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Microcyn Bladder Treatment (An Open Letter to Dr. Young)

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    Originally posted by nancygail View Post
    Dr.Wise, do you endorse the use of microcyn for wound treatment?It is FDA approved and available to physicians for this use.
    Nancy,

    I simply don't know enough about this treatment to endorse it. I recently talked to a man who is an investor in this technology and told him that I thought the company should be doing clinical trials to show that it is effective. To my knowledge, this treatment is not FDA approved for wound treatment. If anybody find out otherwise, please post the information.

    Wise.

    Comment


      It is approved via a 501K compared to a predicate device. This is directly from the FDA's website see: http://www.accessdata.fda.gov/cdrh_d...f9/K093585.pdf section 5.5 and page 9 (of 37) for the formal approval of that indication.
      Wife of Chad (C4/5 since 1988), mom of a great teenager

      Comment


        There have been a whole series of 501k clearances for both Microcyn liquid and gel, including negative pressure therapy--dating from around 2005, maybe earlier. I'll try to get the full list from Oculus.
        I'm back on Facebook again--up and running!

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        Comment


          I simply don't know enough about this treatment to endorse it.
          It's difficult for me to comprehend how the vast amount of material about Microcyn and wound care posted on this forum has somehow escaped the notice of it's moderators. Perhaps I just don't realize how busy you all are in your occupations. This must be volunteer work done here. At any rate, allow me to re-post some pertinent info. The following audio/video material gives a lot of good info:

          http://www.oculusis.com/mexico/mp/video.php

          And these articles give some of the basics:

          http://www.woundsresearch.com/files/...72706_occu.pdf
          I'm back on Facebook again--up and running!

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          Comment


            Originally posted by Leila View Post
            It's difficult for me to comprehend how the vast amount of material about Microcyn and wound care posted on this forum has somehow escaped the notice of it's moderators. Perhaps I just don't realize how busy you all are in your occupations. This must be volunteer work done here. At any rate, allow me to re-post some pertinent info. The following audio/video material gives a lot of good info:

            http://www.oculusis.com/mexico/mp/video.php

            And these articles give some of the basics:

            http://www.woundsresearch.com/files/...72706_occu.pdf
            Leila,

            Thank you for these links. I had not seen these before and they reassure me that there is indeed better research being done with Oculus Microcyn.

            I searched internet for FDA approval of Oculus products and have found that two Oculus products received FDA 510(k) approvals:
            1. in 2011 for Atopic dermatitis, radiation dermatitis, and other skin dermatitis

            2. In 2005 for cleansing and debriding of acute and chronic wounds.

            According to an article in 2009 by Adam Feuerstein entitled, "Oculus Sidesteps FDA rules with wound cleaner", the company "appears to be skirting U.S. drug laws by claiming that its wound cleansing product containing common diluted bleach has drug-like therapeutic properties. The U.S. FDA approved Microcyn as a wound cleaner under the agency's regulation of simple medical devices known as 510(k) approvals but Oculus is marketing Microcyn as a drug with specific medical claims such as eliminating infections, accelerating wound healing, and reducing inflammation in patients with diabetic ulcers."

            The document that you linked with http://www.woundsresearch.com/files/...72706_occu.pdf is a supplement to the January 2006 issue of Wounds (A Compendium of Clinical Research and Practice". It contains a series of articles by doctors who used Microcyn to treat a variety of wounds. I read the articles and was impressed but was not persuaded that these are true clinical trials that would pass muster at the FDA to support the medical claims of the company and that you seem to be making here.

            I had previously done a literature search for information concerning superoxidized solutions and had found relatively few studies because I was searching for Microcyn and superoxidized water.

