Q & A
1. What is Microdacyn?
Microdacyn is a non-toxic, neutral-pH, Electrolyzed solution containing naturally forming hypochlorous acid and sodium hypochlorite which is FDA approved for cleaning, debriding and moistening acute and chronic wounds all kinds. The product maintains stability for 24 months.
2. Microdacyn is called a superoxidized solution or an electrolyzed solution? Are these two terms synonymous ?
Both, these terms are synonymous. Microdacyn is a superoxidized solution produced by sophisticated electrolysis process and specially designed to kill a pathogens of any kind, including antibiotic resistant bacteria such as MRSA AND VRE, also this super oxygented solution brings blood flow and reduces inflammation to any affected area while being completely non-toxic to human tissues and cells.
3. Why is Microdacyn called a superoxidized solution or an electrolyzed solution?
Superoxidized solutions, also known as electrolyzed waters, are electrochemically processed aqueous solutions manufactured from pure water and sodium chloride. In this electrolysis process, purified water and sodium chloride are submitted to an electric field. During this electrolysis process, molecules are pulled apart in a chamber with positive and negative poles, and oxygen and chlorine species (e.g. hypochlorous / hypochlorite) are formed naturally as a result of the electrolysis process
4. Is the principle behind Microcyn Technology simple?
The process is simple in concept, but the technology is highly complex. It uses a multichamber system and complicated software which must be constantly monitored by highly trained engineers. Slight deviations in the manufacturing process could impact various Microdacyn characteristics including efficacy, pH level and shelf life.
5. What are the key benefits of Microdacyn?
- Significant body of clinical evidence
- Broad-Spectrum Disinfection
- Broad-Spectrum Sanitizer
- No Special handling
- No Special disposal requirements
- Durable; one (2) two year shelf life
- No Dilution required
- No Mixing required
- Kills viruses and bacteria on hard non-porous
- inanimate surfaces and food contact areas
- Eliminates odor causing bacteria
6. On what wounds can Microdacyn be used?Microdacyn has FDA 510k approval for use on:
- Any acute and chronic wounds
- Stage I-IV pressure ulcers
- Venous stasis ulcers
- Diabetic ulcers
- Post-surgical wounds
- 2ND AND 3RD degree Burns
- Acne, Abrasions and minor irritations of the skin
7. How is Microdacyn used?
It can be applied directly to the wound or poured onto absorbent gauze pads, which are used to clean the wound. The solution can also be used to saturate gauze pads which are placed directly onto the wound. Because the solution is not irritating to the wound, it can be applied liberally and repeatedly until the wound is free of any exudate and presents a clean wound bed. It should be left on the wound and not rinsed or wiped off. You may notice that the wound tissue treated with Microdacyn becomes pink or "pinkens" with application of the solution. This is a normal and desired reaction. Once the wound bed has been cleaned, continue with next steps in the wound management protocol.
8. What is the composition of Microdacyn ingredients?
- The solution is 99.97% super oxidized water, with trace elements of
- Hypochlorous Acid (the active ingredient)
- Sodium Hypochlorite
- Sodium Chloride
- The proprietary electrolysis process used in manufacturing the solution creates the effectiveness of the solution and not solely the ingredients alone.
9. What is the active element in Microdacyn?
Trace elements of Hypochlorous Acid (the active ingredient)
10. What does pH neutral mean?
It means the solution has a hydrogen ion concentration that is neither acidic nor alkaline and is basically the same pH concentration as blood or water. This makes it as safe for human use as water or normal saline solution.
11. What does FAC mean?
FAC stands for free available chlorine. It is a measurement of the total amount of hypochlorous acid and sodium hypochlorite in the solution, and is expressed as C12. The FAC of Microdacyn is very low at 30-80 ppm
12. What is the importance of pH neutral and FAC? How is this different than competitive products?
Being pH neutral and low FAC differentiates us from our competitors as a non-cytotoxic product that causes no cytotoxicity to normal, healthy human tissues. Also, there is not another commercial electrolyzed solution with a long shelf life (i.e. > 24 months).
13. How frequently can Microcyn be used?
- At each dressing change, up to three times daily.
- If the wound has good granulation tissue established, then application should ideally be limited to once per day.
14. What is the recommended dosage?
- The dosage will vary based on the wound size and amount of exudate present.
- A mildly to moderately infected wound, less than 10cm2 in diameter, uses approximately 50-60mL of Microdacyn at each dressing change.
- Larger wounds and highly exudating wounds require a more liberal amount, similar to the amount of saline used for cleansing a wound.
