NCT06188819

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: University Paul Sabatier of Toulouse · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Infections and Inflammations

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-01-02
• Completion: 2024-06-15
• First posted: 2024-01-03
• Last updated: 2024-01-10