Why doesn’t Care-Tech® use alcohol in Techni-Care®? All other pre-op preps and surgical scrubs contain alcohol.
Care-Tech® Antiseptic technology is designed to be non-toxic and with significant therapeutic benefit of use. These objectives have never been achieved in prior chemistry.
Linear alcohols are somewhat of a fallacy in antimicrobial or bactericidal action, as the effects can be calculated in seconds. There simply is no capacity to provide any sustained benefit, which we view as mandatory for surgical scrub and preoperative prep functions.
Alcohol is destructive to dermal cells, as it robs the tissue of moisture. Robbing the tissue of moisture creates cracking and severe dryness of the dermis, and thereby actually produces a breeding ground for bacteria. Linear Alcohols have a number of other toxicity issues and are not broad-spectrum in bactericidal action.
Alcohol as a proposed raw material simply does not meet Care-Tech® criteria for cellular compatibility, nor does it have any therapeutic benefit. Alcohol is an inexpensive material, which does not require any formulation expertise, and therefore is not even considered or classified as a pharmaceutical substance.
Can Techni-Care® be used as a prep or is it just a surgical scrub?
Techni-Care® was developed for pre-operative, microbicidal scrub and prep procedures and post-operative dermal wound cleansing and decontamination. Techni-Care® is now widely used for treatment of topical infection in cuts, scratches, and topical wounds.
Is Techni-Care® safe for usage on mucous membranes?
Yes. Techni-Care® is safe for usage as a vaginal prep and around eyes, ears, and facial areas. It is the only microbicide which can be used safely on mucous membranes. It contains no linear alcohol which defat the tissue.
Has Techni-Care® been tested on mucous membranes?
Techni-Care® has undergone the latest technology in the testing of a topical degerming preparation entitled the Eyetex Screen. The Eyetex Screen is a computer simulation of the membranes in the human eye. Eye membranes are the standard for the most sensitive mucosal membranes in human beings. The Eyetex Screen is a relative of the historical Draize testing of irritation and the "Occular Irritation in Rabbits Standard. Techni-Care® received a test rating of minimal to mild in ocular irritation or in raw score a number less than shampoo. For a very powerful antiseptic product, these test results are phenomenal. Other microbicidal product manufacturers have been unwilling to release this type of test data to the end-user on their products. There are a number of hospitals which currently utilize Techni-Care® in their OB departments at this time so references are available for vaginal prep end-users.
How does Techni-Care® compare to other branded products such as Betadine (Povidone Iodine) or Hibiclens (CHG)?
In reality, all three products are effective degerming solutions. It would not be fair to compare Techni-Care® directly to these prior types of technologies as Techni-Care® is approximately fifty years further advanced in formulation technology and tissue synergy. Both Povidone Iodine and CHG solutions are basic blends of alcohol, low grade detergent in minor quantities and an active ingredient. Techni-Care® is a cationic blend of surfactants, emollients, two active ingredients: PCMX, which is a substituted or man-made phenolic, and CocamidopropyI PG-Dimonium Chloride Phosphate, which is a quaternary compound as well as a phospholipid, collagen, aloe, and a humectant. Povidone Iodine is also inactivated by blood and other organic materials. Techni-Care® remains active. CHG is a highly unstable molecular structure with a lengthy list of materials which reduce efficacy.
How does Techni-Care® compare in toxicity testing to prior technology in surgical degerming solutions?
Techni-Care® is the first nontoxic microbicide in the history of Chemistry. Povidone Iodine and CHG are toxic substances by oral toxicity ratings.
A 30-second kill rate is much faster than the prior 5 to 7 minutes which we were taught in medical or nursing schools. How can this product kill microorganisms at this speed?
The combination of the substituted phenolic combined with the quat achieves a 60,000 parts per million level of antimicrobial power. No other dermal substance utilizes the power of a quat and a substituted phenolic in one synergistic formulation. Some of the most difficult organisms to kill topically are vegetative bacteria which require 2,000 to 3,000 parts per million. Techni-Care® is formulated at such a level of over kill that it basically annihilates all organisms in which it comes into contact. Its surfactant base is also much more efficient at removing oil and organic materials which allows the actives to work more rapidly.