            1. Sauer K, Thatcher E, Northey R and Gutierrez AA (2009). Neutral super-oxidised solutions are effective in killing P. aeruginosa biofilms. Biofouling 25: 45-54. Department of Biological Sciences, Binghamton University, SUNY at Binghamton, Binghamton, NY, USA. ksauer@binghamton.edu. Bacteria growing in biofilms can become up to 1000-fold more resistant to antibiotics and biocides as compared to their planktonic counterparts. As a result of this increased resistance, biofilms and biofilm-related infections cannot be effectively treated with conventional antibiotic therapy. The goal of this study was to determine the efficacy of three neutral pH, super-oxidised solutions (nSOSs, OIS-80, OIS-125, OIS-200, Microcyn Technology) varying in oxychlorine concentration (80, 125 and 200 ppm) against P. aeruginosa grown planktonically and as biofilms. Exposure for 20 s of exponential phase cells to any of the three solutions was sufficient to reduce viability by more than five logs. However, only exposure for 10 min to OIS-125 and OIS-200 for 10 min was sufficient to eradicate stationary phase P. aeruginosa cells. The efficacy of nSOSs on P. aeruginosa biofilms, grown to maturity in continuous flow tube reactors, was determined upon treatment up to 60 min. Viability pre- and post-treatment was determined by CFU counts. The effect of these solutions on P. aeruginosa biofilms and biofilm architecture was further visualised by confocal scanning laser microscopy and quantitatively analysed by COMSTAT. Under these experimental conditions, only OIS-125 and OIS-200 achieved a >3-log reduction and biofilm disaggregation within 30 min of exposure. Because OIS-125 and OIS-200 enhance the disaggregation of biofilms, their use in the treatment of surface-related biofilm infections deserves further investigation.

            2. Gonzalez-Espinosa D, Perez-Romano L, Guzman-Soriano B, Arias E, Bongiovanni CM and Gutierrez AA (2007). Effects of pH-neutral, super-oxidised solution on human dermal fibroblasts in vitro. Int Wound J 4: 241-50. Cell Therapy Unit, Instituto Nacional de Rehabilitacion, Mexico City, Mexico. For the past 20 years, super-oxidised solutions (SOSs) have been shown to be potent antimicrobials and disinfectants via oxidative damage. However, the potential toxicity of SOSs on eukaryotic cells has not been documented in vitro. This is relevant because oxygen and chlorine reactive species may possibly induce ageing and irreversible cellular dysfunctions that eventually produce cell death. The present study investigates the cytotoxicity and oxidative stress induced by a novel, pH-neutral SOS (i.e. Microcyn, MCN) on young, primary diploid - human dermal fibroblast (HDF) cultures. For this purpose, hydrogen peroxide (HP) was used as a positive control of oxidative damage. When these solutions were used at concentrations indicated for wound care (i.e. undiluted MCN or 880 mM HP), HP was significantly more toxic than MCN. After 5 and 30 minutes of exposure, cell viability was 38% and 5%, respectively, in 880 mM HP-treated cells versus 75% and 70% in MCN-treated populations, respectively. HP induced both apoptosis and necrosis, whereas MCN induced only necrosis. Genotoxic and ageing studies were then conducted at sublethal HP concentrations as previously reported in the literature. Cellular DNA and RNA were partially degraded only in HDFs exposed to 500 microM HP for 30 minutes but not in those exposed to undiluted MCN. At this same concentration, HP induced the formation of 8-hydroxy-2'deoxyguanosine adducts in HDFs but this effect was neither observed in control- nor observed in MCN-treated cells. HDFs were further exposed to 5 microM HP or 10% MCN for 1 month. The expression of senescence-associated-beta-galactosidase was only significantly elevated in cells chronically exposed to 5 microM HP. Altogether, these results show that MCN is significantly less cytotoxic than antiseptic HP concentrations (i.e. 880 mM) and that, in vitro, it does not induce genotoxicity or accelerated ageing.

