Science of Rolacol®
This white paper is intended to educate regarding Rolacol®, it is not intended to diagnose, treat, cure or prevent any disease. Rolacol® is for personal use only.
The practice of swabbing skin with alcohol for an injection is a long held preparation by healthcare professionals and patients alike. Today one can’t receive a flu shot from your local pharmacy without being swabbed, or blood drawn by a phlebotomist without getting swabbed. But is it necessary? Like just about any question it depends on who you ask or what study you read.
One study with 5,000 participants that didn’t swab for insulin injections experienced no skin site issues. The study’s logic was that large amounts of a specific bacteria first need to colonize on skin before clinical infection can develop. That’s true there is no such thing as instantly getting an infection. However, the potential effects of bacteria entering the bloodstream was not considered in the study.
Then there is a study where researchers recommend cleaning the injection site in order to minimize the potential ‘risk’ of infection from injections. The research logic was, if there is a chance of infection or bacteria entering the bloodstream why chance it. And that, it was a good practice to maintain a healthy, clean skin routine.
Purpose of Cleaning
What is absolute, bacteria, viruses and fungi are present on skin at any given time. While they may not cause a problem sitting on the surface of the skin as one study points out, the reality is blood from an insulin injection is not commonly present, but blood from a finger prick is
and therein lay the potential problem.
The facts are those with diabetes have two common events, high blood sugar levels and most often than not an immunodeficiency. (white blood cells do not function well when blood sugar level is high). Although a bit more complicated, bacteria thrive on [sugar] and the immune system works to kill that bacteria. But high levels of one and the latter in question offer the potential for a perfect storm.
Sure, regular glucose testing, and for some injecting, is a pain to deal with, prepping skin just adds to the inconvenience and time of it all. But adding cleaning to the routine just may eliminate – albeit slight – problems. Moreover, there is a relief aspect to it, one less thing to worry about in the management of your diabetes.
Now for the Science
As all know most bacteria living in and on our bodies are good and serve a purpose. These microbes typically live alongside many other species in complex communities and can determine our health and well-being. Skin flora (skin microbiota) refers to microorganisms which reside on the skin.
Many bacteria of which there are around 1,000 species on human skin are found mostly in the superficial layers of the epidermis and the upper parts of hair follicles. Skin flora is usually non-pathogenic, and either commensal (are not harmful) or mutualistic (offer a benefit). The benefits bacteria can offer include preventing transient pathogenic organisms from colonizing the skin surface, either by competing for nutrients, secreting chemicals against them, or stimulating the skin’s immune system. However, a few resident microbes can cause skin diseases and enter the bloodstream creating life-threatening diseases, particularly in immunosuppressed people such as those with diabetes. Then there is bacterium E. coli and Saccharomyces cerevisiae used to produce insulin.
The question becomes which are detrimental bacteria, particularly to those with diabetes who are prone to infection?
They range in severity from mild to life-threatening. The majority of skin infections are caused by two types of bacteria: Staphylococcus aureus or a variant of Streptococcus (same bacteria responsible for strep throat), deadly if enters the bloodstream. Gram-positive bacteria, such as Staphylococcus aureus and beta-hemolytic Streptococci, are the most common pathogens in previously untreated mild and moderate infection.
Staphylococcus aureus is present in the nose (usually temporarily) of about 30% of healthy adults, on skin about 20% of people. Percentages are higher for people who are patients in a hospital or who work there. If having entered the bloodstream Staphylococcus aureus can spread to bone from infection or from infection in adjacent soft tissue, as may occur with deep pressure sores or foot/toe sores related to diabetes. A person can carry the bacteria without having any symptoms.
Obviously, bacteria spreads person to person by direct contact or through contaminated objects like gym equipment, telephones, door knobs, television remote controls, elevator buttons – pretty much all hard surfaces.
According to the U.S. Centers for Disease Control (CDC) most bacteria such as Staphylococcus aureus can be rendered ineffective by washing hands. Washing displaces the bacteria but doesn’t kill them merely flushes down a sink drain. In absence of soap and water the CDC suggests a hand-sanitizer with the main ingredient being isopropyl alcohol (aka rubbing alcohol), of at least 65% also used in alcohol swabs. Clearly a convenience over the lack of soap and water but even swab use can be inconvenient. Either method are excellent solutions, however, like washing hands swabs are a temporary solution, in no time bacteria will be reacquired through daily activities. One leading swab manufacturer suggests washing hands before using their swab product. A bit much that likely contributes to an already inconvenient process leading to non-compliance entirely.