Why doesn't Povidone Iodine or CHG kill organisms as fast as Techni-Care?
Much of the answer to that question lies in the lack of formulation synergy in prior technology. The molecular structures of both CHG and Povidone Iodine are extremely large and with very heavy molecular weights. Techni-Care's molecular size and weight are a number of times smaller and are much more efficient in chemical action and in the ability to kill on contact. We would suggest a quick review of molecular differences which are easily obtainable in The Merck Manual or in basic chemistry books on disinfectancy. Techni-Care® is cationic and bonds to tissue much like a magnet. It is also transdermal and will penetrate to the blood stream.
Given the molecular size of Povidone Iodine and CHG, it is virtually a chemical impossibility to achieve rates of efficacy faster than 5 to 7 minutes. Both PVP and CHG, molecules require a reaction time to, let's say, detonate the antimicrobial efficacy. All three are very different in their method of killing microorganisms. CHG and PVP would have to undergo new molecular restructuring to achieve the type of kill ratio’s which Techni-Care® achieves. Again, Povidone Iodine is inactivated or denatured by organic materials including blood.
Are there differences between branded Hibiclens or Betadine products versus the generic labels which are lower in price?
No. All product formulations are basically the same. In reality, there is only one chemical manufacturer of CHG in the United States and the raw material is licensed to various companies which blend the alcohol and detergent into a product under their own label.
We have experienced a faster rate of wound or incision healing with usage of Techni-Care®. Why does this occur?
The exotic phospholipid utilized in Techni-Care® works "in synergy" with the natural lipids in the epidermis. We have seen unbelievable skin healing results and were quite amazed ourselves at this phenomena. Techni-Care® is the first skin care product in which we have utilized phospholipid technology. It has been used in European products for a number of years. We will continue to expand on this technology in future product development.
How does Techni-Care® compare in price to Betadine and Hibiclens?
The pricing is currently very competitive with prior technology in degerming solutions when one evaluates only from the cost of a bottle. The cost per usage is significantly lower than Betadine and/or Hibiclens. Techni-Care® is an extremely high viscosity solution while Povidone Iodine and Hibiclens have a viscosity equal to water. There is a substantial amount of product loss with both of these substances. In addition, Techni-Care® requires no dilution time, labor, nor supplies. The same formulation can be utilized for all microbicidal functions which substantially cuts down on the number of product types and containers carried in inventory. Techni-Care® also eliminates the problem of "pooling" (chemical burns) in lengthy surgical procedures.
Does Techni-Care® stain linens, equipment, or skin?
No. Techni-Care® leaves no stain and rinses off easily with water. The non-staining benefit of usage is another area of cost savings. We have viewed a number of operating room suites with relatively new equipment already damaged with unsightly brown stains. Povidone Iodine stains immediately while CHG reacts chemically with bleach in the wash cycle on linens, uniforms, etc., also producing permanent brown stains.
I have heard that under F.D.A. regulations PCMX is rated in a category #3 which means it is not effective. Is that true?
F.D.A. did classify topical antimicrobials under three specific categories in their tentative monograph. These three categories include topical safety and systemic safety in combination with efficacy classifications. Their definitions are as follows:
Category I - Safe
PCMX was classified in Category III originally upon its introduction in the U.S. from Europe. At the date of last review for topical, antimicrobials which was January 6, 1978, the "Tentative Monograph" was published but has to date never been finalized and is still in a pending mode. PCMX was placed in Category III along with Povidone Iodine due to lack of systemic studies. CHG was classified in Category II and then reclassified as a prescription drug due to its toxicity level and contraindications. In 1978, we also did not have the technology in testing equipment that is in existence today. No Care-Tech® product information was included in this panel review and Techni-Care® had not yet been developed.We look forward to the next product review date as we feel we have a history of superior quality, safety, and unprecedented antimicrobial activity. Our documents are in order and waiting. The problem is that this review has yet to be scheduled and the monograph has never been finalized.
