An observational study in Vascular Complications, sponsored by University Paul Sabatier of Toulouse. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-31.
Sponsored by University Paul Sabatier of Toulouse · Observational
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.
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.
University Paul Sabatier of Toulouse is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
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Patients presenting a graft infection in the groin or a septic false aneurysm of the femoral artery.
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Exclusion Criteria:
Femoral artery reconstruction with tubulized pericardium patch
Patency
Patency of the bypass
Time frame: 3 months
Absence of reinfection
Disparition of infections signs : biological and clinically
Time frame: After antibiotherapy (6 weeks generally)
Reintervention
Need of reoperation during the follow up
Time frame: 30 days post operative; 3 months, 6 months, 12 months
Late patency
Patency of the Bypass
Time frame: 6 months
Ran from Jan 2020 to primary completion in Jan 2020, 0 months.
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This study is status unknown, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University Paul Sabatier of Toulouse