition of infections signs : biological and clinically

Secondary Outcome Measures

Name	Time	Method
Late patency	6 months	Patency of the Bypass
Reintervention	30 days post operative; 3 months, 6 months, 12 months	Need of reoperation during the follow up

Trial Locations

Locations (1)

Aurélien Hostalrich [ahostalrich]; 🇫🇷 Toulouse, France