Is Techni-Care® available from any other company?
No. Techni-Care® is a proprietary product manufactured only by Care-Tech® and available only through authorized Care-Tech® distributors. It is a new U.S. patent with many years to go!
Why doesn't Techni-Care® attack human cells as it does bacteria, yeast and fungus?
Species specific toxicity. Although this antimicrobial is highly efficacious on a broad spectrum of microbes it has no toxic effect in vivo to human tissue. Due to the synergistic blend of phospholipids, Techni-Care® actually enhances wound healing in actual clinical situations Techni-Care® attacks and destroys the cell wall in a cell lycing capacity of single walled organisms.
We are currently using Dura-Prep from 3-M because our surgical drapes stick better. Will Techni-Care® adhere to drapes like Dura-Prep?
No, the Dura-prep solution in the plastic applicator contains a polymer adhesive in linear alcohol. We would not condone the use of polymers which could be introduced into the blood stream with a surgical incision. Linear alcohols as a surgical prep option also have no substantivity or ability to retain microbicidal action. Techni-Care® is cationic and bonds naturally to the tissue as well as providing transdermal, antimicrobial action for periods of hours without the addition of any glue-like substances which may flake and contaminate open wounds. A research project we hope to pursue in the future is the clarification of the actual need for drapes. Originally they were developed as a physical barrier against microbial invasion. It may be possible to coat a patient with a cationic bonding solution such as Techni-Care® and eliminate the need for a physical drape device. They seem to be somewhat prehistoric and we believe there may be better technological innovations at far less cost with a non-toxic chemical barrier.
We have used Techni-Care® in wound cleaning for a lengthy period of time and find some wounds turn a yellowish or greenish tint. No signs of infection occur and no pain or tenderness is reported by the patients. Why does the wound discolor in this manner?
We have had numerous reports of this discoloration occurring in chronic wounds and with no apparent negative effects. Healing continues and healthy tissue appears to fill in. This does not appear to be a negative side effect of using Techni-Care®. We suggest rinsing / irrigating the wound bed with Clinical Care® solution after the cleansing and decontamination step with Techni-Care®. We believe this discoloration is caused by a build-up of surfactant residue which can be eliminated by proper rinse / irrigation protocols. The discoloration does not appear to be harmful nor have we had any reports of damage to normal cellular regeneration.
We have reviewed an article by a Dr. George Rodeheaver who claims Techni-Care® is toxic and must be diluted 1:100,000. I have been using Techni-Care® for years in my plastic surgery practice and have never had any problems. Should I discontinue using it or try to dilute the product?
Techni-Care® has been proven to be a non-toxic microbicide by all F.D.A. approved testing methods as well as those testing protocols as approved by the National Association of Chemists. These testing guidelines are mandatory and include ocular irritation testing as well as oral toxicity / ingestion testing. All product testing on Techni-Care® is available upon request by end-user facilities.
The article by Dr. Rodeheaver is interesting to say the least. This was not published in a peer reviewed medical journal nor does his study have any basis in bio-chemistry or scientific fact. Dr. Rodeheaver is not a medical doctor nor could we find any educational credentials attributed to his name in the fields of bio-chemistry, microbiology, physiology, chemistry or even nursing. We do find his name as the patent holder on a cosmetic solution named "Shur Clens" which he highlights in his article. This article was not an I.R.B. clinical nor does it meet duplication specifications and basic statistical guidelines for a masters thesis.
The following is an in-depth analysis of the article accomplished by our in-house staff biologist. The author of this review has an undergraduate degree in Biology from Washington University in St. Louis so this analysis has been accomplished by a minimal level of education in Care-Tech's field of biochemistry.