            3. Landa-Solis C, Gonzalez-Espinosa D, Guzman-Soriano B, Snyder M, Reyes-Teran G, Torres K and Gutierrez AA (2005). Microcyn: a novel super-oxidized water with neutral pH and disinfectant activity. J Hosp Infect 61: 291-9. Instituto Nacional de Rehabilitacion, Secretaria de Salud, Mexico, DF. A new super-oxidized water (SOW) product, Microcyn, was tested for in vitro antimicrobial and antiviral activities. The effectiveness of this neutral-pH SOW at killing Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Salmonella typhi and Candida albicans in pure culture was evaluated. One millilitre (approximately 10(8)colony-forming units/mL) of each micro-organism was subjected to 9 mL Microcyn or sterile water at room temperature for 30s. Under these conditions, a log(10) reduction factor of 8 in the level of all pathogens occurred in the treatment samples. In addition, results of tests with three batches of Microcyn exposed to Bacillus atrophaeus spores for 5 min demonstrated complete inactivation of the spores within 2-3 min (log(10) reduction factor >4). The effectiveness of Microcyn in reducing human immunodeficiency virus-1 (HIV-1) on hard surfaces (glass) was also evaluated in compliance with Environmental Protection Agency requirements for virucidal claims. After exposure of the tested surfaces to Microcyn for 5 min without agitation, there was a log(10) reduction factor >3 in the viral load as measured by both cytopathic effect and antigen p24 of HIV-1 production in MT-2 cultures. Microcyn activity against adenoviral vector type 5 was also analysed under simulated laboratory in-use conditions with viral suspensions. In order to increase the sensitivity of the test, the fluorescent light emitted by AdGFP-infected cells was measured with the use of a flow cytometer. A log(10) reduction factor >3 in the viral load was achieved after a 5-min exposure to Microcyn under these strict conditions. These results show that Microcyn exerts a wide antimicrobial spectrum with major advantages over acidic SOWs, including neutral pH, lower free active chlorine (51-85 ppm) and long shelf life (1 year).

            However, having seen the links that you provided, I searched under "dermacyn" and found two randomized controlled trial to asses the efficacy and safety of Dermacyn published this year:

            1. Piaggesi A, Goretti C, Mazzurco S, Tascini C, Leonildi A, Rizzo L, Tedeschi A, Gemignani G, Menichetti F and Del Prato S A randomized controlled trial to examine the efficacy and safety of a new super-oxidized solution for the management of wide postsurgical lesions of the diabetic foot. Int J Low Extrem Wounds 9: 10-5. Department of Endocrinology and Metabolism Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. piaggesi@immr.med.unipi.it. This randomized trial was done to test the effectiveness and safety of using a novel antiseptic solution (Dermacyn(R) Wound Care [DWC], Oculus Innovative Sciences, Petaluma, CA) in the management of the postoperative lesions on the infected diabetic foot. 40 patients with postsurgical lesions wider than 5 cm2 left open to heal by secondary intention were randomized into 2 groups. Group A was locally treated with DWC, whereas group B received povidone iodine as local medication, both in adjunct to systemic antibiotic therapy and surgical debridement if needed. Ischemia, renal failure, bilateral lesions, or immunodepression were considered as exclusion criteria. Patients were followed up weekly for 6 months. The primary endpoint was healing rate at 6 months, while secondary endpoints were healing time, time to achieve negative cultures, duration of antibiotic therapy, number of reinterventions, and adverse events. Healing rates at 6 months were significantly shorter in group A (90%) than in group B (55%; P < .01). The time taken for cultures to become negative and duration of antibiotic therapy were also significantly (P < .05) shorter in group A than in group B, whereas the number of reinterventions was significantly higher in group B (P < .05). No difference was noted in the adverse events except that for reinfections, which were more frequent in group B than in group A (P < .01). DWC is as safe as and more effective than standard local antiseptics in the management of wide postsurgical lesions in the infected diabetic foot.

