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

Vascular Complications Clinical Trial

Official title:

Early Outcomes of Natives and Graft-related Femoral Reconstruction Managed With Orthotopic Xenopericardial Patchs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05881954
• Other study ID #: FEMORALROLLED
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: May 2023
• Source: University Paul Sabatier of Toulouse
• Contact: Aurélien H [ahostalrich]
• Phone: 0673303969
• Email: hostalrich.a[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2023
• Est. primary completion date: January 10, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vascular Complications

Intervention

Procedure:
• Groin infection
Femoral artery reconstruction with tubulized pericardium patch

Locations

Country	Name	City	State
France	Aurélien Hostalrich [ahostalrich]	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Paul Sabatier of Toulouse

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency	Patency of the bypass	3 months
Primary	Absence of reinfection	Disparition of infections signs : biological and clinically	After antibiotherapy (6 weeks generally)
Secondary	Reintervention	Need of reoperation during the follow up	30 days post operative; 3 months, 6 months, 12 months
Secondary	Late patency	Patency of the Bypass	6 months