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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06188819
Enrollment
150
Registered
2024-01-03
Start date
2010-01-01
Completion date
2024-06-15
Last updated
2024-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Infections and Inflammations

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.

Interventions

PROCEDUREExplantation 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

Sponsors

LUCAS BATISTELLA, MD
CollaboratorUNKNOWN
Kheira hireche, MD
CollaboratorUNKNOWN
Ludovic CANAUD, MD PhD
CollaboratorUNKNOWN
University Paul Sabatier of Toulouse
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mortalityday 30 post operativeNumber of patients death during post operative stay
Reintervention30 days, 6 months, 12 months, 24 monthsRate of reintervention during post operative stay
Post operative Major cardiovascular adverse events (MACE)day 30 post operativeRate of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

Secondary

MeasureTime frameDescription
Permeability30 days, 6 months, 12 months, 24 monthsRate of reintervention for occlusion of the patch or the allograft
Reinfection30 days, 6 months, 12 months, 24 monthsRate of reintervention for infection of the patch or the allograft

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026