            2. Mohd AR, Ghani MK, Awang RR, Su Min JO and Dimon MZ Dermacyn irrigation in reducing infection of a median sternotomy wound. Heart Surg Forum 13: E228-32. Heart and Lung Centre, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia. ramzisham@hotmail.com. BACKGROUND: Sternal wound infection is an infrequent yet potentially devastating complication following sternotomy. Among the standard practices used as preventive measures are the use of prophylactic antibiotics and povidone-iodine as an irrigation agent. A new antiseptic agent, Dermacyn super-oxidized water (Oculus Innovative Sciences), has recently been used as a wound-irrigation agent before the closure of sternotomy wounds. METHODS: This prospective, randomized clinical trial was conducted to compare the effectiveness of Dermacyn and povidone-iodine in reducing sternotomy wound infection in patients undergoing coronary artery bypass graft surgery. Upon chest closure and after insertion of sternal wires, wounds were soaked for 15 minutes with either Dermacyn or povidone-iodine. Subcutaneous tissue and skin were then closed routinely. Patients were followed up, and any wound infection was analyzed. RESULTS: Of the 178 patients, 88 patients were in the Dermacyn group, and 90 were in the povidone-iodine group. The mean (+/-SD) age of the patients was 61.1 +/- 7.6 years. The incidence of sternotomy wound infection was 19 cases (10.7%). Five (5.7%) of these cases were from the Dermacyn group, and 14 (15.6%) were from the povidone-iodine group (P = .033). No Dermacyn-related complication was identified. CONCLUSION: We found Dermacyn to be safe and more effective as a wound-irrigation agent than povidone-iodine for preventing sternotomy wound infection.

            In addition, several small clinical series had been reported in 2006 and 2007:

            1. Zahumensky E (2006). [Infections and diabetic foot syndrome in field practice]. Vnitr Lek 52: 411-6. Diabetologicka ordinace, Zlin. zahumensky.emil@seznam.cz. In diabetic foot syndrome, the infection of diabetic ulceration is the critical parameter of classification, the most frequent reason of hospitalization and the main cause of amputations. Debridement and release of pressure are the critical steps of initial therapy of neuropathic ulceration showing no clinical signs of infection. Infection of neuroischemic foot is much more serious condition: in case of positive microbiological finding, antibiotic therapy is recommended even without any clinical signs of infection. Healing can be accelerated by ozone and Dermacyn therapy. Prevention of ulceration should be based on using appropriate shoes (with respect to risk factors) and PC plantography.

            2. Duc Q, Breetveld M, Middelkoop E, Scheper RJ, Ulrich MM and Gibbs S (2007). A cytotoxic analysis of antiseptic medication on skin substitutes and autograft. Br J Dermatol 157: 33-40. Department of Dermatology, VU University Medical Centre, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands. BACKGROUND: There is an increasing demand for the clinical application of human skin substitutes (HSSs) for treating ulcers, burns and surgical wounds. Due to this increasing demand and due to the simultaneous requirement for the administration of topical antiseptic medications, there is a need to determine potential cytotoxic effects of these medications on HSSs compared with autograft skin. OBJECTIVES: To perform such an evaluation. METHODS: Two different HSSs were used (autologous reconstructed epidermis on fibroblast-populated human dermis and allogeneic reconstructed epidermis on a fibroblast-populated rat collagen gel) and were compared with conventional full-thickness autograft. Twelve different antiseptics were applied topically to the stratum corneum in vitro for 24 h. The degree of cytotoxicity was analysed as detrimental changes in histology, metabolic activity (MTT assay) and RNA staining of tissue sections. RESULTS: The antiseptic medications tested showed different degrees of cytotoxicity. Acticoat, Aquacel Ag, Dermacyn, Fucidin, 0.5% silver nitrate solution and chlorhexidine digluconate were not cytotoxic for either HSS or autograft, and can therefore be used as required. Flamazine and zinc oxide cream resulted in moderate cytotoxicity. However, application of Betadine((R)), cerium-silver sulfadiazine cream, silver sulfadiazine cream with 1% acetic acid and Furacine resulted in a substantial decrease in cell viability and a detrimental effect on tissue histology when applied to autograft and especially to HSS. CONCLUSIONS: Due to the potential cytotoxic effect of some antiseptics on HSS, it is advised that clinicians balance the cytotoxicity of the medication, its antiseptic properties and the severity of colonization in choosing which one to apply.

