{"id":"bioseal-fibrin-sealant","safety":{"commonSideEffects":[{"rate":null,"effect":"Infection at surgical site"},{"rate":null,"effect":"Seroma formation"},{"rate":null,"effect":"Allergic reaction"},{"rate":null,"effect":"Thromboembolism (rare)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The product combines human fibrinogen and human thrombin to create a fibrin clot at the site of application, providing hemostasis and tissue sealing. When the two components mix, thrombin converts fibrinogen to fibrin, which polymerizes to form a stable clot that adheres to tissue surfaces. This mechanical seal helps control bleeding and can be absorbed by the body over time.","oneSentence":"Bioseal Fibrin Sealant is a topical hemostatic agent that forms a fibrin clot to seal tissue surfaces and control bleeding during surgery.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:43:05.721Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hemostasis and tissue sealing during general surgery"},{"name":"Hemostasis during cardiovascular surgery"},{"name":"Hemostasis during orthopedic surgery"}]},"trialDetails":[{"nctId":"NCT03847857","phase":"PHASE3","title":"Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage (PLACE030)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sun Yat-sen University","startDate":"2019-02-21","conditions":"Esophageal Anastomotic Leak","enrollment":360},{"nctId":"NCT03529266","phase":"PHASE2","title":"Study of Porcine Fibrin Sealant in Preventing Cervical Anastomotic Leakage for Esophageal or Junctional Carcinoma.","status":"COMPLETED","sponsor":"Sun Yat-sen University","startDate":"2018-06-01","conditions":"Esophageal Cancer, Gastroesophageal Junction Cancer, Anastomotic Leak","enrollment":57},{"nctId":"NCT02094885","phase":"PHASE4","title":"The Bioseal Vascular Study","status":"COMPLETED","sponsor":"Ethicon, Inc.","startDate":"2014-02-01","conditions":"Cardiovascular Bleeding, Vascular Bleeding, Hemorrhage","enrollment":252},{"nctId":"NCT02034799","phase":"PHASE4","title":"Phase IV Bioseal Study in Brain Tumor Surgery","status":"COMPLETED","sponsor":"Ethicon, Inc.","startDate":"2013-11-01","conditions":"Hemostasis, Meningioma Surgery","enrollment":256},{"nctId":"NCT01672593","phase":"NA","title":"Glue Sealing for Patients With Low-Output ECFs","status":"UNKNOWN","sponsor":"Jinling Hospital, China","startDate":"2012-05","conditions":"Low-output External Gastrointestinal Fistula","enrollment":30}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Bioseal Fibrin Sealant","genericName":"Bioseal Fibrin Sealant","companyName":"Ethicon, Inc.","companyId":"ethicon-inc","modality":"Biologic","firstApprovalDate":"","aiSummary":"Bioseal Fibrin Sealant is a topical hemostatic agent that forms a fibrin clot to seal tissue surfaces and control bleeding during surgery. Used for Hemostasis and tissue sealing during general surgery, Hemostasis during cardiovascular surgery, Hemostasis during orthopedic surgery.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":2},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}