Rolled Pericardium Versus Cryopreserved Allograft to Treat Native or Prosthetic Aortic Infection

Active, not recruiting

• Conditions: Aortic Infections and Inflammations

• Registration Number: NCT06188819
• Lead Sponsor: University Paul Sabatier of Toulouse

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2010-01-02
• Study First Submitted: 2023-12-18
• Study First Submitted QC: 2023-12-18
• Status Verified: 2024-01
• Study First Posted: 2024-01-03
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10
• Study Completion: 2024-06-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• All aortic intervention performed for native aortic infection reconstruction with patch or allograft
• All aortic intervention performed for infected graft reconstruction with patch or allograft

Exclusion Criteria

• no

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reintervention	30 days, 6 months, 12 months, 24 months	Rate of reintervention during post operative stay
Post operative Major cardiovascular adverse events (MACE)	day 30 post operative	Rate of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
Mortality	day 30 post operative	Number of patients death during post operative stay

Secondary Outcome Measures

Name	Time	Method
Reinfection	30 days, 6 months, 12 months, 24 months	Rate of reintervention for infection of the patch or the allograft
Permeability	30 days, 6 months, 12 months, 24 months	Rate of reintervention for occlusion of the patch or the allograft