A New Standard of Care for Wound Irrigation

Irrisept Antimicrobial Wound Lavage is a single-use, self-contained irrigation device. Irrisept contains 0.05% chlorhexidine gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP). The solution is aseptically filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the bottled solution. Irrisept can be delivered through manual compression or spikeable/instillable connections with powered irrigation devices. Irrisept is a Class II Medical Device and an unclassified Combination Product.

CHG is chlorhexidine gluconate. It is a cationic bisbiguanide salt. CHG works by destroying the bacterial cell membrane and precipitating cell contents. The attraction of the positively charged CHG molecule to negatively charged bacterial cell wall causes disruption of the cell membrane and subsequent cellular death.¹ CHG acts as a preservative to help inhibit microbial growth in the bottled solution.

The Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt, and foreign materials, including microorganisms from wounds.

Irrisept is designed to meet the American College of Surgeons’ recommendations for low pressure irrigation (1-15psi).²

Irrisept can be used for all types of wounds.

Irrisept features an extensive safety profile with in-vivo and in-vitro testing and RCT data.^3,4 It has over 12 years of proven history and testing and has been referenced by name and/or concentration in independent publications.^3-14

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 debridement³:

• Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic Toxicity
• Material Mediated Pyrogens

Reports and testing on file at Irrimax Corporation.

WARNINGS

• Do not use this product if the patient is allergic to chlorhexidine gluconate.
• Discontinue use immediately if irritation, sensitization, or allergic reaction occurs.

CAUTIONS

• Do not use unless solution is clear and bottle twist seal is intact.
• When using this product keep away from eyes and ear canals. If solution inadvertently contacts these areas, rinse out promptly and thoroughly with water and/or normal saline.
• Not for injection.
• Single patient use only.
• Irrisept is intended for use in adults by healthcare professionals only.
• Irrisept solution meets biocompatibility guidelines for ≤ 24 hours contact with breached or compromised surfaces (ISO 10993-1).

Irrisept is a prescription device. FDA regulations require that prescription devices have the following statement “Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.” 

Irrisept solution is manufactured using aseptic processing per ISO 13408 Aseptic Processing of Healthcare Products. The bottle, accessories, and packaging for the ISEPT-450-USA, ISEPT-150-USA, and ISEPT-AK-USA are EO sterilized.

Labeling on all Irrisept products states: “Wait for approximately one minute, rinse with normal saline for irrigation. Discard any unused solution.”

Labeling on all Irrisept products states: “Single patient use only” along with “single use only, do not reuse” symbol.

Labeling on all Irrisept products state storage temperature is between 10°–30° degrees Celsius (50°–86° Fahrenheit).

Irrisept maintains a 3-year shelf life from the date of manufacture, which is indicated on the product packaging or IFU insert.

The expiration date may be located at the top of the Irrisept product insert or on a sticker on the pouch or box.

If desired, the Irrisept Antimicrobial Wound Lavage may be warmed in its packaging up to 43°C (110°F) by placing it in a temperature warming cabinet for up to 15 days prior to use.¹⁵ Note: Prior to warming, store the device as per the device labeling.

Each LOT of Irrisept is tested to meet a pH range of 5.0 to 7.0.

1. Bowler, P. et al. (2001). Wound Microbiology and Associated Approaches to Wound Management. Clin Micro Review, 244- 269.https://doi10.1128/CMR.14.2.244-269.2001

2. Lewis, K., & Pay, J. (2021, January). Wound Irrigation. NCBI Bookshelf. https://www.ncbi.nlm.nih.gov/books/NBK538522/

3. (2022). KTK Summary. Doc. 537161 V5 Evaluation of CHG as a preservative in the solution

4. Biocompatibility Matrix. Data on file at Irrimax Corp. Lawrenceville, GA

5. (2022). Protocol CLP-01: An Independent Review of Safety Data From a Closed Clinical Study Using Irrisept (Protocol # IRR-CT-901-2013-01)

6. Spencer et al. (2017). Reduction in Colon Surgical Site Infections Using CHG Irrigant Solution [Conference Presentation]. AORN 2017, Boston, MA

7. Truitt, K., & Kleinheinz, S. (2017). Target Zero: Eliminating Surgical Site Infection With 0.05% CHG Jet Lavage Irrigation [Conference Presentation]. AORN 2017, Boston, MA

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. Data on file at Irrimax Corp., Lawrenceville, GA

15. Ashley et al. (2014). Acute Wound Care. ACS Surgery: Princ Prac . (7th ed., pp. 215–216). Decker Intellectual Properties Inc.

16. International Wound Infection Institute (IWII). (2022 update). Wound Infection in Clinical Practice: Principles of Best Practice. International Consensus Update. pp. 26-27

17. McDonnell, G. & Russell, A.D. (1999). Antiseptics and Disinfectants; Activity, Action and Resistance. Clin Micro Rev, 12(1), 147-179. doi.org/10.1128/cmr.12.1.147