The Revolution in Skin Protection Safe4hours®

Introduction

The Safe4Hours® line is the most innovative over-the-counter infection control protocol available. The Safe4Hours® line consists of two products: Safe4Hours® First Aid Antiseptic Skin Protectant and Safe4Hours Hand Sanitizer. The Safe4Hours® Hand Sanitizer was launched for the healthcare industry in 2008, while the Safe4Hours® First Aid Antiseptic Skin Protectant will be available beginning in September 2009.

Information specific to the Hand Sanitizer and the First Aid Antiseptic Skin Protectant will be found in sections of this editorial detailing the individual products.

Safe4Hours® First Aid Antiseptic Skin Protectant is formulated with a revolutionary patented polymer technology called Invisicare® and use triclosan as the active ingredient. The polymer technology creates a non-occlusive barrier on the skin and holds active ingredients topically for extended time. As a result, the product is active longer while providing the continuous pathogen kill and allowing normal skin function.

This editorial summarizes the following subject matter with respect to Safe4Hours:
(1) Product Formulation
(2) Results of Research Studies
(3) Safe4Hours Hand Sanitizer
(4) Safe4Hours First Aid Antiseptic Skin Protectant

Safe4Hours® is manufactured in the United States by JD Nelson & Associates and marketed by PDM Healthcare. This is a brief editorial of a very extensive technology and rigorous research studies; more detailed information can be obtained by contacting PDM Healthcare at 440-871-1721 ext 224.

1. Product Formulation

(a) The Polymer Technology – an Innovation in Product Formulation
Safe4Hours® First Aid Antiseptic Skin Protectant is formulated using a ground breaking polymer technology called Invisicare. The technology is a patented process for formation of a complex between hydrophilic and hydrophobic polymers creating in a water soluble emulsion that delivers a wide variety of biologically active agents to the skin for extended periods of time.

The innovative polymer technology imparts Safe4Hours® First Aid Antiseptic Skin Protectant with the following properties:

Persistence: Safe4Hours® First Aid Antiseptic Skin Protectant persists on the skin for hours or until natural skin exfoliation or abrasion removes it.

Protection: Safe4Hours® First Aid Antiseptic Skin Protectant creates non-occlusive barrier on the skin, which is impermeable to many noxious chemicals and environmental pollutants that can damage the skin.

Resists Wash-off: Safe4Hours® First Aid Antiseptic Skin Protectant does not wash off with soap and water or other solvents including but not limited to alcohol.

Non-Occlusive: Safe4Hours® First Aid Antiseptic Skin Protectant allows for normal skin respiration and excretory processes.

Solvent Free: Safe4Hours® is not formulated with alcohol or other drying or defatting organic solvents. It is effective without the addition of these solvents.

Nontoxic & Nonirritating: Safe4Hours® is nontoxic, has an oral toxicity in excess of 5g/kg, and has been shown to be nonirritating to the skin.

Neutral pH: Safe4Hours® is most effective in a pH range of 6.5-7.75.

(b) Active Ingredient
Triclosan 1% is the antimicrobial active ingredient used in Safe4Hours®. Triclosan gives the products the broadest spectrum of pathogen toxicity and has a long history of safe usage with a benign toxicological and skin sensitivity profile.

(c) Product Description
Safe4Hours® First Aid Antiseptic Skin Protectant is available as an opaque smooth white lotion. Some users may experience a slight tackiness upon application (or with use of a larger than recommended application), but any perceived tackiness normally dissipates following a few seconds of application. It is non-greasy and bandages adhere to the product after drying.

(d) Adverse Events & Allergy Profile
Extensive research has shown Safe4Hours® to be a safe product; it is manufactured in compliance with the FDA’s OTC Antimicrobial Topical Product Monograph. To date, there have not been any adverse events or serious side effects associated with Safe4Hours®. The product is not recommended for use by those with an allergy to triclosan. Studies have not been conducted to determine safety of the products’ use by pregnant or breast-feeding women or small children.

2. Results of Research Studies

The study results briefed herein were conducted on the Safe4Hours® products.

Extensive and rigorous laboratory tests were conducted to demonstrate the Safe4Hours® First Aid Antiseptic Skin Protectant patient polymer formulation capabilities and effectiveness in the following areas: persistence, impermeability, safety and preservation of dermatological integrity, antimicrobial activity, product stability, and FHSA Acute Oral Toxicity.

Conclusions gathered from the studies include:

(a) Skin Binding and Moisture Retention
Safe4Hours® First Aid Antiseptic Skin Protectant patient polymer technology demonstrated an ability to bind to skin, trans-epidermal water loss (TEWL) and stratum corneal moisture retention measurements indicated an increase in natural skin barrier protection as well as an improvement in epidermal moisture content over pre-study baselines. Additionally, the formulation was found to prevent skin irritation caused by extensive use of a common 4% chlorhexidine gluconate wash.

(b) Antimicrobial Properties
Safe4Hours® First Aid Antiseptic Skin Protectant and Hand Sanitizer demonstrated bacteriostatic and/or bactericidal effects against a broad spectrum of test pathogens within one (1) minute of contact. Test pathogens included Staphylococcus aureus, MRSA, Enterococcus faecalis, MDR/VRE, Vibrio vulnificus and Escherichia coli.                                                                                                            

Safe4Hours® First Aid Antiseptic Skin Protectant patient polymer formula demonstrated skin persistence and ongoing antimicrobial activity for the full test period of four (4) hours.