Isopropyl alcohol, while wet, will kill most all bacteria on contact, approximately 82%, but, if the alcohol hasn’t evaporated completely any ‘wetness’ could dilute blood causing a false meter reading. And, isopropyl alcohol dries skin, for that reason the American Diabetes Association (ADA) recommends not to use swabs. Dried skin can contribute to skin bruising and added pain.
So what is the point of either solution if bacteria is temporary displaced?
Glucose testing (glucose check), as those with diabetes know all too well, a finger is pricked, blood is drawn and applied to a test strip. One of the marvels of blood it immediately begins to clot to stop the bleeding. Depending on the size of the blood producing puncture it will scab over. Therein lay one of the problems. Bacteria surrounding the area can immediately spread under the clot (scab) which can cause infection or worse directly enter the bloodstream. For that same reason foot/toe wounds are so destructive, bacteria forms under the clotting (scab), infection occurs due to poor circulation (Diabetic neuropathy) making healing a challenge.
People with diabetes are more susceptible to developing infections, as high blood sugar levels can weaken the immune system defenses for fighting ‘bad’ bacteria, and reduced blood flow to the extremities, fingers for example, increasing the body’s vulnerability to infection.
For reasons outlined, regardless of the method used for cleaning skin it is a good habit to do so every time you check glucose levels, inject insulin, or upon placement of a CGM or infusion set. Unfortunately, less than 20% of those with diabetes use soap and water or use a swab. EMIEN HEALTH research suggests the reasons underlying this low compliance is the inconvenience associated with either solution. Rolacol® was created to improve on this compliance percentage.
What makes Rolacol® different than washing hands or using alcohol swabs?
Principally it accomplishes either function of washing hands or using a chemical like isopropyl alcohol in that both are short-term solutions. 1. Rolacol® displaces bacteria around the area before glucose testing, insulin injection, CGM or infusion set placement and 2. Inhibits certain bacteria growth due to its low pH 3.7 (see Active Ingredients.)
Pictures illustrate skin flora displacement. (A) from finger. (B) same finger after Rolacol® applied. Top row 48-hrs. 2nd row 96 hrs. (B) demonstrate skin flora displacement/inhibiting growth. The plates were equivalent to mg/dL 150 >
Hamamelis virginiana (Witch Hazel) a botanical that cleans deep into pores among other benefits such as an astringent to tighten pores that aids in slowing bleeding assisting in faster clotting. It is 100% pure, distilled, and by volume makes up 86% of Rolacol® and has a pH of 3.7. Skin is 4.5 to 5. Most bacteria, particularly Staphylococcus aureus and e-coli don’t flourish in 3.7 pH.
NOTE: Isopropyl alcohol has a pH of 5.5, but, dilution and brand are factors. Hand soap typically has a pH of 8-10 depending on brand. It is often recommend that women do not use harsh, high pH soap in the vaginal area which has a low pH of 3.5-4.5. The acidic ‘natural process’ defends against bacteria that cause most yeast and other infections. High pH soap can reduce acidity (low-pH) and disrupt healthy vaginal bacteria. Rolacol® is formulated on that natural process principle.
Natural grain alcohol, 14%, produced from corn, serves as a Witch Hazel preservative, thus aiding with inhibiting bacterial growth. Natural grain alcohol is different from synthetic chemical alcohols such as isopropyl used in swabs, it is non-abrasive and aids in retaining skin moisture.
100% grade Hydroxyethyl Cellulose (HEC) is a natural gum found within cell walls of plants, particularly pine and spruce trees. HEC is an amino acid used as a preservative, emulsifier, thickener and ingredient binder for many pill-formed medications. Without HEC the liquid Witch Hazel would pour out of the ‘roll-ball’. Used as a thickening agent due to its solubility and its lubricating utility to aid in flora displacement. HEC has bacterial growth inhibiting properties.
Benefits of Witch Hazel
Witch Hazel is a plant with powerful medicinal properties that can be used in a variety of ways – it is a type of shrub native to North America. Witch Hazel is widely known for its ability to ease inflammation and soothe sensitive skin and also cleans deep into pores.
Witch Hazel has been approved for use to treat skin conditions relating to irritation, inflammation and abrasions. It has also been widely accepted for use as a base ingredient in products for chronic skin conditions such as psoriasis, cracked blistered skin, diaper rash and sunburn.
