®
Advanced Wound Care Solution for Wound Wash, Irrigation & Debridement
NEUWATER® EASW Technology
TECHNICAL & CLINICAL INFORMATION ISO 13485 FDA 510k (K142775)
INTRODUCTION HYDROCYN aqua® is an advanced wound wash, debridement and irrigation solution for managing acute and chronic infected wounds and burns. HYDROCYN aqua® is pH neutral, biocompatible and clinically proven to be safe and effective for various types of wounds, including:
1
2
Diabetic Foot Ulcers
5
Acute Wounds
Chronic Ulcers
6
3
4
Surgical Wounds
Infected and necrotic wounds
7
Oncological Wounds
Burns (1st & 2nd Degree)
8
ADVANTAGES – “SAFE , NEUTRAL & EFFECTIVE” Decontaminates and reduces microbial load on wound Removes biofilm pH neutral Biocompatible: non-irritant and non-cytotoxic, even on eyes and throat Wound odor reduction Ready to use, no dilution required Potentially reduces use of antibiotics to treat wound infection Helps to create moist wound environment to accelerate wound healing process Can be combined with other forms of wound treatments No known contraindications
Bed Sores
NEUWATER® TECHNOLOGY HYDROCYN aqua® contains hypochlorous acid (HOCl), sodium hypochlorite (NaOCl), sodium hypochlorite (NaCl) and 99.9% Ultra Purified H2O. NEUWATER® technology which is used for HYDROCYN aqua® production utilizes a unique electrolysis process with proprietary stabilization process and does not involves any addition of chemicals. The NEUWATER® technology can be briefly described as follows: Ultra Purified H2O reacts with chloride (CI) that originates from salt (NaCl) through electrolysis process and creates:
Anode
e-
O 2 , O3 & other H2O CI2
+H2O
2CI HOCI
+HCI + NaOH NaOH
Oxidized Water Water is broken down into oxygen, ozone & other oxidizing acid Chlorine (Cl2) Reacts with water forming hypochlorous acid (HOCl. (Neutralization with NaOH converts a portion of the HOCl to NaOCl) HOCl is the active component in HYDROCYN aqua® that has antimicrobial properties.
MODE OF ACTION 1. When there is a wound, foreign contaminants or particles enter the wound. The natural body defense mechanism detects this breach and delivers red blood cells and neutrophils to the wounded area to combat against the invading pathogens. The neutrophils engulfs the pathogens through a process known as phagocytosis. Hypochlorous acid (HOCl) is a potent oxidant produced by activated neutrophils.
1
2
2. The cells of microorganism by nature are negatively charged while hypochlorous acid (HOCl) is electrically neutral. Therefore, when applied, the hypochlorous acid present in Hydrocyn aqua can penetrate the pathogens cell wall and slime layer. 3. The hypertonic Hydrocyn aqua® solution ensures that water increasingly flows into the cells to equalize the osmotic gradient. This increase in the internal pressure causes bacteria cells to burst in process known as osmotic shock. This purely physical effect ensures a highly effective reduction in pathogen load and this effect will not cause any bacterial resistance.
3
ANTIMICROBIAL EFFICACY HYDROCYN aqua® has proven antimicrobial properties against wide range of pathogens due to the presence of HOCl component. Hydrocyn aqua® is effective against gram positive and gram negative bacteria (including MRSA) fungi and spores*
Bactericidal, Fungicidal and Sporocidal Activity of HYDROCYN aqua® Antimicrobial Effect
Bactericidal
Fungicidal/Sporicidal *Tested using ASTM E2315-03 (Standard Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure) **ND: Not Detected
Microorganism
Microbial Presence
Bacillus cereus
ND (<1)
Pseudomonas aeruginosa
ND (<1)
Enterococcus faecalis
ND (<1)
Salmonella sp.
ND (<1)
Salmonella typhimurium
ND (<1)
Staphylococcus aureus
ND (<1)
Listeria sp.
ND (<1)
Legionella sp.
ND (<1)
Pseudomonas putida
ND (<1)
Aspergillus niger
ND (<1)
Yeast & mold
ND (<1)
Time-Kill Evaluation(60 sec of exposure) Classification
Microorganism
% Reduction
Bactericidal
E. feacalis, VRE
99.99%
MRSA
99.99%
Mycobacterium bovis
99.99%
Gardnerella vaginalis
99.99%
Acinetobacter baumannii
99.99%
Klebsiella pneumoniae
99.99%
Klebsiella pneumoniae, CRE
99.99%
Candida albicans
99.99%
Bacillus subtilis
99.99%
Clostridium difficile
99.99%
Clostridium sporogenes
98.45%
Trichophytan mentagrophytes
99.99%
Sporothrix schenckii
99.99%
Candida auris
99.99%
Fungicidal
Sporicidal
IN-VITRO TIME KILL STUDY Exposure time: 1 Minute
Agar Plate with Phosphate Buffered Saline (Control Sample)
Agar Plate with Hydrocyn aqua® (Test Sample)
ANTIBIOFILM EFFICACY HYDROCYN aqua® is also proven to be effective against biofilm. The in vitro test results shows that HYDROCYN aqua® capable of reducing biofilm concentration up to 99.9% Microbes
Result
Pseudomonas Aeruginosa
HYDROCYN aqua® was tested against Pseudomonas aeruginosa biofilm, The result shows a log reduction of more than 5.95 from the initial biofilm concentration and effectively reduced biofilm by 99.9%.