            3. Gonzalez-Espinosa D, Perez-Romano L, Guzman-Soriano B, Arias E, Bongiovanni CM and Gutierrez AA (2007). Effects of pH-neutral, super-oxidised solution on human dermal fibroblasts in vitro. Int Wound J 4: 241-50. Cell Therapy Unit, Instituto Nacional de Rehabilitacion, Mexico City, Mexico. For the past 20 years, super-oxidised solutions (SOSs) have been shown to be potent antimicrobials and disinfectants via oxidative damage. However, the potential toxicity of SOSs on eukaryotic cells has not been documented in vitro. This is relevant because oxygen and chlorine reactive species may possibly induce ageing and irreversible cellular dysfunctions that eventually produce cell death. The present study investigates the cytotoxicity and oxidative stress induced by a novel, pH-neutral SOS (i.e. Microcyn, MCN) on young, primary diploid - human dermal fibroblast (HDF) cultures. For this purpose, hydrogen peroxide (HP) was used as a positive control of oxidative damage. When these solutions were used at concentrations indicated for wound care (i.e. undiluted MCN or 880 mM HP), HP was significantly more toxic than MCN. After 5 and 30 minutes of exposure, cell viability was 38% and 5%, respectively, in 880 mM HP-treated cells versus 75% and 70% in MCN-treated populations, respectively. HP induced both apoptosis and necrosis, whereas MCN induced only necrosis. Genotoxic and ageing studies were then conducted at sublethal HP concentrations as previously reported in the literature. Cellular DNA and RNA were partially degraded only in HDFs exposed to 500 microM HP for 30 minutes but not in those exposed to undiluted MCN. At this same concentration, HP induced the formation of 8-hydroxy-2'deoxyguanosine adducts in HDFs but this effect was neither observed in control- nor observed in MCN-treated cells. HDFs were further exposed to 5 microM HP or 10% MCN for 1 month. The expression of senescence-associated-beta-galactosidase was only significantly elevated in cells chronically exposed to 5 microM HP. Altogether, these results show that MCN is significantly less cytotoxic than antiseptic HP concentrations (i.e. 880 mM) and that, in vitro, it does not induce genotoxicity or accelerated ageing.

            4. Goretti C, Mazzurco S, Nobili LA, Macchiarini S, Tedeschi A, Palumbo F, Scatena A, Rizzo L and Piaggesi A (2007). Clinical outcomes of wide postsurgical lesions in the infected diabetic foot managed with 2 different local treatment regimes compared using a quasi-experimental study design: a preliminary communication. Int J Low Extrem Wounds 6: 22-7. Diabetic Foot Section, Department of Endocrinology and Metabolism, University of Pisa, Pisa, Italy. The safety and efficacy of a novel superoxidized solution (Dermacyn Wound Care [DWC], Oculus Innovative Sciences, Petaluma, Calif) was evaluated for the treatment of wide postsurgical infected ulcers of the diabetic foot. A group (group A, n = 18) of patients with diabetes mellitus who had postsurgical lesions > 5 cm(2) without ischemia or infection were recruited consecutively and treated with DWC-saturated dressings. These dressings were renewed once daily and were compared with a group of patients that had been previously treated with diluted povidone iodine (group B, n = 15) using a quasi-experimental study design. Both sets of patients also received standard systemic antibiotic therapy, as per the practice in this center, and local surgical debridement. Patients had weekly assessments until wounds had re-epithelialized completely. Patients in group A had statistically significant shorter healing time and duration of antibiotic therapy and a higher healing rate at 6 months compared with those in group B (p < .01). Recurrence of infection, requirement for debridement procedures, and requirement for minor amputations were significantly less frequent during follow-up in group A patients (p < .05) when compared with those in group B. These preliminary data suggest that DWC used as a wound dressing together with other local and systemic therapies may have a role in reducing healing time as well as complications in patients with diabetes who have postsurgical lesions of the diabetic foot. These data propose the need for a robust controlled study of DWC-saturated dressings to explore its full potential.

            5. Kaehn K (2007). Dermacyn on the infected foot ulcers of 10 patients. J Wound Care 16: 232.

            6. Steenvoorde P, van Doorn LP, Jacobi CE and Oskam J (2007). An unexpected effect of Dermacyn on infected leg ulcers. J Wound Care 16: 60-1. Rijnland Wound Clinic and Department of Surgery, I Rijnland Hospital, Leiderdorp, The Netherlands. psteenvoorde@zonnet.nl.