Witch Hazel contains compounds with potent anti-inflammatory properties: 1. gallic acid that research suggests has anti-fungal and anti-viral properties due to its low pH. A National Institution of Health (NIH) referenced study suggests that gallic acid can kill Staphylococcus aureus and e-coli by disrupting the cell membrane. 2. Tannin, a natural plant compound with powerful antioxidant properties that help protect skin against damage. Tannins may also act as a barrier, reducing inflammation causing substances from entering skin cells, hampering bacteria growth.
Reduces Skin Irritation
Sensitive skin, defined by abnormal sensory symptoms affects nearly 45% of Americans. Research suggests applying Witch Hazel to sensitive skin may be beneficial in relieving related issues.
Research suggests Witch Hazel is useful in the treatment of acne. It can be applied directly to the face for cleansing and acts as an astringent, causing tissue to contract to help shrink pores. The same effect aids with slowing blood flow from a glucose finger prick. The astringent effect may prevent acne-causing bacteria from infecting skin. For that reason it is commonly added to many over-the-counter acne products.
Witch Hazel Safety
Most can use Witch Hazel safely with minimal risk of adverse side effects and can be applied to skin several times per day. However, few may experience skin irritation or allergic reactions, therefore, doing an initial skin patch test on a small portion of skin can help prevent unwanted side effects and skin reactions.
In-house Testing, Quality Control and Production
Prior to producing Rolacol® in quantities a blend is tested for pH, viscosity and other characteristics. If approved, a small lot is bottled (prototyped), tried for product flow, dated and stored. Each step in the process is overseen and authorized by a lead supervisor – from lab work to prototyping thru to production, insuring the highest quality product possible.
Quantity and Efficacy
A 10mL Rolacol® bottle is equivalent to approximately 500+ swab applications. Just roll on the skin then rub in for a few seconds. However, after a glucose test or insulin injection it can be reapplied to soothe skin. Depending how liberal the use a 10 mL bottle will last over 60-days. But, once opened, the product’s maximum efficacy is 90-days. Witch Hazel properties, gallic acid and tannins, can lose potency.
Rolacol® is much like soap and water for temporary bacteria displacement but unlike soap it doesn’t need to be rinsed and, unlike soap it will temporarily inhibit bacterial growth. It is a convenient, cost effective pre-emptive solution for bacteria displacement and fits neatly in a kit. And, is eco-friendly no swabs to throw away.
Witch Hazel Supplier
A heritage dating back to 1866, Connecticut based American Distilling, producers of T.N. Dickinson’s products, is also the world’s largest Witch Hazel bulk producer. They are committed to quality and it all starts with the land – 33,000 acres of harvest lands that are carefully selected to ensure the Hamamelis virginiana (Witch Hazel) plants are not exposed to any human contamination. This selection process culminates in a week long inspection and approval by a USDA approved organic inspection agency for compliance with the National Organic Program (NOP).
The Witch Hazel is collected from these approved lands according to strict protocols designed to maintain the Certified Organic Wild Crop status of the harvest. It is then delivered to their Connecticut processing plant where it is held until quality control inspectors test and approve the plant material. Approved plant material is further screened and refined before storage.
The purified plant material is stored in environmentally controlled ceramic lined silos. When needed the plant material is moved to onsite extractors, a closed system to eliminate any possible contamination of the purified plant material. The Witch Hazel is crafted in small batches that are then combined. This process dramatically increases the quality because each small batch is tested, then tested again in the final combined lot.
Witch Hazel extracts are circulated through a preliminary filtration process and are analyzed for quality and purity then circulated through a secondary filtration process for integrity and safety then tested again. The finished Witch Hazel product is passed through a final filtration process as it is transferred to bulk containers.
By the time the finished Witch Hazel, grain alcohol blend reaches EMIEN HEALTH’s Connecticut facility over 100 tests have been conducted. The Witch Hazel pH is then tested, 3.7 is ideal, and the ‘time-consuming’ cold-blending of the HEC process begins to reach the preferred viscosity of 3,300 to 3,500 cps. This viscosity level is perfect for rolling from the bottle and skin absorption of the Witch Hazel.
Rolacol® is not bottled and stored in a warehouse for months, nor gathering dust on some retail shelf. Given it’s an auto-deliver product it is blended on a 30-day schedule guaranteeing the best possible efficacy.