A primary benefit of the Safe4Hours® First Aid Antiseptic Skin Protectant patient polymer formulation is its ability to resist adherence of particulate matter. One of the most significant protective properties of the Safe4Hours® First Aid Antiseptic Skin Protectant patient polymer formula is the ability to prevent adherence of  particles, thereby reducing or preventing transmission of infectious particles as well as to reduce adhesion of bacteria to the skin surface during washing. This factor alone will augment reduction of bacterial loads being transferred during the process of proper washing protocols.

Data indicates that use of Safe4Hours® First Aid Antiseptic Skin Protectant on minor cuts, scrapes and burns in the health care environment in combination with proper hand washing techniques will augment the reduction of transient pathogens, thereby helping to prevent nosocomial infections.

There was no visible evidence of cumulative irritation (e.g. redness, swelling) following 14 days of repeated exaggerated patch exposure of the Safe4Hours® First Aid Antiseptic Skin Protectant patient polymer formula using industry standard predictive patch testing. The Safe4Hours® First Aid Antiseptic Skin Protectant formulation ideally will be used for seven days.

There was no visible evidence of sensitization (i.e. contact skin allergy) to Safe4Hours® First Aid Antiseptic Skin Protectant patient polymer formula following industry standard exaggerated predictive patch testing.

(c) Permeability Study Results
For purposes of the user protection, Safe4Hours First Aid Antiseptic Skin Protectant patient polymer formula studies were conducted up to 6 hours post application, 2 hours past suggested re-application time by the manufacturer.

3. Safe4hours First Aid Antiseptic Skin Protectant

Safe4hours First Aid Antiseptic Skin Protectant protects against entry of micro-organisms into minor cuts, scrapes, burns or cracked skin to help prevent infections while speeding the healing process and retaining moisture to the area. It is effective against a broad spectrum of pathogens including MRSA and helps relieve chaffed, chapped or cracked skin (dermatitis).

Safe4hours First Aid Antiseptic Skin Protectant adheres to the stratum corneum and persists for 4 – 6 hours or until natural exfoliation or abrasion removes it. It is impermeable to perspiration, noxious chemicals, and environmental pollutants.

Skin is metabolically active and requires exposure to the atmosphere to execute its normal protective function and remain healthy. A completely impermeable barrier represents an undesirable challenge to the skin. A functional barrier must have selective impermeability to allow the excretion of waste products and simultaneously prevent the intrusion of pathogens. Safe4hours First Aid Antiseptic Skin Protectant allows the skin around a wound and the wound to achieve this balance.

4. Safe4hours Hand Sanitizer

The product is alcohol free, does not sting, and helps moisturize dry chaffed skin. It sooths and speeds the healing of damaged skin and will not cause dry skin conditions that discourage regular use. It is non-allergenic, contains no dyes or fragrances and leaves hands smooth and silky.

Annually, nosocomial infections affect 2 million patients and result in 96,000 deaths. These infections are attributed to transmission from healthcare workers to patients and caused by poor hand hygiene and infection control practices.

While hand hygiene is an integral component of infection control at hospitals and other healthcare facilities, numerous studies show that proper hand hygiene technique and practice is less than optimal among healthcare workers.

Safe4Hours® makes good hygiene and infection prevention compliance easy and effective.

CDC guidelines recommend use of alcohol based sanitizers for healthcare workers. Numerous problems arise with use of alcohol based products, including but not limited to the flammability of the products; dryness, contact dermatitis, and other skin irritation caused by the products which may result in poor compliance. These inherent characteristics of alcohol based products make them less than optimal for their intended purpose in hand hygiene and infection control.

Conclusion

Safe4Hours® is the most innovative infection control protocol available to healthcare facilities. Current infection control practices centered on alcohol based products are less than optimal due to the inherent properties of alcohol. The increasing prevalence of hospital acquired infections, including staphylococcus aureus, HA-MRSA, and other antibiotic resistant pathogens shows that hospitals need to adopt stronger infection control practices for minor cuts, scrapes, burns or openings in the skin of patients and staff.

We believe that Safe4Hours® First Aid Antiseptic Skin Protectant is the solution to hospitals and healthcare facilities’ patients and staff for infection control needs. The products’ strong adherence to skin, strong bacteriostatic properties, non-occlusive, and non-irritating profile make it the ideal infection control product for minor cuts, scrapes, burns, rashes, cracked or chaffed skin in hospitals and healthcare facilities where micro-organism  enter the opening of the skin and cause the nosocomial infections. We believe that Safe4Hours® First Aid Antiseptic Skin Protectant will revolutionize the healthcare industry and create a new standard of care in infection protection.

When using Safe4Hours Hand Sanitizer we recommend washing your hands before applying if dirt or grim are visible. Apply a dime size amount in the palm of your hand, let the product dry and then rinse after drying. Your skin will feel smooth and silky with out the smell of a fragrance or alcohol and will reduce the bacteria load on the skin.
 
Safe4Hours is available in 1oz tube, 2oz bottle, 8oz pump and s16.9oz bags for wall dispenser unit.