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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.

 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)

 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 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.

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 Advantages to the patient using Microdacyn 
Improved wound outcomes in terms of time to wound healing, reduction in antibiotic use, reduction in need for subsequent surgical debridement and amputation with subsequent improved quality of life (QoL)
  Microdacyn (SOS) has been shown in the following clinical trials to improve wound healing:
 Advantages List Breakdown By Benefit In Wound Management
  • Improve wound bed oxygen supply (TcPO2)


(Bongiovanni, 2006. Bongiovanni, 2016)
 

  • Reduce the requirement for concomitant antibiotic use to manage infection


(Adam Landsman, 2011)
 

  • Reduce pain associated with wound cleansing


(Ariel Miranda Altamirano, 2006)
 

  • Reduced wound associated malodour


(Fermın R Martınez-De Jesus, 2007)
 

  • Reduce post-surgical infection rate


(Javier Aragón-Sánchez, 2013)
(Chiara Gotetti, 2007)
(Abdul Ramzisham Rahman Mohd, 2010)
(A. Piaggesi MD, 2010)

 

  • To be at least as effective as certain oral antibiotics for treatment of mild diabetic foot infections


(Adam Landsman, 2011)

 

  • Improve infection control


(Javier Aragón-Sánchez, 2013)
(R. K. Chittoria, 2007)

(Chiara Gotetti, 2007)
(Luca Dalla Paoloa, et al., 2006)
(Elia Ricci, 2007)

 

  • Reduce wound healing time


(Cheryl M. Bongiovanni, 2016)
(Ning Fanggang, 2008)
(Chiara Gotetti, 2007)
(Syed Fazle Hadi, 2008)
(Marwaha, 2010)
(Fermın R Martınez-De Jesus, 2007)
(P K Pandey, 2011)
(Luca Dalla Paoloa, et al., 2006)
(A. Piaggesi MD, 2010)

 

  • Improve wound bed granulation


(Cheryl.Bongiovanni, 2006)
(Fermın R Martınez-De Jesus, 2007)
(P K Pandey, 2011)

 

  • To be a wider spectrum antimicrobial compared to commonly used topical-antimicrobials


(Ariel Miranda Altamirano, 2006)
(Abdul Ramzisham Rahman Mohd, 2010)
(C. Landa-Solis, 2005)

 

  • Reduce patient length of stay


(Ariel Miranda Altamirano, 2006)
(Syed Fazle Hadi, 2008)
(Elia Ricci, 2007)

 

  • To be non-cytotoxic

 

(S.A. Rani et al, 2014)
(Javier Aragón-Sánchez, 2013)
(Fermın R Martınez-De Jesus, 2007)
(Luca Dalla Paola, et al., 2006)
(J. Medina-Tamayo, 2007)

 Article Summary & Full Article Link 
 
(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.

(Javier Aragón-Sánchez, 2013)

Limb salvage was achieved in 100% of patients (with osteomyelitis) treated with SOS

Infection was eradicated in 100% of patients included in this trial and every wound healed; average healing time was 6.21 week.

Only one recurrence was detected and this patient was treated with SOS and no amputation was required to date in the singular complicated case.

(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)

(R. K. Chittoria, 2007)

At the start of the trial 100% of wounds were infected, after 5 days use of SOS 95% of wound became uninfected and only 5% infected.

40% of the wounds were healed by simple wound care by the use of SOS as a wound cleanser, while 55% underwent skin graft surgery and 5% flap procedures once the wounds were uninfected and the wound bed was composed of healthy granulation tissue which was attained following the use of SOS.

None of the patients suffered from noticeable complications during or following the use of SOS.

(Nina Fanggang, 2008)

The average wound healing time in partial thickness burns  was 20.00 days +/- 2.7125 for those patients treated with SOS, compared to 22.1 days +/- 3.007 for the patients in the control group of SSD (Silver Sulfadiazine cream)

(Chiara Goretti, 2007)

Minor amputations were significantly more common in patients treated with Povidone-Iodine, who also experienced significantly slower healing time (212.3 days vs 144.6 days for the SOS group)

In the SOS group 87.5% of patients had healed lesions at 6 months compared with 51.4% of the povidone-iodine group

Patients treated with SOS required antibiotic therapy for a significantly shorter time i.e. mean of 74.7 +/- 32.1 days compared to the historical control 129.6 =+/- 54.4 days and had fewer reinfections (4 SOS group vs 9 PI group) and less need for repeated debridement.

(Syed Fazle Hadi, 2008)

61.76% of patients assigned to the SOS treatment had an improvement / downgrading from stage IV (necrotic tissue) to stage I (healthy epithelization) while only 14.7% in the control group showed such improvement.