            I hope that the company applies to the U.S. FDA for approval of these treatments as a medication rather than simply as antiseptic solutions. In particular, I would be very pleased if there were a well-designed clinical trial showing that dermacyn accelerated healing of decubiti. As we all know, this is a huge and important market with significant unmet medical needs. In my opinion, the company should sponsor a multicenter trial double-blind randomized controlled trial in the U.S. to test the safety and efficacy of Dermacyn on decubiti.

            Wise.
            Last edited by Wise Young; 6 Mar 2011, 9:18 AM.

            Comment


              According to an article in 2009 by Adam Feuerstein entitled, "Oculus Sidesteps FDA rules with wound cleaner", the company "appears to be skirting U.S. drug laws by claiming that its wound cleansing product containing common diluted bleach has drug-like therapeutic properties. The U.S. FDA approved Microcyn as a wound cleaner under the agency's regulation of simple medical devices known as 510(k) approvals but Oculus is marketing Microcyn as a drug with specific medical claims such as eliminating infections, accelerating wound healing, and reducing inflammation in patients with diabetic ulcers."
              Yes, I've come across this before. There are those who feel Adam Feuerstein should be investigated by the SEC. We are now entering the arena of "dirty pool." Here is some info to start with:

              http://seekingalpha.com/article/1464...a-safety-issue

              Susanne
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              Comment


                This goes into it even further, and there are a couple of videos:

                http://biomedreports.com/20090629168...mpany-ceo.html
                I'm back on Facebook again--up and running!

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                Comment


                  I hope that the company applies to the U.S. FDA for approval of these treatments as a medication rather than simply as antiseptic solutions. In particular, I would be very pleased if there were a well-designed clinical trial showing that dermacyn accelerated healing of decubiti. As we all know, this is a huge and important market with significant unmet medical needs. In my opinion, the company should sponsor a multicenter trial double-blind randomized controlled trial in the U.S. to test the safety and efficacy of Dermacyn on decubiti.
                  I want to clear up a little of the confusion here. Oculus Innovative Sciences has already applied to the FDA for full drug status for Microcyn products. This has been pending for some time. Drug applications take far more time to approve than "medical device" applications--it can take years.

                  501k "medical device" status was cleared by Congress for FDA use in 1976. It's purpose was to help bring new and innovative products to market more quickly so the public could reap the benefits, which can be live saving. In recent years the FDA has been more rigorous in giving out 501k clearances because they don't like doing recalls. Despite this, Microcyn technology products have cleared numerous 501k applications with no trouble. This is due to many factors. One is Microcyn's well established "safe as saline" profile. Another is the fact that other countries have already approved Microcyn (Dermacyn) as a drug and many clinical trials have been conducted successfully in these countries--so there's a lot of evidence to present. To date, Oculus can conservatively claim that over 3 million people have been treated worldwide with Microcyn products without a single report of a serious adverse event.

                  The most recent 501k clearance was just last month, for Epicyn, a dermatology product, and it sailed through the FDA with no trouble. So Oculus has this very good track record with FDA.

                  Oculus isn't trying to "skirt around" anything. It is preparing the ground for a remarkable emergence of Microcyn technology in the US, and indeed, the whole world. Drug classification clearance is right on schedule, and will be forthcoming.

                  There are numerous clinical trials in operation as we speak--but I have no specifics on these, because it is not a public matter at this time and Oculus isn't about to spill the beans to me because I have a big mouth--meaning I post everything I hear as soon as I hear it, for the benefit of you all.

                  There is going to be much more recognition of the role oxychlorine compounds can play in medicine in the coming decade, especially because we are moving rapidly into what is being described as the "post-antibiotic world."
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                  Comment


                    Originally posted by Leila View Post
                    I want to clear up a little of the confusion here. Oculus Innovative Sciences has already applied to the FDA for full drug status for Microcyn products. This has been pending for some time. Drug applications take far more time to approve than "medical device" applications--it can take years.