- Health Care Professional’s clinical assessment should take precedent.
15. Is Microdacyn classified as sterile agent?
Yes, Microdacyn has been evaluated by the FDA to be a self-sterilizing, thus it cannot be contaminated as it is a Super-oxidized water containing ion radicals, elaborated by means of electrochemical process used as a sterilizing and antiseptic solution and hydrogel which has a wide action range to disinfect and sterilize instruments, medical equipment, and sterilization areas, as well as an antiseptic treatment for all infected and non-infected wounds Burns Microdacyn is a self-sterilizing and cannot be contaminated
16. What is the shelf life of Microdacyn?
2 years from date of manufacture, and 30 days once the bottle is opened.
17. How is Microdacyn stored?
In the original container at room temperature away from sunlight. It should not be exposed to extreme temperatures. Ideal temperature storage is 68-80 degrees Fahrenheit.
18. Is Microdacyn sensitive to heat or cold?
No special handling is required. Please Store at room temperature and keep out of direct sun light or extreme cold/freezing.
19. Can Microdacyn be used for Athletes Foot?
Microdacyn has been proven in vitro and in vivo to kill pathogens of any kind including fungal infections.
20. Can Microdacyn be used in stitches?
Yes, to cleanse the suture line. Squirt the solution directly over the stitches or use saturated gauze to cleanse the sutures. Allow the solution to remain on wound sutures prior to applying outer dressing.
21. Can Microdacyn be used on paronychia?
Yes, it can be used to clean and cure the paronychia. the infected area must be open to provide a portal for the solution to work directly on the involved tissues.
22. Are there any contraindications for Microdacyn?
Microdacyn should not be used on subjects with a history of hypersensitivity to chlorine.
23. How long does it take for Microdacyn to be effective?
Microdacyn reacts immediately to the affected area.
24. How can Microdacyn be used during debridement procedures?
Microdacyn is approved for debriding wounds and can be used as the cleansing agent to support any manual or mechanical debridement process.
25. Does Microdacyn evaporate after working on the wound?
Microdacyn is a water-based product and with time will evaporate
26. Does Microdacyn have special disposal requirements?
Microdacyn is safe to the environment. No special disposal considerations are required.
27. How does Microdacyn work?
Microdacyn is a fluid used to clean the wound, which is an initial and critical step in wound management. The solution can be applied directly to the wound with enough with any amount of force needed to remove the exudates and inflammatory debris or it can be used to saturate qauze, which is then used to clean or pack the wound, or both. It can also be used to support wound cleansing during sharp debridement or in combination with gauze as mechanical debridement
28. What microorganisms is Microdacyn effective against?
Oculus has sponsored multiple studies demonstrating that Microdacyn has broad-spectrum antibacterial, antifungal and antiviral activity in vitro. After 30 seconds of exposure in vitro, there is a significant reduction of the bacterial load (> 5 log 10) of gram positive and gram negative bacteria commonly found in skin and soft tissue infections. (See table of organism contained later in this document.)
29. Does Microdacyn damage tissues?
No, Microdacyn is gentle and safe. It is free of necrotizing chemicals. It has passed all testing on tissue sensitivity and toxicity with no irritation reported. In fact, Microdacyn based wound products have been documented to increase blood flow, increase healthy granulation, and reduce inflammation, thus accelerating healing of any kind of wound or burn
30. Does Microdacyn induce mutagenicity?
No. In-vitro testing has shown no mutagenitcy of cells when used repeatedly.
31. Does Microdacyn damage fibroblasts?
NO. Multiple independent studies have been conducted demonstrating that Micrycyn does not interrupt fibroblast function or morphology. In fact, increased Fibroblast creation and migration have been observed when Microdacyn based Products.
32. What are fibroblasts?
Fibroblasts play a critical role in wound healing. A fibroblast is a type of cell that synthesizes and deposits the extracellular proteins during wound healing, producing growth factors and angiogenic factors that regulate cell proliferation/granulation. Fibroblasts stimulate the production of collagen, providing the structural framework for many tissues. They are the most common cells of connective tissue in animals.
33. What activity or effect does Microdacyn have on fibroblasts?
- Microdacyn has been proven to increase cell proliferation and migration of fibroblasts
- Does not interfere with collagen deposition
- Microdacyn has no toxic effects on fibroblasts in skin substitutes and skin grafts tested in vitro
- Microdacyn increases the success of skin graft uptake.
