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

U

University Paul Sabatier of Toulouse

Status

Active, not recruiting

Conditions

Aortic Infections and Inflammations

Treatments

Procedure: Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardium

Study type

Observational

Funder types

Other

Identifiers

NCT06188819
Infected Aorta

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

Cryopreserved arterial allograft
Description:
Aortic infection treated by cryopreserved arterial allograft
Treatment:
Procedure: Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardium
Rolled pericardium patch
Description:
Aortic infection treated by Pericardium patch rolled
Treatment:
Procedure: Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardium

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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