                    501k "medical device" status was cleared by Congress for FDA use in 1976. It's purpose was to help bring new and innovative products to market more quickly so the public could reap the benefits, which can be live saving. In recent years the FDA has been more rigorous in giving out 501k clearances because they don't like doing recalls. Despite this, Microcyn technology products have cleared numerous 501k applications with no trouble. This is due to many factors. One is Microcyn's well established "safe as saline" profile. Another is the fact that other countries have already approved Microcyn (Dermacyn) as a drug and many clinical trials have been conducted successfully in these countries--so there's a lot of evidence to present. To date, Oculus can conservatively claim that over 3 million people have been treated worldwide with Microcyn products without a single report of a serious adverse event.

                    The most recent 501k clearance was just last month, for Epicyn, a dermatology product, and it sailed through the FDA with no trouble. So Oculus has this very good track record with FDA.

                    Oculus isn't trying to "skirt around" anything. It is preparing the ground for a remarkable emergence of Microcyn technology in the US, and indeed, the whole world. Drug classification clearance is right on schedule, and will be forthcoming.

                    There are numerous clinical trials in operation as we speak--but I have no specifics on these, because it is not a public matter at this time and Oculus isn't about to spill the beans to me because I have a big mouth--meaning I post everything I hear as soon as I hear it, for the benefit of you all.

                    There is going to be much more recognition of the role oxychlorine compounds can play in medicine in the coming decade, especially because we are moving rapidly into what is being described as the "post-antibiotic world."
                    Leila,

                    The company should become more transparent, announce their clinical trials, and refrain from claiming that the treatment is effective for conditions for which it has not yet been approved. If Oculus has clinical trials underway, it should announce them on http://ClinicalTrials.Gov, as most companies do.

                    Such announcements would help boost their stock. The FDA has been coming down hard on companies that advertise claims beyond the approved indications and labels. The videos on the company's web site, for example, are claiming efficacy for conditions for which the products have not yet been approved.

                    If the treatment is effective, the company has a great deal to gain. They should not take these risks.

                    Wise.

                    Comment


                      Thank you, Wise for all the work that you posted. I don't think that any of the moderators are ignoring the posts. I really appreciate it and I am sure that the other nurses do also.
                      CKF
                      The SCI-Nurses are advanced practice nurses specializing in SCI/D care. They are available to answer questions, provide education, and make suggestions which you should always discuss with your physician/primary health care provider before implementing. Medical diagnosis is not provided, nor do the SCI-Nurses provide nursing or medical care through their responses on the CareCure forums.

                      Comment


                        I neglected to search clinicaltrials.gov when I made my last post. I just did a search and found that Oculus did announced a trial to study dermacyn effects on diabetic foot ulcers on Clinicaltrials.gov.

                        http://clinicaltrials.gov/ct2/show/N...ermacyn&rank=1

                        Comment


                          The company should become more transparent, announce their clinical trials, and refrain from claiming that the treatment is effective for conditions for which it has not yet been approved.
                          I'm afraid I am not defining clinical trials in the same way you are referring to here. There are many classifications, on all levels. The kind of trials you are referring to can cost up to a quarter of a billion dollars. We will probably not be seeing these kinds of undertakings until the company achieves a certain level of profitability. At this point, they are as transparent as they are required to be.

                          They are not claiming things that have not been approved--not in the least. There is no proof whatsoever of this. There are a great many doctors and patients making such claims, and rightly so. Lives have been saved in the most dramatic ways. But Oculus is not stupid--they know exactly what they can claim and what they cannot claim. They are extremely careful. They do enjoy putting forth anecdotal testimonials, but they make it clear that this is not the kind of claim that violates any FDA requirements.

                          The videos on the company's web site, for example, are claiming efficacy for conditions for which the products have not yet been approved.
                          You need to understand that the company's website is of a global nature. If you go to the site index, it will designate various countries. The videos from Mexico, Italy, and other countries, show work that has been done under other regulatory conditions. Videos showing exploratory work being done in the US make no claim to be other than that--exploratory work with really great results.

