Bioscience Labs Inc. (now part of Nelson Labs), an independent testing organization, used the In-Vitro Kinetic Time-Kill Method to evaluate the properties of Irrisept solution containing 0.05% chlorhexidine gluconate (CHG) when challenged with several different microorganism species. CHG acts as a preservative to inhibit microbial growth in the bottled solution. All testing was performed in accordance with Good Laboratory Practices, as specified in FDA 21 CFR Part 58.1
Studies
Safety Studies
Irrisept features an extensive safety profile with in-vitro and in-vivo studies and RCT data, with >12 years of proven history and testing.1-3
Irrisept meets biocompatibility guidelines for ≤ 24 hours contact with breached or compromised surfaces following the ISO standard 10993-1. The following testing supports biocompatibility of Irrisept for the intended use of wound cleansing and debridement:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogens
Reports for all testing stated above are on file and available upon request through Irrimax Corporation.
Publications
Irrisept is referenced by name and concentration in independent publications.4-11
Research Program
Irrimax Corporation supports research involving Irrimax products to help identify new ways to help treat patients and prevent infections, reduce healthcare costs, and improve patient outcomes and the safety of healthcare professionals.
Irrimax is committed to sharing clinical data with healthcare professionals, patients, policymakers, and the public.
To learn more about our research program, please email us and we will connect you with a clinical team member.
Irrisept is intended for mechanical cleansing and removal of debris, dirt, and foreign materials, including microorganisms from wounds.
Warning: Do not use this product if the patient is allergic to chlorhexidine gluconate. Discontinue use immediately if irritation, sensitization, or allergic reaction occurs.
Research Program
Irrimax Corporation supports research involving Irrimax products to help identify new ways to help treat patients and prevent infections, reduce healthcare costs, and improve patient outcomes and the safety of healthcare professionals.
Irrimax is committed to sharing clinical data with healthcare professionals, patients, policymakers, and the public.
To learn more about our research program, please email us and we will connect you with a clinical team member.
Irrisept is intended for mechanical cleansing and removal of debris, dirt, and foreign materials, including microorganisms from wounds.
Warning: Do not use this product if the patient is allergic to chlorhexidine gluconate. Discontinue use immediately if irritation, sensitization, or allergic reaction occurs.
References
1. (2022). KTK Summary. Doc. 537161 V5 Evaluation of CHG as a preservative in the solution
2. Biocompatibility Matrix. Data on file at Irrimax Corp. Lawrenceville, GA
3. (2022). Protocol CLP-01: An Independent Review of Safety Data From a Closed Clinical Study Using Irrisept (Protocol # IRR-CT-901-2013-01)
4. Spencer et al. (2017). Reduction in Colon Surgical Site Infections Using CHG Irrigant Solution [Conference Presentation]. AORN 2017, Boston, MA
5. Truitt, K., & Kleinheinz, S. (2017). Target Zero: Eliminating Surgical Site Infection With 0.05% CHG Jet Lavage Irrigation [Conference Presentation]. AORN 2017, Boston, MA
6. Dotson, N., Rasheid, S., Marcet, J., & Sanchez, J. (2015). In Irrigation of Incisions With 0.05% CHG Reduces Surgical Site Infections in Colorectal Surgery [Conference Presentation]. ASCRS 2015, Boston, MA
7. Merceron et al. (2019). Comparison of Complications Following Implant-Based Breast Reconstruction Using Triple Antibiotic Solution Versus Low Concentration Chlorhexidine Gluconate Solution. Mod Plas Surg, 09(04), 74-85. https://doi.org/10.4236/mps.2019.94010
8. Mangold et al. (2019). Standardising Intraoperative Irrigation with 0.05% Chlorhexidine Gluconate in Caesarean Delivery to Reduce Surgical Site Infections: A Single Institution Experience. J Peri Practice, 30(1-2), 24-33. https://doi.org/10.1177/1750458919850727
9. Lung et al. (2022). Chlorhexidine Gluconate Lavage During Total Joint Arthroplasty May Improve Wound Healing Compared to Dilute Betadine. J Exp Ortho, 9(1). https://doi.org/10.1186/s40634-022-00503-w
10. Driesman et al. (2020). Perioperative Chlorhexidine Gluconate Wash During Joint Arthroplasty has Equivalent Periprosthetic Joint Infection Rates in Comparison to Betadine Wash. J Arthroplasty, 35(3), 845-848. https://doi.org/10.1016/j.arth.2019.10.009
11. Frisch et al. (2017). Intraoperative Chlorhexidine Irrigation to Prevent Infection in Total Hip and Knee Arthroplasty. Arth Today, 3(4), 294- 297. https://doi.org/10.1016/j.artd.2017.03.005