An observational study in Aortic Infections and Inflammations, sponsored by University Paul Sabatier of Toulouse. Active, not recruiting. Per ClinicalTrials.gov, last updated 2024-01-10.
Sponsored by University Paul Sabatier of Toulouse · Observational
While surgery with anatomic reconstruction of prosthetic aortic infections and native infectious aortitis has become established over time, the ideal substitute is not clearly defined. The cryopreserved arterial allograft (AAC) recognized as resistant to infections not only presents availability problems making its use complicated, particularly in emergencies, with a certain number of long-term aneurysmal developments. The tubulized pericardium patch (PP), available in all cases, seems to give promising results in recent literature. The investigators propose a comparative study of these two substitutes in this indication.
We carried out a two-center observational study including retrospectively from January 2010 to July 2023 all patients operated on for aortic prosthesis infection and native infectious aortitis with AAC reconstruction and prospectively PP patch reconstructions from July 2018 to July 2023. The diagnosis of infection was established according to the MAGIC criteria. The patients' preoperative comorbidities were collected to compare the groups. Postoperative morbidity and mortality was then compared. The medium-term evaluation consisted of comparing according to the Kaplan Meier method: postoperative mortality, permeability, reinfection rate, reoperation rate.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's enrollment of 150 is above the median of 100 across 864 observational studies indexed under Inflammation.
Browse Inflammation studies →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 operated on for a native infection or an aortic prosthesis who had pericardium or allograft reconstruction
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Exclusion Criteria:
Aortic infection treated by cryopreserved arterial allograft
Procedure: Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardium
Aortic infection treated by Pericardium patch rolled
Procedure: Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardium
In situ reconstruction with explantation of the infected graft or endograft and reconstruction by allograft or pericardium
Mortality
Number of patients death during post operative stay
Time frame: day 30 post operative
Reintervention
Rate of reintervention during post operative stay
Time frame: 30 days, 6 months, 12 months, 24 months
Post operative Major cardiovascular adverse events (MACE)
Rate of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
Time frame: day 30 post operative
Permeability
Rate of reintervention for occlusion of the patch or the allograft
Time frame: 30 days, 6 months, 12 months, 24 months
Reinfection
Rate of reintervention for infection of the patch or the allograft
Time frame: 30 days, 6 months, 12 months, 24 months
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This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University Paul Sabatier of Toulouse