- All supporting data on file: Oculus/Meschter,(2004); Gonzales (2007), Le Du (2008); Vick (2008).
34. Does Microdacyn damage DNA in fibroblasts?
- Microdacyn does NOT induce DNA oxidation of fibroblasts or accelerated aging.
- Microdacyn only degrades DNA in single-cell microorganisms like bacteria.
- In vitro testing results demonstrated that exposure of fibroblasts to MCN does not induce apoptosis, senescence, DNA oxidation or RNA degradation in fibroblasts.
- All supporting data on file: Oculus/Meschter,(2004); Gonzales (2007), Le Du (2008); Vick (2008).
35. What is a biofilm?
A biofilm is a complex cluster of microorganisms or bacteria that encase themselves in a gelatinous matrix (bioflim) over the wound, which serves as a protective shell allowing the bacteria to collect and proliferate while shielding itself against the body's immune system and antimicrobial agents. It is estimated that over 65% of microbial infections in the body involve bacteria growing as a biofilm. In chronic wounds, biofilms interfere with the normal healing process and halt or slow wound closure healing.
36. Does Microdacyn damage or destroy biofilms?
Yes. In-vitro testing shows Microdacyn is effective in destroying Pseudomonas biofilms when in contact for 30 minutes.
37. How does inflammation effect wound healing?
Inflammation is a natural event in the cascade response to tissue injury. During the inflammatory phase of wound healing, tissue debris and pathogens attract macrophages and neutrophils, which are the two main inflammatory cells. Their main function is to destroy bacteria by the process of phagocytosis. Chronic wounds tend to have prolonged or nonresolving inflammation (commonly referred to as "being stuck in the inflammatory phase"), which is believed to be the most significant factor in delayed wound healing. Therefore, in chronic wounds, reducing the excess inflammation surrounding an injury or wound is beneficial to wound healing. In vitro testing with Microdacyn has show it to inhibit the excessive cytokine response commonly found in chronic wounds. Data on file. Medina-Tomayo (2007).
38. How does TcPO2 levels effect wound healing?
The transcutaneous partial pressure of oxygen (TcpO2, or oxygen tension) reflects the amount of oxygen coming out through the skin, which in turn reflects the amount of oxygen delivered to the skin by the blood. Studies show this test to be an accurate predictor of wound outcome. Normal TcPO2 at the foot averages about 60 mmHg, but 50 mmHg or greater is considered normal. The TcPO2 can be used to assess potential blood flow in an extremity for likelihood of healing or not. TcPO2 levels of >20 mm are indicative of good healing.
39. In the realm of wound care, does Microcyn provide additional beneficial effects?
- Reduction of microbial load
- Disruption of bacterial biofilms
- Inhibition of the inflammatory response from mast cells
- Increase of the periwound Transutaneous Pressure of Oxygen (TcPO2)
- Promotion of wound healing
- Reduction of odor
- Promotes Demarcation, no maceration regardless of soak time
40. Are there any side effects or known sensitivities to Microdacyn?
- Stinging sensation reported by hypersensitive patients with arterial and venous stasis ulcers. Stinging dissipates within a few minutes and is not harmful to wound healing.
- Microdacyn versus Competitive Products
41. Does Microdacyn contain bleach? If so, how can this be OK?
- Microdacyn DOES NOT CONTAIN BLEACH
- Microdacyn has an FAC < 80 ppm which is a very low non-toxic concentration.
- this chlorine content is in the form of hypochlorous acid, not as bleach (i.e. sodijm hypochlorite). In biology, hypochlorous acid is generated in activated neutrophils by myeloperoxidase-mediated peroxidation of chloride ions, and contributes to the destruction of bacteria. Therefore, it is safe and does not harm tissue or fibroblasts.
42. How is Microdacyn different from diluted bleach?
- When bleach is diluted to an FAC < 80 ppm it is no longer effective as a cytoxic agent for microorganisms. Data on file (Thatcher 2006)
- Microdacyn solution does not contain sodium hydroxide, as does bleach, as a solution stabilizer. Sodium hydroxide is an irritant to tissues.
43. How is Microdacyn different from other super-oxidized waters?
- pH neutral
- Non-toxic, non-irritating to tissues
- Stable solution, eliminating need to manufacture onsite
- Longer self life (> 24 months)
44. How is Microdacyn different from Dakins?
- Dakins has much higher FAC levels, exceeding 2500 ppm in the .25% concentration or over 5000 ppm in the .5% concentration, which are concentrations toxic to tissues
- Dakins damages/irritates all cells, not just single cell organisms, therefore also damaging/destroying healthy tissue and fibroblasts and retarding wound healing
- Microdacyn is ready to use and requires no mixing or preparation
45. How is Microdacyn different from Hibiclens?
- Hibiclens® is a topical Chlorhexidine-based skin cleanser antiseptic that is used to eradicate germs on the surface of the skin
- Used to cleanse skin before surgery to reduce chance of infection
- Approved as a skin cleanser. Not intended to be used as a wound cleanser.