62% of patients assigned to the SOS treatment had the shortest length of (1-7 days) compared to only 20% of the patients assigned to the control group (saline, p<0.05), and only 6% of patients assigned to the SOS treatment had the longest length of stay  (>21 days) compared to 16% of patients assigned to the control group (p<0.05)

(Marwaha, 2010)

At the 5 day follow up the average reduction in periwound oedema / erythema in the SOS group was 75% as compared to 40% in the control group (Iodine sol) – Treatment of acute abscesses

At the 12 day follow up the average increase in granulation tissue and epithelialization tissue on the SOS group was 80% as compared to 60% in control group (Iodine solution) – Treatment of burns

At the 21 day follow up the average reduction in wound size in the SOS group was 70% compared to 50% in the control group (Iodine solution)

(Adam Landsman, 2011)

55% of mildly infected DFU patients assigned to the SOS alone group experienced complete resolution of infection at the 4 day of treatment compared with only 28.6% of patients treated with saline as a cleanser and oral levofloxacin.

 

The patient group being treated with SOS and oral levofloxacin had a complete resolution of infection in 44% of patients.

(Fermın R Martınez-De Jesus, 2007)

100% of patients assigned to the SOS treatment group achieved elimination of wound odour compared with only 25% of those in the control group (saline)

80.9% of those treated with SOS achieved improvement and stabilisation of cellulitis compared with only 43.7% of those in the control group.

Positive improvement (increased %) in wound granulation tissue was observed in 90.4% of those treated with SOS with only 62.5% of patients in the control displaying such improvement

Both groups were concomitantly treated with parenteral broad spectrum antimicrobial medication and oral antibiotics until cellulitis had resolved, the average length of oral antibiotic treatment was 26+/- 3.1 days for the SOS group compared 30 +/- 5.2 for the control group.

(Abdul Ramzisham Rahman Mohd, 2010)

Patients in the SOS group had significantly lower incidence of surgical site infections i.e. 5.7% compared to the control group (Iodine solution) which had an incidence rate of 15.6%.

(P K Pandey, 2011)

The incidence of surgical site infection was 15% in the SOS group and 36% in the control (povidone Iodine sol) group. Healing in terms of decreased wound surface area after 1 week of dressing was 20.17% in the SOS group compared to 13.83% in the control group

(Luca Dalla Paola, et al., 2006)

97 of the 110 patients (88.2%) assigned to the SOS treatment had no bacteria cultured from their ulcer compared to 74 of 108 (68.5%) treated with povidone-iodine.

13 bacterial strains were cultured from patients in the SOS group vs 43 in the control group (Povidone Iodine)

The number of patients having conservative surgery, minor amputations and major amputations were 60 (54%), 45 (435) and 5 (5%) respectively, in the SOS group and 47 (44%), 51 (47%) and 10 (9%) respectively in the povidone-iodine group.

The median healing time post-surgery was 43 days in the SOS group and 55 days in the povidone-iodine group.

No patients treated with SOS experienced a local reaction, whereas 16.7% of those treated with povidone-iodine group had a skin rash or some other adverse event

(A. Piaggesi MD, 2010)

The healing rate at 6 months was 90% in the SOS group compared with 55% in the control (PI)

The healing time was 10.5 weeks +/- 5.9 weeks in the SOS group compared to 16.5 weeks +/- 7.1 weeks in the control (PI)

After 1 month of treatment, the number of bacteria persistent in the wounds of the SOS group showed a reduction of 88% compared to a 11% reduction in the control group (PI)

The duration of antibiotic therapy was 10.1 weeks +/- 6.1 weeks in the SOS group compared to 15.8 weeks +/- 7.8 weeks in the control (PI)

20% of patients in the SOS group required intervention during follow up compared with 55% in the control group (PI)

(Elia Ricci, 2007)

Patients assigned to the SOS treatment group required average of 5.4 days of treatment until infection had resolved compared to the 7.9 days in the control group (PI)

Patients assigned to the SOs group had improvements in wound malodour in 2 days compared to 19 days in the control group,


The average length of stay (hospitalization) in the SOS group was 8.2 days (range 7-10) compared to 12.3 days (range 8-19) in the control group.

As both groups were concomitantly treated with parenteral broad spectrum antimicrobial medication the control group had an additional 2.5 days of parenteral broad spectrum antimicrobial therapy.

The data encompasses findings from Super-Oxidized Solutions trials from all over the world that in some cases are under different brand names and variations in formulation.
Please contact Te Arai BioFarma for clarification if required
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