Methicillin-resistant Staphylococcus aureus (MRSA)
HYDROCYN aqua® was tested against MRSA. The result shows a log reduction of more than 4.4 from the initial biofilm concentration and is effectively reduced biofilm by 99%.
BIOCOMPATIBILITY
HYDROCYN aqua® has been tested for biocompatibility as per ISO 10993 & has passed following in-vivo and in-vitro studies
Biocompatibility Test
Result
Acute Dermal Toxicity
No dermal toxity
Intracutaneous Reactivity Irritation No evidence of erythema or oedema Primary Skin Test
No skin irritation
Genotoxicity
No genotoxicity effect
Cytotoxicity
No cytotoxic effect
Acute Oral Toxicity
No oral toxicity
Skin Sensitization Study
Non-sensitizing
Ocular Irritation
No ocular irritation
Vaginal Irritation
No vaginal irritation
Acute Inhalation Toxicity
No toxicity
All test done under GLP conditions and reported as per international norms
CLINICAL EVIDENCE HYDROCYN aqua® can be used for cleaning, moistening and rinsing of following types of wounds/areas:
Chronic wounds of any depth, such as diabetic foot ulcers, pressure ulcer, venous leg ulcer, bed sores
BURN WOUNDS
Acute wounds, lacerations, cuts, bite wounds, abrasions Initial Condition
Burns (up to second degree burns) Surgery wounds (intraoperative, postoperative) Infected wounds and necrotizing fasciitis Fistulas and abscesses Safe to be used on cartilage, tendons, ligaments and/or bones Safe to be used on cavities such as ear, nose, throat
1 Week After Using HYDROCYN aqua
DIABETIC FOOT ULCER Initial Condition
Initial Condition
5 weeks after using HYDROCYN aqua®
8 weeks after using HYDROCYN aqua®
POST SAUCERIZATION WOUND
POST SURGICAL WOUND
Initial Condition
Initial Condition
4 weeks after using HYDROCYN aqua速
6 weeks after using HYDROCYN aqua速
CHRONIC BLISTER
BED SORE Initial Condition
Initial Condition
1 week after using HYDROCYN aqua速
7 weeks after using HYDROCYN aqua速
COMPARISION OF HYDROCYN aqua® vs other wound care solution Description
Normal Saline
Hydrogen Peroxide
Polyhexa-methylene biguanide (PHMB)
Ocetenidine dihydrochloride(OCT)
Povidine iodine
HYDROCYN aqua®
Main Composition
Water, sodium chloride (NaCl)
Hydrogen peroxide
Polyhexamethylene biguanide
Octenidine dihydrochloride
Polyvinyl pyrrolidone (povidone, PVP)
Electro activated super-oxidized water
Antimicrobial properties
No
Yes
Yes
Yes
Yes
Yes
Anti-biofilm properties
No
Yes
Yes
Yes
Yes
Yes
Mode of action
Used as mechanical irrigation or debridement solution
Oxidation of microbial proteins and membrane lipids1, DNA damage2
Electrostatic interaction with cytoplasmic membrane, cause leakage and coagulation of cell’ cytoplasm3
Binds to glycerol phosphate in cell membrane, polysaccharides in cell wall and bacterial enzymatic systems that cause leakage of cytoplasm4
Interfere with respiratory chain of microbes. Interact with protein’ cytoplasm membrane and hamper its function3
Microbial cell lysis through osmotic shock because of the internal pressure, the cell burst
Drawbacks/ contraindication
No antibacterial properties, Edema due to excessive intake, potential for cross-contamination once the container has been opened5
Cause redness, stinging and irritation6
Cause hypersensitivity and anaphylaxis7
Cause aseptic necrosis Can cause eyes, skin, and chronic respiratory tract inflammation8 irritation and stomach distress9
No known contraindication
1. Linley, E, Denyer, S. P., Mc Donnell, G. et al. (2012). Use of hydrogen peroxide as a biocide:new consideration of its mechanisms of biocidal action. Journal of Antimicrobial Chemotherapy, 67:1589-1596. 2. Imlay, J. A., Chin, S. M., Linn, S. (1988). Toxic DNA damage by hydrogen peroxide through the Fenton reaction in vivo and in vitro. Science, 240: 640-642. 3. Maris, P. (1995). Modes of action of disinfectants. Revue Scientifique et Technique (International Office of Epizootics), 14(1): 47-55. 4. Assadian, O. (2016). Octedine dihydrochloride: chemical characteristics and antimicrobial properties. Journal of Wound Care, 25(3): S3-S6. 5. Sodium Chloride 0.9% Freeflex, Product Information (2010). 6. Hydrogen Peroxide Solution, Non-. https://www.webmd.com/drugs/2/drug-76035/hydrogen-peroxide/detail 7. Kautz, H., Schumann, H., Degerbek, F., Venemaim, L., Jakob, T (2010). Severe anaphylaxis to the antiseptic polyhexanide. Allergy, 65: 1068-1072. 8. Franz, T. and Vögelin, E. (2011). Aseptic tissue necrosis and chronic inflammation after irrigation of penetrating hand wounds using Octenisept®. The Journal of Hand Surgery, 37E(1): 61-64. 9. Material Safety Data Sheet Povidone-Iodine Solution, April, 2014.