46. How is Microdacyn different from Hydrogen Peroxide (diluted to 3%)?
- 3% H2O2 is a weak acid With strong oxidizing properties
- Hydrogen peroxide (H2O2) is cyototoxic (kills cells). Microdacyn is NON-TOXIC TO HEALTHY HUMAN TISSUES AND CELLS.
- Hydrogen Peroxide Irritating to the tissues and can be disruptive to wound healing
47. How is Microdacyn different from silver solutions?
Silver is not a wound cleanser. It is a broad-spectrum antimicrobial agent only
- Silver requires long exposure time for effectiveness.
- Silver dressings are expensive
- It can cause discoloration of skin
- Toxic to healthy tissues
- Compatibility Questions
48. Is Microdacyn compatible with other products?
Microdacyn has demonstrated compatibility with all wound care products used in comprehensive wound care management. Oculus has data on file documenting compatabiiity with nearly all wound care products on the market. Also, anecdotal compatibility has been reported by healthcare providers with many products.
- Oculus tested compatibility: Gauze (polyester/rayon and cotton) products
- Anecdotal compatibility: Silver dressings (e.g. Aquacel, Convatec; Actisorb, J&J ) .
49. Is Microdacyn compatible with dermal grafts and skin substitutes?
Yes, Microdacyn is FDA approved agent to be used with all dermal graphs and skin substitutes, grafted and donor sites.
Compatibility reported for the following skin grafts and substitutes:
- Integra Bilayer Matrix Wound Dressing (Integra Lifesciences Corporation, NJ).
- Apligraft.(Organogenesis, MA)
- OASIS Wound Matrix (HEALTHPOINT, TX)
- Epifast - with keratynocytes (México)
- Hyalograft 3D - with cells (Italy)
- Laserskin autograft- with cells (Italy)
- Autologous skin grafts
50. Is Microdacyn compatible with hydrogel dressings?
Yes, based on published and anecdotal evidence, Microdacyn is compatible with hydrogel dressings.
51. Does Microdacyn deactivate silver like saline does?
Published and anecdotal compatibility has been reported for silver dressings (e.g. Aquacel, Convatec; Actisorb, J & J). We suggest cleaning/irrigating the wound with Microdacyn, then applying whatever product of your choice to the wound.
52. Is Microdacyn compatible with VersaJet, VAC, Mist, Pulsa-VAc and Jetox systems?
Yes. Microdacyn is indicated to be used in conjunction with these systems.
53. What does comprehensive wound treatment mean?
Treatment of chronic wounds is done through a comprehensive therapy and can be divided into a corrective mode followed by a maintenance mode. The corrective mode is:
- Irrigating/cleaning the wound
- Removing necrotic or callous tissue (debriding)
- Treating any edema
- Treating any infection
- Revascularizing, if poor blood flow exists
- Creating a moist wound bed environment
Maintenance mode is:
- Wound cleansing
- Keep wound environment moist
- Proper dressing management
- Compressive bandage in venous stasis
- Off-loading pressure from the wound
- Supplemental debridements, as necessary to maintain the wound bed
- Skin substitutes and other devices to support healing
- Treating underlying medical condition(s)
- Adequate nutrition to support healing
- Prevention of infection
54. What is the Standard of Care?
Standard of care in all types of wounds involves the above principles. There are some nationally approved wound care standards for certain types of wounds, such as pressure ulcers that provide greater specifics and can be found online.
55. What are the most important aspects of infection control related to wound/burn care and why?
- Control infection at the site in efforts to avoid systemic antibiotics
- Avoid spread of infection to blood stream
- Infection is identified and diagnosed based on clinical signs and symptoms.
- Wound cultures should be taken from freshly debrided wound bed
- Avoid the emergence and spread of antibiotic-resistant bacteria
56. What is most important for healthcare providers to know about selecting a wound/burn-care product?
- Intended Use
- Ease of application
- Formulary requirements and cost (i.e. pharmacoeconomics)
- Side effects
- Ability to decrease systemic antibiotics and minimizing adjuvant therapies