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The Evicel Post-Authorization Surveillance Study

2014-08-27 03:12:23 | BioPortfolio

Summary

The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Peripheral Vascular Disease

Intervention

Fibrin Sealant (Human)

Location

Memorial Hospital
Jacksonville
Florida
United States
32216

Status

Recruiting

Source

Ethicon, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:23-0400

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Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures

A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures.

Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis

The purpose of this study is to evaluate the safety and hemostasis effectiveness of human plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery.

Clinical Trial for Fibrin Sealant in Knee Surgery

- Thermogenesis is a company that sells a machine for the production of fibrin sealant of single donor plasma, the CryoSeal Fibrin Sealant System (CS-1). - Fibrin sealant consist...

Fibrin Sealant in Esophageal Surgery

Anastomotic leakage remains a major complication after esophageal surgery. Amongst other preventive measures, fibrin sealant is a promising adjunct to conventional anastomotic techniques. ...

The Fibrin Pad CV Phase III Study

The objective of this study is to evaluate the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.

PubMed Articles [28736 Associated PubMed Articles listed on BioPortfolio]

Is human fibrin sealant a possible choice for the fixation of laparoscopic inguinal hernia repair? A single center experience and the analysis of the results after 326 TAPP in two years.

Groin hernioplasty is most intervention performed in the worldwide. The present study aimed to evaluate a combination between ultralight mesh and fibrin human sealant in the laparoscopic treatment of ...

Closure of a Post-Transplant Bronchial Dehiscence with Endobronchial Fibrin Sealant.

Airway complications following lung transplantation are well described and can lead to significant morbidity and mortality. Treatment options for anastomotic dehiscence include expectant management, p...

Aerosolized Fibrin Sealant Is Effective for Postoperative Edema and Ecchymosis in Open Rhinoplasty Without Osteotomy.

Fibrin sealant (FS) was approved as a hemostatic agent, sealant, and adhesive by the Food and Drug Administration in 1998. Our study sought to determine whether FS also reduced edema and pain in rhino...

Evaluation of a Novel Fibrin Sealant Patch in Hemorrhage Control After Vascular or Hepatic Injury.

Acute hemorrhage remains the leading cause of death in potentially survivable injuries. The use of topical hemostatic agents has increased over the last two decades with the evolution of damage contro...

Efficacy of a fibrin sealant (Tissucol Duo®) for the prevention of lymphocele after laparoscopic pelvic lymphadenectomy: a randomised controlled trial.

To assess the efficacy of Tissucol Duo® (Baxter AG) fibrin sealant in decreasing the incidence of lymphocele (LC) after pelvic laparoscopic lymph node dissection using harmonic shears.

Medical and Biotech [MESH] Definitions

An ergot derivative that has been used as a cerebral vasodilator and in peripheral vascular disease. It has been suggested to ameliorate cognitive deficits in cerebrovascular disease.

Flunarizine is a selective calcium entry blocker with calmodulin binding properties and histamine H1 blocking activity. It is effective in the prophylaxis of migraine, occlusive peripheral vascular disease, vertigo of central and peripheral origin, and as an adjuvant in the therapy of epilepsy.

A beta-adrenergic agonist that causes direct relaxation of uterine and vascular smooth muscle. Its vasodilating actions are greater on the arteries supplying skeletal muscle than on those supplying skin. It is used in the treatment of peripheral vascular disease and in premature labor.

A nonselective alpha-adrenergic antagonist. It is used in the treatment of hypertension and hypertensive emergencies, pheochromocytoma, vasospasm of RAYNAUD DISEASE and frostbite, clonidine withdrawal syndrome, impotence, and peripheral vascular disease.

A peripheral vasodilator that was formerly used in the management of peripheral and cerebral vascular disorders. It is hepatotoxic and fatalities have occurred. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1312)

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