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10.3389/fsurg.2015.00029 http://scihub22266oqcxt.onion/10.3389/fsurg.2015.00029 C4486749!4486749!26191528     free     free     free Deprecated: Implicit conversion from float 213.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Front+Surg 2015 ; 2 (ä): ä Nephropedia Template TP {{tp|p=26191528|t=2015. Results from a First-in-Human Trial of a Novel Vascular Sealant |pdf=|usr=}}{{26191528}} gab.com Text Results from a First-in-Human Trial of a Novel Vascular Sealant JO: Front Surg http://www.kidney.de/pget.php?&tw=1&pmid=26191528 #FOAvip Background: Suture hole bleeding from synthetic grafts presents a hemostatic challenge. The designs of many vascular sealants are not optimal (non-adherence to wet surfaces, excessive swelling, inflexible). PreveLeak? (formerly ArterX®) is a polyaldehyde?bovine serum albumin-based sealant whose efficacy, safety, and performance were evaluated in this first-in-human study. Materials and methods: A prospective, single-arm, multicenter study was performed in patients undergoing open vascular reconstructions with prosthetic grafts. Sealant was applied to the suture line after completion of the anastomosis. The primary endpoint was the incidence of immediate sealing (without clinically significant bleeding) upon clamp release. Secondary endpoints were time to sealing, safety, and assessment of product performance. Results: Fifty-six anastomoses were performed in 32 patients. Grafts were Dacron (66% of sites), polytetrafluoroethylene (PTFE; 32%), or both Dacron and PTFE (2%). The femoral artery was the most common site of anastomosis (41% of sites). Immediate sealing after clamp release was achieved at all anastomoses (100%); 93% had no bleeding and 7% had oozing. No rebleeding occurred during 10?min of observation. The three most common adverse events were graft or bypass occlusion (n?=?5 patients), infection (n?=?4), and seroma (n?=?3); none were device related. The sealant was considered easy to apply, quickly forming a soft gel, and adhering to tissue and grafts. Conclusion: PreveLeak effectively sealed anastomotic suture lines during vascular reconstruction procedures and was considered easy to use. Adverse events were consistent with those commonly observed in patients undergoing surgical procedures. These results provided the support for conducting a larger controlled clinical trial. Twit Text FOAVip Results from a First-in-Human Trial of a Novel Vascular Sealant ????Front Surg http://www.kidney.de/pget.php?&tw=1&pmid=26191528 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=26191528 #FOAvip English Wikipedia <ref>{{Cite pmid|26191528}}</ref> Results from a First-in-Human Trial of a Novel Vascular Sealant #MMPMID26191528 Florek HJ; Brunkwall J; Orend KH; Handley I; Pribble J; Dieck R Front Surg 2015[]; 2 (ä): ä PMID26191528show ga Background: Suture hole bleeding from synthetic grafts presents a hemostatic challenge. The designs of many vascular sealants are not optimal (non-adherence to wet surfaces, excessive swelling, inflexible). PreveLeak? (formerly ArterX®) is a polyaldehyde?bovine serum albumin-based sealant whose efficacy, safety, and performance were evaluated in this first-in-human study. Materials and methods: A prospective, single-arm, multicenter study was performed in patients undergoing open vascular reconstructions with prosthetic grafts. Sealant was applied to the suture line after completion of the anastomosis. The primary endpoint was the incidence of immediate sealing (without clinically significant bleeding) upon clamp release. Secondary endpoints were time to sealing, safety, and assessment of product performance. Results: Fifty-six anastomoses were performed in 32 patients. Grafts were Dacron (66% of sites), polytetrafluoroethylene (PTFE; 32%), or both Dacron and PTFE (2%). The femoral artery was the most common site of anastomosis (41% of sites). Immediate sealing after clamp release was achieved at all anastomoses (100%); 93% had no bleeding and 7% had oozing. No rebleeding occurred during 10?min of observation. The three most common adverse events were graft or bypass occlusion (n?=?5 patients), infection (n?=?4), and seroma (n?=?3); none were device related. The sealant was considered easy to apply, quickly forming a soft gel, and adhering to tissue and grafts. Conclusion: PreveLeak effectively sealed anastomotic suture lines during vascular reconstruction procedures and was considered easy to use. Adverse events were consistent with those commonly observed in patients undergoing surgical procedures. These results provided the support for conducting a larger controlled clinical trial. äResults from a First-in-Human Trial of a Novel Vascular Sealant (epmc).pdf DeepDyve Pubget Overpricing