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This dual mechanism creates a stable clot that adheres to the wound site and is gradually absorbed as healing progresses.","oneSentence":"FloSeal is a hemostatic matrix that combines gelatin and thrombin to form a biologically active scaffold that promotes rapid clot formation and hemostasis at surgical bleeding sites.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:46:35.736Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemostasis during surgical procedures where bleeding control is needed"},{"name":"Adjunctive hemostatic agent in general, cardiac, and vascular surgery"}]},"trialDetails":[{"nctId":"NCT07232927","phase":"NA","title":"Evaluation of Hemostatic Agents in Partial Nephrectomy","status":"COMPLETED","sponsor":"Ankara University","startDate":"2023-01-02","conditions":"Partial Nephrectomy, Hemostatic Agents, Localized Renal Cell Carcinoma","enrollment":150},{"nctId":"NCT02488135","phase":"NA","title":"Management of Persistent Epistaxis Using Floseal Hemostatic Matrix","status":"COMPLETED","sponsor":"University of Alberta","startDate":"2015-07-01","conditions":"Epistaxis","enrollment":26},{"nctId":"NCT04310150","phase":"PHASE4","title":"Collagen-thrombin Matrix Efficacy During Cardiac Surgery: a Prospective Randomized Controlled Trial","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2018-02-05","conditions":"Coronary Artery Disease","enrollment":80},{"nctId":"NCT03328832","phase":"PHASE4","title":"Combined Topical Tranexamic Acid With Floseal® in Total Knee Arthroplasty","status":"COMPLETED","sponsor":"Chang Gung Memorial Hospital","startDate":"2017-09-12","conditions":"Osteoarthritis, Knee","enrollment":70},{"nctId":"NCT02638012","phase":"NA","title":"Prospective Pilot Study of Floseal for the Treatment of Anterior Epistaxis in Patients With (HHT)","status":"COMPLETED","sponsor":"Unity Health Toronto","startDate":"2015-12","conditions":"Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis","enrollment":8},{"nctId":"NCT03623789","phase":"PHASE4","title":"Blood-saving Effect of Combined Intravenous Tranexamic Acid With Topical Floseal® Application Total Hip Arthroplasty","status":"UNKNOWN","sponsor":"Chang Gung Memorial Hospital","startDate":"2018-08-15","conditions":"Hip Replacement, Total","enrollment":90},{"nctId":"NCT03725098","phase":"NA","title":"Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations","status":"COMPLETED","sponsor":"Biom'Up France SAS","startDate":"2019-03-01","conditions":"Cardiothoracic Surgery","enrollment":105},{"nctId":"NCT03528057","phase":"NA","title":"Evaluation of Hemostatic Agents in Robotic-assisted Laparoscopic Partial Nephrectomy","status":"WITHDRAWN","sponsor":"Northwestern University","startDate":"2018-04-18","conditions":"Robotic-Assisted Laparoscopic Partial Nephrectomy, Hemostatic Agents, Renal Malignant Tumor","enrollment":""},{"nctId":"NCT00990288","phase":"PHASE4","title":"The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery","status":"COMPLETED","sponsor":"Hospital for Special Surgery, New York","startDate":"2007-10","conditions":"Blood Loss","enrollment":196},{"nctId":"NCT01891461","phase":"PHASE4","title":"Study to Compare the Addition of Floseal to Our Standard of Care to Control Post Operative Bleeding in TKR","status":"COMPLETED","sponsor":"Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal","startDate":"2012-01","conditions":"Intraoperative Bleeding, Post-operative Bleeding","enrollment":132},{"nctId":"NCT02865174","phase":"PHASE4","title":"Topical Tranexamic Acid and Floseal® in Total Knee Arthroplasty","status":"UNKNOWN","sponsor":"Chang Gung Memorial Hospital","startDate":"2016-09","conditions":"Osteoarthritis, Knee","enrollment":90},{"nctId":"NCT01879475","phase":"NA","title":"Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery","status":"UNKNOWN","sponsor":"Medtrade","startDate":"2013-06","conditions":"C.Surgical Procedure; Cardiac, Haemorrhage.","enrollment":200},{"nctId":"NCT01857466","phase":"PHASE3","title":"Ovarian Reserve After Ovarian Hemostasis by Floseal Matrix","status":"COMPLETED","sponsor":"CHA University","startDate":"2012-12","conditions":"Ovarian Cysts","enrollment":100},{"nctId":"NCT01410240","phase":"PHASE4","title":"Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty","status":"COMPLETED","sponsor":"Baxter Healthcare Corporation","startDate":"2011-09","conditions":"Knee Replacement Surgery, Osteoarthritis","enrollment":137},{"nctId":"NCT00742313","phase":"PHASE4","title":"Effect on Bleeding When Using FloSeal Matrix™ in Subjects Undergoing Endoscopic Vein Harvest (EVH)","status":"TERMINATED","sponsor":"Duke University","startDate":"2009-06","conditions":"Bleeding","enrollment":50},{"nctId":"NCT01268930","phase":"NA","title":"Comparison of Hemostatic Matrix and Bipolar Coagulation in Surgical Treatment of Endometriomas","status":"COMPLETED","sponsor":"Ankara University","startDate":"2010-09","conditions":"Ovarian Reserve, Endometrioma","enrollment":30},{"nctId":"NCT01126281","phase":"PHASE4","title":"Efficacy and Safety of Floseal for the Haemostasis During Laparoscopic Cholecystectomy in Acute Cholecystitis (GLA)","status":"UNKNOWN","sponsor":"University of Bologna","startDate":"2010-08","conditions":"Cholecystitis, Acute","enrollment":120}],"_emaApprovals":[],"_faersSignals":[{"count":4,"reaction":"POST PROCEDURAL COMPLICATION"},{"count":2,"reaction":"STATUS EPILEPTICUS"},{"count":1,"reaction":"BLOOD BILIRUBIN INCREASED"},{"count":1,"reaction":"BLOOD PRESSURE DECREASED"},{"count":1,"reaction":"DEATH"},{"count":1,"reaction":"END-TIDAL CO2 DECREASED"},{"count":1,"reaction":"HYPOTENSION"},{"count":1,"reaction":"ILEUS PARALYTIC"},{"count":1,"reaction":"INTRACRANIAL PRESSURE INCREASED"},{"count":1,"reaction":"OXYGEN SATURATION DECREASED"}],"_approvalHistory":[],"publicationCount":25,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Floseal"],"phase":"marketed","status":"active","brandName":"Floseal hemostatic matrix","genericName":"Floseal hemostatic matrix","companyName":"Chang Gung Memorial Hospital","companyId":"chang-gung-memorial-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Floseal hemostatic matrix is used to control bleeding during laparoscopic cholecystectomy in acute cholecystitis and as a treatment for epistaxis. The exact mechanism of action of Floseal is unknown.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}