{"id":"antibiotic-cement-bead-pouch","safety":{"commonSideEffects":[{"rate":null,"effect":"Local inflammatory response"},{"rate":null,"effect":"Allergic reaction to antibiotic components"},{"rate":null,"effect":"Device-related complications (migration, retention)"}]},"_chembl":{"chemblId":"CHEMBL606111","moleculeType":"Small molecule","molecularWeight":"1040.49"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The device consists of polymethylmethacrylate (PMMA) cement beads loaded with antibiotics (typically vancomycin and/or gentamicin) contained within a dissolvable pouch. When placed at the surgical site, the beads elute antibiotics locally over time, achieving bactericidal concentrations while minimizing systemic exposure. The pouch allows for easy placement and removal while the beads provide sustained antimicrobial activity at the infection site.","oneSentence":"An antibiotic-impregnated cement bead pouch that delivers high local concentrations of antibiotics directly to surgical sites to prevent or treat bone and soft tissue infections.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:42:43.666Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention and treatment of surgical site infections in orthopedic procedures"},{"name":"Bone and soft tissue infections following trauma or surgical intervention"}]},"trialDetails":[{"nctId":"NCT05615844","phase":"PHASE3","title":"Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy","status":"RECRUITING","sponsor":"University of Maryland, Baltimore","startDate":"2023-11-05","conditions":"Open tíbia Fracture","enrollment":312}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Antibiotic Cement Bead Pouch","genericName":"Antibiotic Cement Bead Pouch","companyName":"University of Maryland, Baltimore","companyId":"university-of-maryland-baltimore","modality":"Small molecule","firstApprovalDate":"","aiSummary":"The Antibiotic Cement Bead Pouch is a treatment modality used for managing severe open tibia fractures, and it involves the use of small molecule antibiotics embedded in a cement bead. It has been compared to Negative Pressure Wound Therapy in a randomized controlled trial for the management of severe open tibia fractures.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}