                          It will all come together in time. The only problem is, many people don't have time. They are dying of infections that are resistant to abx and have no options. This is happening with increasing frequency. So advocates such as myself do everything in our power to increase awareness so that lives can be saved. Oculus has no control over what we do as advocates, and no responsibility--we are free agents and work with people on the grassroots level.

                          In truth, Oculus has very little to do with me. I'd like to think perhaps they in some ways admire what I do, but they have never condoned my work. I don't work for them and own no stock in their company. I am treated like any other member of the public when I ask questions of them. .

                          I am not ungrateful to you Dr. Young--I think your forum is one of the best in the world and has helped a great many people. I admire you for that, and for your distinguished career as a scientist. I'm sorry that you have adopted such a doubting stance toward this company. Perhaps if one of your loved ones life had been saved when there was no other hope, as was the case with me, you would feel differently. I guess that's the difference between us--I am dealing with it from my heart.
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                            Thought I'd give a little update here. I am the mom of a little girl incontinent due to spina bifida. She was in the middle of a 2-month long bout of cloudy urine with no other symptoms when I came across this thread. We managed to clear up the cloudy urine with a little baking soda water for a few days. No, it is not recommended for chidren, but having a child with SB we use a lot of things normally not recommended of children. And let me say that I monitored her throughout the three days of this, and gave it to her in low dose throughout the day, not all at once. Miralax is another one we use regularly, it says right on the bottle not to be used by children our daughter's age, but her doctor recommended it, and when it comes to preventing plugging the colon, a very serious problem for SB kids, it has worked wonders.

                            Anyway, we have been using the vetericyn as a liquid to store her re-useable catheter in. Since her catheter is made of silicone it is actually slipery when wet and we don't need to use a lubricant, so we take the catheter right out of the solution and insert into the urethra. She gets a little vetericyn treatment from the catheter at every insert. We have also been spraying it on the urethral opening before inserting the catheter. It has been a few weeks and she has had totally clear urine since, except for a couple of bouts of sediment at the end of urination, probably from us waiting too long between caths. Its my understanding that sediment is not infection, so I'm thinking we are all clear!

                            I know some of you have said that it would be more effective if I do the actual injections, and I would if she had any symptoms of pain or discomfort or fever, but we have always been symptom free. I don't think the injections are warranted for us at this time. I like that there are the good bugs living in her bladder, and hope she builds up better immunity to the bad bugs, which she wouldn't be able to do if we disinfected her bladder all the time. I don't know what the results would be if we constantly cleaned out everything over years of time. Will the bad bacteria take over with a vengence if she ever decides to stop, or if Oculus goes out of business? For now I think it would be better to let her try to build up some immunity to the bugs. Give her body a chance to do what it does naturally and give her natural imune system all we can. I will say, however, that I am exceptionally excited to have found this thread and see how well the Vet is working for us in the capacity in which we use it.

                            Even though our version of the Vetericyn treatment has been great, I totally get what Dr. Young is saying, and thank him for his logical and professional input. Its one thing for a person to say "works for me", its totally another for a professional to endorse something. I'm a scientist that oversees groundwater sampling and groundwater clean-up methods at a government agency, and I know first hand how important real peer-reviewed scientific study is! Hopefully Oculus will get the money it needs to do some of these.

                            Kelly

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                              I'm so glad your little girl is feeling better Kelly. Mother knows best!
                              I'm back on Facebook again--up and running!

                              http://www.facebook.com/profile.php?...00000532232573

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                                Originally posted by Leila View Post
                                And what about Christopher Reeve? A very reputable RN told me that he had been experiencing a recurring decubitis ulcer that went septic. His doctor gave him an injection of a powerful IV antibiotic, he went into anaphylactic shock, and died. If that doctor had known about the impressive success wound care clinicians have achieved using MIcrocyn technology to heal these sores, one of the best SCI advocates on the planet would still be alive.
                                you've got to be kidding me! now you're not just preaching anecdotal evidence as scientific fact, you're claiming christopher reeve would still be alive if only he'd had access to microcyn?

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