It is well known and documented in chemistry and cellular biology that antimicrobials and surfactants work by their production of free radicals as do phagocytes, to lyse invading bacteria. It is also a well known fact that an enzyme, gluthaione peroxidase, act as a constant detoxification system for the free radicals thus produced. Thereby preventing the self destruction of the leukocyte. It is also well known that the activity of polymorphonuclear leukocytes (PMNs) slows down dramatically when the more efficient antimicrobials are present - in essence, they are sitting on the bench while the first string play the game. Therefore, the PMNs increase production activity only after or if the antimicrobials are not effective or not present to protect the wound or if the wound is being incompetently managed. Phagocytes are only reactive when needed and life is threatened by foreign invaders (bacteria).
To prevent infection in wounds, the oxygen normally supplied by cellular respiration and macrophage generation is adequate for normal phagocytic activity to control the high titer of bacteria which may overwhelm the defense. In true clinical situations, untreated wounds contain high levels of real toxins produced and liberated, not by antimicrobials, but by bacteria which may present life threatening toxic shock. In real toxicity / septicemia, if allowed to progress will produce overwhelming infection and death.
Note: Ignorance is an expensive teacher and unfortunately sometimes human life is the price paid. We should not allow ourselves to regress to the dark ages prior to Lister and others nearly a century past. In reality what Dr. Rodeheaver is advocating is non-therapeutic treatment for chronic, infected wounds. Cosmetics, soap and water, nor saline solution have ever demonstrated any type of healing or therapeutic capacity in documented clinical history.
Care-Tech® is continuing full research and development activities in the development of non-toxic, antimicrobials for the treatment of topical infection as well as prevention. At no time could we scientifically justify withholding proper technology to save a human life or limb for a hypothetical slowdown in wound healing.
Can you address the new guidelines suggesting we use alcohol for scrub procedures prior to invasive proceduresas published by the C.D.C. in 2002/2003?
The guidelines as published are very vague and unusually lacking in scientific support. They do suggest washing with soap(surfactants) and water initially, and follow-up with alcohol gels/formulations and then hand lotion to treat the skin breakdown induced by the alcohol.
Care-Tech® does not formulate any dermatological treatment product utilizing linear alcohols. We do utilize linear alcohols in a few of our hard surface disinfectants. Alcohol defats the tissue causing cellular destruction or severe damage. An end-user will observe this phenomena by experiencing dry, cracked, reddened, irritated hands. This environment then creates fissures, lack of turgor and skin suppleness which provides an excellent breeding ground for bacterial invasion.
Linear alcohol combinations including povidone iodine/alcohol, CHG/alcohol, alcohol with emollients, etc. have always been utilized in the U.S. market with the same basic negative effects and tissue trauma. The negatives outweigh the positives and we then observe lack of compliance to any hand washing protocol due to painful outcomes of the end-users.
In addition to the physiological effects to the dermis, we then encounter fire/explosion effects, inhalation problems and occular irritation factors.
From a pharmaceutical formulation viewpoint these alcohols are "no-brainer formulations" which require no specific expertise nor intent to safeguard individuals who are required to comply with consistent infection control policy. They are extremely cheap to produce but we do not believe cost is the only factor which should be considered in developing chemical technology for long-term use on humans.
We like Techni-Care® as a scrub, but our surgeons won't use it for prepping because they can't see it on the skin very well. Can you put some iodine in Techni-Care® so we can use it as a paint?
No. We are not interested in utilizing iodine in Techni-Care®. The product currently is not a dermal irritant and the addition of iodine would be a skin irritant as well as causing allergic reactions. Iodine also reacts with starch or the cornstarch powder utilized as a lubricant in latex gloves. Povidone Iodine is inactivated by organic materials including blood. We have a formulation of Techni-Care® which contains Bright "phosphorescent yellow" food grade dye, available in a 4oz. size bottle. It rinses off easily with water and is safe and non-toxic. It also can be readily seen on Black and Hispanic skin colorations.
Why did Care-Tech® Laboratories develop a product like Techni-Care?