Properties of wound antiseptics relevant for antimicrobial agents used on wounds*
Summary of clinical findings for wound antiseptics*
Supports Wound Healing
Systemic Risk
Active Substance
Antimicrobial efficacy
No
Yes
No
HOCl/NaOCl
No
No inhibition
No
Octenidine
Active Substance
Onset of Action
Depth of Effects
Bacterial Resistance
HOCl/NaOCl
30s-5 min
Shallow penetration
Octenidine Dihydrochloride
3-10hr
Superficial effect
PHMB
3-10hr
Shallow penetration
No
Yes
No
PVP-I (10%)
30 min
Deeper penetration
No
Partly inhibits
Yes
Improvement on wound healing
Peritoneal lavage
CNS Tissue
Cartilage Tissue
Yes
Yes
Possible
Possible
Possible
Yes
No Inhibition
Contraindicated
Contraindicated
Contraindicated
PHMB
Yes
Yes
Contraindicated
Contraindicated
<0.005%
PVP-I odine(10%)
Yes
Partly inhibition
Contraindicated
Toxic
Yes
Dihydrochloride
*Adapted from “Consensus of wound antisepsis: Update 2018” (Skin Pharmacol Physiol 2018;31:28–58)
GENERAL DIRECTIONS FOR USE Step 1 Preparation
Step 2 Soaking
Step 3 Cleaning
Pour Hydrocyn aqua® into the galipot / dressing set. Place some small gauzes and cotton ball and soak them in the solution
Put the Hydrocyn aqua® soaked gauze on the wound, leave it for 10-15 minutes and remove it.
Clean the wound with Hydrocyn aqua® soaked cotton ball
Step 4 Apply Gel
Step 5 Apply Gauze
Step 6 Securing The Wound
Apply Hydrocyn aqua® gel evenly to the entire wound site to moisten the wound bed.
Place a new Hydrocyn aqua® soaked gauze on the wound
Seal edges of the gauze with micropore tape. If required, bandage can be used to hold the dressing in place.
PRODUCT RANGE Product Name
Product Type / Content
HYDROCYN aqua
Bottle Spray Mist
(Solution)
HYDROCYN aqua (Gel)
HYDROCYN Wound Prep Absorbent Gauze
Product Code
Packing Quantity
100ml
HW3CE700
50 units/box
Bottle Cap Closure
250ml
HW34E100
50 units/box
Bottle Spray Mist
250ml
HW34E700
50 units/box
Bottle Cap Closure
500ml
HW35D100
24 units/box
Bottle Cap Closure
1000ml
HW36D100
12 units/box
Bag
500ml
HW35C102
24 units/box
Bag
1000ml
HW36C102
12 unit/box
Bag
3000ml
HW3EC102
12 units/box
Ampoule
25ml
HW33D100
24 units/box
Long Nozzle Tube
15g
HW40F900
20 units/box
Spray Aerosol
50g
HW42E800
50 units/box
Spray Aerosol
100g
HW4CG800
48 units/ box
10cm X 10cm
1 Gauze 8-Ply
GW3H103
25 units/box
VIGILENZ Medical Devices Sdn. Bhd. (505559-U) 308 b, Jalan Perindustrian Bukit Minyak 18 Penang Science Park, 14100 Penang, Malaysia (604) 505 4241 / 505 9841 enquiry@vigilenzmd.com www.hydrocynaqua.com / www.vigilenzmd.com