kit DAC - Implantable-device infection control barrier

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgængelig fra:

Novagenit Australia Pty Ltd

Klasse:

Class III

Fremstillet af:

Novagenit Srl Viale Trento 115/117 ?, Mezzolombardo, Trentino, 38017 Italy

Terapeutisk område:

61057 - Implantable-device infection control barrier

Terapeutiske indikationer:

100% cross linked hyaluronic acid with poly DL-lactide powder hydrated before use with an antibiotic solution. Other elements provided are sterile empty syringe, sterile accessories for hydration & uniform application onto the surfaces of the implant. Antibiotic loading of hydrogel destroys bacteria kept in planktonic state by temporary coating and complements systemic antibiotic dose by generating high local concentration at the implant site. Biodegradable and absorbed in less than 7 days. KIT DAC is a product designed for the preparation and application of a bio-resorbable hydrogel coating mixed with antibiotics to be used in orthopaedics and traumatology for prevention of surgical site infections. The product in combination with an antibiotic is specifically indicated in orthopaedics and traumatology as a preventive measure against bacterial adhesion, colonization (which is cause of bacterial infections) on the implant surface in the very early time window after implantation. DAC is an antibacterial coating indicated to be applied on uncemented prostheses and on trauma devices. - When considering whether to use DAC, patient selection must be balanced between patient risk factors / co-morbidities and responsible antimicrobial stewardship. - DAC is indicated to deliver antibiotics for primary or secondary prevention of deep periprosthetic infection in patients of both sexes 18+ years of age who have an elevated risk of such infection in the following surgeries: o Patients undergoing second stage (aseptic) uncemented or hybrid hip and knee arthroplasty for periprosthetic infection o Patients undergoing primary uncemented or hybrid hip and knee arthroplasty in groups known to be risk for infection including: * Class 2 or Class 3 Obesity (BMI > 35) * ASA 2+ o Patients undergoing Orthopaedic Long Bone Fracture fixation <7 days from injury o Patients undergoing all-cause revision surgery, with the same risk factors as the primary arthroplasty population