Clinical trial NCT05881954: Outcomes of Natives and Graft-related Femoral Reconstruction With Tubulized Pericardial Patchs
Official title: Early Outcomes of Natives and Graft-related Femoral Reconstruction Managed With Orthotopic Xenopericardial Patchs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vascular Complications
Lead sponsor: University Paul Sabatier of Toulouse
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting a graft infection in the groin or a septic false aneurysm of the femoral artery.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patency
timeFrame: 3 months
measure: Absence of reinfection
timeFrame: After antibiotherapy (6 weeks generally)
Secondary outcomes:
measure: Reintervention
timeFrame: 30 days post operative; 3 months, 6 months, 12 months
measure: Late patency
timeFrame: 6 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Aurélien Hostalrich [ahostalrich]
Study officials:
References:
citation: 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.
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.