We knew that we owned extensive knowledge and experience in the development of topical antimicrobial product formulations which eliminate microorganisms without being a causative factor in dermal breakdown. That combination is quite unique to Care-Tech® products. Many truly effective antimicrobial solutions are extremely detrimental to human skin. We studied scrub and prepping solutions as well as the acceleration or increase in surgical site infections and decided that what was being used simply did not work!Topical antibiotics do not perform at the level of efficacy in treatment of topical infection that Care-Tech® antimicrobials exhibit and have extensive contraindications and/or side effects. Utilization of systematic antibiotics to circumvent the lack of appropriate or effective antimicrobial products also seemed an extremely expensive methodology to counteract surgical infection. In addition antibiotic technology is failing and we were determined in pursuing replacement topical technology.We were committed to developing a product which would be non-staining, soothing, and gentle to the dermal tissue as well as a powerful microbicidal agent. We believe we have achieved our objective in the development of Techni-Care®.
Is Care-Tech® stock available for purchase?
(This is the number one question which we get through our customer service departments from surgeons all across the United States.) No. Care-Tech® is a 107-year old, privately held, third generation, family owned corporation. Our commitment will continue to be in developing .premium quality, antimicrobial technology for the healthcare industry. We do not intend to dilute our focus on product research and development.
Techni-Care® in the 4 oz. prep size comes with "extra dye" for ease of surgical determination of proper prep procedures. Can I use this 4 oz. with extra dye for wound cleansing and decontamination?
The 4-ounce container with additional dye is still non-toxic but dye in itself is a dermal irritant as well as a tissue irritant. We recommend you use only the Techni-Care® product sizes without additional dye levels to avoid any unnecessary allergic reactions. At this point we have had zero allergic reactions reported from Techni-Care when used accordingly to labeled instructions in wound cleansing. That figure represents 7 years of Techni-Care use in wound care.
How did this advertisement by Dr. George Rodeheaver come to be published in a H.C.F.A. Wound Care Guideline document?
We have no idea! We'd make a wild guess at money and politics! We did report and file a protest with the proper personnel at F.D.A. Their response was even more frustrating as the F.D.A. department who is responsible for review had never seen the article nor approved it for publication.
From a basic common sense standpoint we know of no substance compared to any other substance which is in the realm of 100,000x greater than. (Acid is not 100,000x greater than water in its toxicity.) There is no such realistic dilution factor as 100,000x.
Valid research compares "like things to like things." We would call a document comparing Tide® to Techni-Care® as invalid. Compareing pharmaceuticals to cosmetics or soap/water is simply not valid. Dr. Rodeheaver also threw Hibiclens® into his chart which is contra indicated by the manufacturer for use in open wounds or mucosa. (See MSD on Hibiclens®) Manufacturers label claims and indications must be accurately followed in any valid assesment or research conducted by intended use.
(Note: Please research who funded this article. That information is given at the end of the article.)
Why do you think Techni-Care® will lower the current rate of post-operative surgical site infection?
We are tracking end-user facilities on computer databases and staying in very close contact with end-users. We have documented zero rates of infection in those facilities which utilize Techni-Care® in all three capacities: as the pre-operative solution, as the scrub solution in operating room environments, and inpatient care of the surgical site, or post-operative site maintenance.
Can Techni-Care® be used for general handwashing protocol for hospital personnel?
Absolutely -- Although Care-Tech® produces antimicrobial handwashing solutions which are just as effective in efficacy without the massive overkill or the extent of active ingredients which Techni-Care® contains. F.D.A./C.D.C. guidelines require a product utilized in a surgical setting to have a minimum of 3% active ingredient in the formulation. Care-Tech® produces CC-500®, Loving Lather II®, and Satin® at a 0.8% active level or 8,000 parts per million in antimicrobial action. These products are much lower in price, also contain emollients, and still provide more than necessary proven microbicidal action and are excellent for patient care bathing to break the chain of cross-contamination.
I have read a number of articles which suggest that PCMX or Chloroxylenol has not been proven to be an effective antimicrobial agent. Why is Techni-Care® different?
The answer to that question had us frustrated for many, many years. Care-Tech® has been formulating topical antimicrobials utilizing PCMX(USP grade) for over thirty years. Our antimicrobial product testing or evaluations of efficacy clearly speak for themselves. We have never formulated a product utilizing this active which has tested lower than 95% in antimicrobial action.
