A tissue sealant based on reactive multifunctional polyethylene glycol

Wallace, Donald G.; Cruise, Gregory M.; Rhee, Woonza; Schroeder, J. A.; Prior, J. J.; Ju, Jia; Maroney, Marcee; Duronio, J.; Ngo, Min-Van; Estridge, Trudy D.; Coker, G. C.

doi:10.1002/jbm.1053

Cited by 171 publications

(131 citation statements)

References 18 publications

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“…The NHS esters of NHS-PEG readily bind the ε-amino group of lysine residues and the N-terminal α-amino group of proteins [26]. PEG hydrogel sealants have previously been observed to have good adherence to biological tissue and to be effective in vivo [27].…”

Section: Discussionmentioning

confidence: 99%

Treatment of Severe Aortic Bleeding Using Hemopatch in Swine on Dual Antiplatelet Therapy

Baumgartner

Draxler

Lewis

2016

Journal of Investigative Surgery

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Purpose: The perioperative management of patients on antithrombotic therapy is currently an unresolved problem as these therapies pose a considerable risk for perioperative hemorrhagic complications. The presented studies investigated the efficacy of a new collagen technology to achieve hemostasis. A polyethylene glycol-coated collagen pad (PCC) was compared to a marketed fibrinogen-thrombin coated collagen pad (FTC) for the treatment of an aortotomy incision in heparinized swine on dual antiplatelet therapy. Materials and Methods: Twenty-eight 3-mm aortotomy incisions were created in nine heparinized pigs without antiplatelet therapy and treated with PCC. Sixty-eight aortotomy incisions were created in ten heparinized pigs that received clopidogrel (10-11 mg/kg) and acetylsalicylic acid (8-11 mg/kg) orally for 5 days, and treated with either PCC or FTC (N = 34/group). Dual antiplatelet therapy resulted in significantly reduced platelet function. Aortotomy incisions resulted in lifethreatening bleeding of 35-292 ml/min. Results: In animals without antiplatelet treatment, PCC provided 96% immediate hemostatic success. In animals with antiplatelet treatment, FTC provided 18% immediate hemostatic success increasing to 74% after 10 min. Strikingly, PCC provided 94% immediate success increasing to 100% after 10 min. Controlling for differences in pretreatment bleeding rates, statistical model-estimated time to hemostasis was 12 times shorter in PCC-treated lesions (p < .02). Conclusion: The combination of a procoagulant collagen pad with a synthetic sealing component provides excellent hemostatic properties under a worst-case scenario. PCC rapidly and firmly adheres to tissue, thereby controlling severe arterial bleeding, even when platelet function is significantly reduced. Treatment with PCC provided superior time to hemostasis compared to FTC.

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Section: Discussionmentioning

confidence: 99%

Treatment of Severe Aortic Bleeding Using Hemopatch in Swine on Dual Antiplatelet Therapy

Baumgartner

Draxler

Lewis

2016

Journal of Investigative Surgery

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“…These include fibrin glues, 1,2 collagen sheets with fibrin glues, 3 fibrillar collagen, 4 collagen with citric acid derivative, 5 gelatin with resorcin and formalin (GRF glue TM ), 6 albumin with glutaraldehyde, 7 cyanoacrylate, 8 and synthetic polymers. [9][10][11][12] However, these materials have a number of disadvantages and need to be improved for clinical use. Fibrin-based glues have been widely used in a variety of surgical procedures and are designed to mimic the physiology of the final steps of the blood coagulation cascade.…”

Section: Introductionmentioning

confidence: 99%

“…On the other hand, synthetic polymer-based glues have beeneasily syn-thesized with a molecular design that controls their absorbability, biodegradability, and reactivity, thus making them promising biomaterials. They are polymerized by using photoreactive 9,10 or reactive 11,12 monomers. However, photoactivation makes application of the glue quite difficult and nearly impossible in case of a hemorrhage.…”

Section: Introductionmentioning

confidence: 99%

A novel synthetic tissue‐adhesive hydrogel using a crosslinkable polymeric micelle

