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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with abdominal aortic pathology | Patients with abdominal aortic pathology (aneurysmal or steno occlusive disease) candidate to open repair with PuraBond haemostatic agent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Purabond | Device | hemostatic efficacy of PuraBond |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Hemostasis | time that goes from declamping to closing the abdomen | during the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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The Study will include 100 patients with abdominal aortic pathology (aneurysmal or steno occlusive disease) candidate to open repair with PuraBond haemostatic agent in Vascular Surgery Unit, San Raffaele Hospital (Milan, Italy)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniele Mascia, MD | Contact | +390226437141 | 7141 | mascia.daniele@hsr.it |
| Elisa Simonini, DR | Contact | +390226437141 | 7141 | simonini.elisa@hsr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele Hospital | Recruiting | Milan | Italy | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23642926 | Background | Berger JS, Hochman J, Lobach I, Adelman MA, Riles TS, Rockman CB. Modifiable risk factor burden and the prevalence of peripheral artery disease in different vascular territories. J Vasc Surg. 2013 Sep;58(3):673-81.e1. doi: 10.1016/j.jvs.2013.01.053. Epub 2013 May 2. | |
| 14709362 | Background | Diehm C, Schuster A, Allenberg JR, Darius H, Haberl R, Lange S, Pittrow D, von Stritzky B, Tepohl G, Trampisch HJ. High prevalence of peripheral arterial disease and co-morbidity in 6880 primary care patients: cross-sectional study. Atherosclerosis. 2004 Jan;172(1):95-105. doi: 10.1016/s0021-9150(03)00204-1. |
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| 25151345 | Background | Shander A, Kaplan LJ, Harris MT, Gross I, Nagarsheth NP, Nemeth J, Ozawa S, Riley JB, Ashton M, Ferraris VA. Topical hemostatic therapy in surgery: bridging the knowledge and practice gap. J Am Coll Surg. 2014 Sep;219(3):570-9.e4. doi: 10.1016/j.jamcollsurg.2014.03.061. Epub 2014 Jun 2. No abstract available. |