Clinical Overview
IrriSept and IrriSept O.R. are the only FDA-Cleared Cleansing and Debridement systems containing Chlorhexidine Gluconate (CHG), the active ingredient in a wide range of infection prevention products, including Chloraprep and Hibiclens.
- IrriSept passed the FDA required tests for cytotoxicity, skin irritation and immune (allergic) response.1
- CHG, at the 0.05% concentration used in IrriSept, has been demonstrated to be effective in laboratory testing against a broad spectrum of bacteria, fungi and viruses.2,3
- Laboratory studies: Studies demonstrate that CHG at 0.05% kills rapidly upon contact and additionally displays residual properties that inhibited MRSA and Coag-Neg Staph growth for 14 days.3 Laboratory studies conducted with the use of IrriSept can be accessed here.
- Case Reports: IrriSept and IrriSept O.R. have been used in thousands of surgical and non-surgical procedures. Eight case reports, covering a variety of applications may be accessed here.
- Educational Video: An educational video, showing the use of IrriSept on a MRSA infected abscess may be accessed here.
Sources
1. Biocompatibility compliance tests completed per FDA's Blue Book Memorandum G95-1 and ISO 10993-1, Biological Evaluation of Medical Devices, on file at IRRIMAX Corporation
2. Laboratory Testing Records per USP<51>, Antimicrobial Effectiveness Testing, on file at IRRIMAX Corporation
3. Laboratory Testing Records, "Chlorhexidine Gluconate (CHG) Bacterial Study Report," on file at IRRIMAX Corporation