For many years, we had no idea what competitive companies were doing incorrectly to negate the efficacy of PCMX. Then approximately three years ago, when we had just released Techni-Care to the U.S. market, a salesman from one of the chemical companies was in conversation with the biochemist who formulated Techni-Care® and noticed a bottle on his desk. The salesman was absolutely astounded that Care-Tech® had formulated their own PCMX based surgical scrub and informed us that "everybody" who utilized PCMX bought his company's "pre-mix" for their products. So we had our first clue as to what the basic problem might be. We, of course, suggested that we would review this "pre-mix" solution for possible purchase by Care-Tech®. A sample was gladly Federal Expressed to our research department the next day. The "pre-mix" itself was formulated in a 100% degree opposite manner than the formulations developed in-house over the years by Care-Tech®. We very rapidly had our answer to this puzzling dilemma in an 8-hour review of the substance.
At this time, we are not willing to release the particular reason for the defect in this pre-mix. Care-Tech® formulations are proprietary and our products' test data which has been accomplished by non-biased outside scientific laboratories again clearly speaks for itself in comparison. PCMX is an extremely difficult ingredient to suspend in solution and requires a high degree of expertise in formulations. The raw material itself is a crystalline powder which is not water soluble, nor is it active in the crystalline powder form. There is a very simplistic methodology of solubilizing this ingredient which requires no formulation aptitude and was the manner in which the "pre-mix" was produced. The chemical which is utilized to solubilize the PCMX in this procedure clearly negates the antimicrobial capacity of PCMX.
We obtained the list of products produced in the U.S. market which includes this "pre-mix" and find that the sales representative was entirely correct. It did include most other products which utilize PCMX in formulation.We can also further explain that PCMX is totally formulation dependent unlike CHG and Povidone Iodine. The primary goal in developing products which utilize PCMX must be in achieving synergy with other ingredients as well as the dermal tissue. End-users must ask to see individual test data on any PCMX product under evaluation as there are substantial variations in efficacy given raw materials utilized.
Care-Tech® is the only U.S. manufacturer which produces PCMX based antimicrobials under extreme heat conditions. Techni-Care® is still a very difficult product to produce and is very expensive to manufacture given the extent of the raw material combination. Our objectives now lie in increasing our skills in order to enable us to produce Techni-Care® at a more rapid pace.
Is Techni-Care® supposed to be mixed with water or diluted before prepping the patient's skin?
No. Techni-Care®'s molecular structure is perfect in its packaged form and does not require the addition of water to activate the antimicrobial action. The addition of water actually upsets the product's molecular balance and can cause a salting out effect of the active ingredients.
Does Techni-Care® need to be wiped off after prepping prior to invasive procedures?
No. The product should be swabbed on and allowed to air dry. If the patient is still wet and the surgeon feels uncomfortable, then the site can be blotted with a sterile 4x4 to remove excess Techni-Care® from the site. Remember that this product is Non-Toxic!
What is the regulatory status of Techni-Care®?
TECHNI-CARE® was registered in 1991 under the "Topical Antimicrobial Monograph" under F.D.A. Today, this monograph has been updated and renamed "Topical Antiseptics" and is listed in the Anti-Infectives category.
The F.D.A. Monograph governs the chemistry and outlines the required procedures for labeling, usage, and product testing of all over-the-counter topical drugs. Since, Techni-Care® is a product that complies with all aspects of the F.D.A. Monograph, it was not required to go through a separate approval process that is required for products who do not comply with the F.D.A. Monograph. Therefore, Techni-Care® is considered to be a product registered under the F.D.A. guidelines and did not require an additional "Approval" process.
Chemicals that are unknown, which have toxicity issues, or do not have a long history of use in the United States Pharmacopoeia or European Pharmacopoeia, have a different regulatory and registration process. Products that contain these chemicals would be unacceptable under the Over-The-Counter F.D.A. Monograph due to a lack of history showing safety and efficacy.