Clinical Data Library

The following summaries are intended as quick overviews to highlight the efficacy of Super-Oxidized Solutions and their placement in treatment guidelines.
For queries or further information please contact Te Arai BioFarma
 Microdacyn 

Microdacyn represents a significant advance in the topical treatment and healing of acute and chronic wounds.

 

There is scope to reduce antibiotic use, improve the time to heal and reduce amputation rates. The clinical results of Microdacyn and associated references can be found below

 

There is growing clinical evidence to support the use of Microdacyn and Microdacyn Hydrogel to improve wound management outcomes. Microdacyn has been shown to have a strong safety profile and is likely more effective than currently used wound cleansers/topical antimicrobials.

 

Microdacyn is a non-cytotoxic antimicrobial and as such is clinically preferred compared to cytotoxic antimicrobial agents.

 Microdacyn Is Included In the Following Guidelines 
 
 
  • International Wound Infection Institute (IWII) Clinical Practice update 2016

The Guidelines note super-oxidised solution are purported to disrupt biofilm and kill planktonic bacteria and other organisms while being safe for the wound and the individual.
In regard to biofilms SOS “Penetrates biofilm rapidly, killing formations from within”.
Antiseptic wound cleansers of low toxicity are recommended for prevention of infection in individuals at increased risk. Increased risk patients are defined (Table 2).

 

 

 

  • Expert Recommendations for the use of Hypochlorous Acid Solution: Science and Clinical Applications (2016)

Panel recommendation 1: Cleanse the wound with HOCL, followed by debridement, if needed. Follow a standard algorithm to prepare the wound bed, such as TIME.

Panel recommendation 2: Treat infection wounds with HOCL by integrating into best practices according to wound etiology.

Panel recommendation 3: For infected wounds, treat with HOCL for 15 minutes either intralesionally or by ensuring the wound is covered with solution.

 

Indications for use of HOCL:

DFUs, VLUs, PUs, Post-surgical wounds, First and Second-degree burns, Grafted donor sites.

 

 

  • World Healing Society Guidelines Update: Diabetic Foot Ulcer treatment Guidelines (2016)

Guideline #4.3. Wounds should be cleansed initially and at each dressing change using a neutral, non-irritating, non-toxic solution. Routine wound cleansing should be accomplished with a minimum of chemical and/or mechanical trauma. (Level III) To be read in conjunction with a strong recommendation for debridement.

Only two clinical studies were cited as Updated Evidence relevant to Guideline 4.3. The SOS study of Adam Landsman et al, 2011 and the SOS study of A. Piaggesi et al, 2010.

 Evidence of Antimicrobial Mechanism 
 
 

The effects of SOS on bacterial cells has been directly observed using transmission electron microscopy, atomic force microscopy and fluorescence microscopy which has provided evidence of the direct effects on the bacterial cell envelope. Once within the bacterial cell, SOS have been shown to cause the total destruction of chromosomal plasmid DNA, RNA and proteins. 

 

SOS has a high oxidation-reduction potential which results in an unbalanced osmolarity between the ion concentrations in the solution and that within unicellular organisms, further damaging membrane structures this causes increased membrane porosity, enabling oxidising moieties (present in excess in SOS) to penetrate in the the cell cytoplasm, ultimately leading to the inactivation of cellular protein, lipids and nucleic acid, rendering the cell non-functional (R. M. Thorn, 2012)

Download the full article here
 Non-Irritating | pH Neutral | Non-Cytotoxic 
 
An ideal wound cleanser provides periodic reduction of bacterial contamination and removal of debris without adversely impacting cellular activities vital to the wound healing process
 
Microdacyn breaks the traditional paradigm in weighing up healing disruptions with aggressive infection control.
 
This might seem simple but we have been using very aggressive antiseptics on wounds for a long time and its time limit their use where possible.

The latest revision of the International Wound Infection Institute (IWII 2016) does not recommend Hydrogen Peroxide
Toxicity of antiseptics table
(S.A. Rani et al, 2014)

19 wound and skin cleaning products were compared across  in-vitro cytotoxicity and antimicrobial activity. SOS was found to be:

10 times less cytotoxic than Prontosan solution,

1,000 times less cytotoxic than chlorhexidine gluconate and Betadine.

 

At a SOS concentration that is completely non-cytotoxic as measured by L929 fibroblast cells SOS reduced S. aureus by at least 4 log within 30 minutes.

By contrast non cytotoxic Prontosan, betadine and chlorhexidine failed to achieve a 4 log kill at 24 hours.

 TcPO2 & Oxygen Supply 
 
Microdacyn is documented in more than 10 years of studies to increase the local transcutaneous oxygen pressure (TcPO2) after the wound has been saturated in Microdacyn.
 
By increasing the amount of available oxygen to the wound while healing may reduce the wound time to heal.
In patients that are high-risk such as diabetic, this benefit may be more significant to healing outcomes.
 
Please see the table of average mmHg increases in 897 patients based on their comorbidities
You will see that even with a 30-second application of Microdacyn the TcPO2 may be sustained for up to 72 hours*
*Not including active smokers (AS)
TccPO2 measures

(Cheryl M.Bongiovanni, 2006)

A single 60 second application of the SOS to a wound surface showed a significant increase in the TcPO2 measure 5mm from the wound, i.e. increasing from 35 mmHg prior to application to 89 mmHg for up to 36 hours following the single 60 second application

In another patient a single 60 second application of SOS to a wound surface showed a significant increase in TcPO2 measure 10mm from the wound i.e. increasing from 29 mmHg prior to application to 80 mmHg and sustained for 48 hours following the single 60 second application

(Cheryl M. Bongiovanni, 2016)

100% of the 1249 venous leg ulcers treated with SOS were healed completely at the completion of the trial, the average healing time was 28.20 days for the venous leg ulcers treated with SOS, this is compared to 165.2 days which was the cited average time of healing of venous leg ulcers (Wounds Int 2016)

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