Murakami

Yokoyama

Okano

et al. 2006

J Biomedical Materials Res

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We prepared a novel tissue-adhesive hydrogel by using a polymeric micelle consisting of an aldehyde-terminated poly(ethylene glycol)-poly(D,L-lactide) (PEG-PLA) block polymer. A Schiff base is chemically formed between the amino groups in a polyallylamine and the aldehyde groups on the surface of polymeric micelles. The hydrogel was formed in approximately 2 s when the polymeric micelle solution and polyallylamine solution are mixed in vitro. The hydrogel was rapidly formed in vivo, and it adhered to a tissue surface. Our novel tissue-adhesive hydrogel creates no risk of infectious contaminations, because it consists of only synthetic materials. Further, PEG and PLA are known to be biocompatible and noncytotoxic. The results obtained in the present study show that a hydrogel prepared by the formation of a Schiff base between aldehyde and amine groups will potentially address the need for novel tissue-adhesive materials.

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“…4,11 A secure seal is maintained through a covalent tissue bond, even under high pressure in vessels such as the aorta. 12 Because CoSeal swells up to 4 times its volume within 24 hours, the surgeon should be mindful, when using it in a confined space, of its possible effect on surrounding structures. The gel is completely resorbed within 30 days.…”

Section: Discussionmentioning

confidence: 99%

Intraoperative Surgical Sealant Application during Cardiac Defect Repair

Garcia-Morales

Ramchandani

Loebe

et al. 2014

Texas Heart Institute Journal

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B leeding is a major sequela of cardiac surgery and is a significant cause of morbidity and death.1,2 Hemostasis can be challenging during complex cardiac surgery, particularly because of friable tissue, coagulopathy, poor visualization of the surgical field, and poor bleeding-site accessibility. Failure to achieve and maintain hemostasis and reinforce fragile tissue can result in additional bleeding, which can further reduce visibility in the operative field, increase blood loss, lengthen surgery, increase the use of blood products, and contribute to postoperative complications and reoperation. In addition to meticulous surgical technique, conventional sutures, and ligature clips, we now have a variety of therapeutic agents available to assist in hemostasis. When ligation or other conventional methods are ineffective or impractical, surgical sealants are used to prevent suture-line bleeding. During cardiac surgery, when surgeons often deal with cardiac chambers and arterial vessels that are under pressure, proper suture-line sealing is important to minimize bleeding and achieve superior clinical outcomes.We here present 2 reports on the use of CoSeal ® surgical sealant (Baxter Healthcare Corporation; Deerfield, Ill) for intraoperative bleeding during cardiac rupture repair. CoSeal, which contains a fibrin component of bovine origin, was developed as a hemostatic agent for use in cardiovascular anastomosis and is the combination of 2 synthetic polyethylene glycols, a hydrogen chloride solution, and a sodium phosphate/ sodium carbonate solution that cross-links with collagen as well as with other innate proteins adherent to the applied tissue. [4][5][6] Our studies were performed in compliance with human studies and U.S. Food and Drug Administration guidelines, and we obtained written consent from the patients after explaining the nature of the procedure. Case ReportsPatient 1: Contained Rupture of Left Ventricle. A 51-year-old woman with a family history of early coronary artery disease and a history of smoking and drug use experienced left-sided chest pain for 10 days before seeking medical attention. On admittance to a coronary care unit at a peripheral hospital, she was diagnosed with significant ischemic cardiomyopathy and acute myocardial infarction. Echocardiography revealed severe ventricular dysfunction and a left ventricular (LV) ejection fraction of <0.20. She underwent cardiac catheterization and placement of an intracoronary stent. During that procedure, occlusion of the mid left anterior descending coronary artery was observed. She continued to develop worsening heart failure symptoms with significant systolic ventricular impairment and severe mitral regurgitation.When admitted to our facility, the patient had pulmonary edema and was dependent upon inotropic agents. She was considered a candidate for placement of an LV

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A tissue sealant based on reactive multifunctional polyethylene glycol

Cited by 171 publications

References 18 publications

Treatment of Severe Aortic Bleeding Using Hemopatch in Swine on Dual Antiplatelet Therapy

Treatment of Severe Aortic Bleeding Using Hemopatch in Swine on Dual Antiplatelet Therapy

A novel synthetic tissue‐adhesive hydrogel using a crosslinkable polymeric micelle

Intraoperative Surgical Sealant Application during Cardiac Defect Repair

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