Clinical Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair

"A Physician-initiated, Observational, Prospective, Monocentric Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair "- PuraBond Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05733585

Enrollment

100

Registered

2023-02-17

Start date

2023-02-15

Completion date

2027-10-31

Last updated

2026-03-27

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

Conditions

Hemostatic

Brief summary

Purabond Study is a physician-initiated, observational, monocentric prospective Trial. The aim of the study is to investigate the hemostatic efficacy of PuraBond for aortic anastomoses and suture lines in patients with abdominal aortic pathology (aneurysmal or steno occlusive disease) candidate to open repair at Vascular Surgery Departement - San Raffaele Hospital (Milan, Italy). The Study will include 100 patients.

Interventions

DEVICEPurabond

hemostatic efficacy of PuraBond

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with ≥ 18 years of age, presenting with an abdominal aortic aneurysm (pararenal, juxtarenal, infrarenal, aorto-iliac mono/bilateral) * Use of the Purabond hemostatic agent in patients who, in the opinion of the Physician, don't have a satisfactory surgical haemostasis * Patients ≥ 18 years of age with steno-occlusive abdominal aortic or iliac disease * Patients that will treated by open repair , encompassing elective, urgent and emergency presentation, hospitalized and enrolled in Vascular Surgery Unit, San Raffaele Hospital (Milan, Italy) * Patients able to sign specific informed consent for the study

Exclusion criteria

* Patients whom exhibited preoperative derangements in haematological and coagulation profiles, and baseline derangements in liver function * Patients with abdominal aortic and/or iliac arteries disease candidate for endovascular treatment * Pregnant, breastfeeding, or planning on becoming pregnant within 24 months * Systemic infection (for example: sepsis) * Impossibility or refusal to give informed consent

Design outcomes

Primary

Measure	Time frame	Description
Time to Hemostasis	during the surgery	time that goes from declamping to closing the abdomen

Countries

Italy

Contacts

CONTACTDaniele Mascia, MD

mascia.daniele@hsr.it+390226437141

CONTACTElisa Simonini, DR

simonini.elisa@hsr.it+390226437141

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026