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PURELL Waterless Surgical Scrub
Provides Efficacy Without Skin Irritation
4/30/2010
Exceeds FDA requirements and is skin-friendly
The days of having to use a surgical scrub that is harsh to the skin are over thanks to PURELL® Waterless Surgical Scrub from GOJO Industries.
Designed to meet and exceed FDA1 and AORN (Association of periOperative Registered Nurses) surgical scrub requirements without the addition of ingredients that may be harsh to the skin, the PURELL Waterless Surgical Scrub formulation (70% ethyl alcohol) provides the bacterial kill and persistent activity critical to the surgical environment.
"As we all know, surgical scrubs were developed for several critical purposes. In addition to significantly reducing resident microorganisms from the hands of surgical team members, surgical scrubs slow microbial repopulation, thus reducing the potential risk of microorganisms being transferred into a surgical wound," said Portia Ash, GOJO Marketing Director for Acute Care.
Ash continued, "We know that surgical team members are constantly faced with the harsh effects of traditional surgical scrub formulations. So, we decided to challenge the assumption that effective scrubs routinely cause skin irritation. After a number of third-party studies were conducted, we are pleased to note that the results have been very positive. Proven to be mild, PURELL Waterless Surgical Scrub has been proven to reduce and eliminate microorganisms from the hands of the surgical team members while at the same time, provides a rapid antimicrobial kill of a broad spectrum of microogranisms."
Antimicrobial efficacy exceeding FDA guidelines
According to the FDA Tentative Final Monograph (TFM) for Health Care Antiseptic Drug Products testing requirements, surgical scrubs must provide both immediate kill and a "persistent" effect. In a study conducted at a third-party independent clinical testing laboratory,2 PURELL Waterless Surgical Scrub was tested according to FDA guidelines. The study compared PURELL Waterless Surgical Scrub to a 4% CHG reference product.
Subjects used PURELL Waterless Surgical Scrub formulation a total of 11 times over a five-day period to measure the reduction of resident hand microflora. Results demonstrated that the product meets the reduction immediately after the first wash on day one, a 2-log (99%) reduction immediately after the first wash on day two, and a 3-log (99.9%) reduction immediately after the first wash on day five. Furthermore, the bacteria count did not exceed baseline within six hours (under glove occlusion) on day one. Thus, the study demonstrated that the PURELL Waterless Surgical Scrub offers antimicrobial efficacy, not only killing bacteria immediately, but also inhibiting the re-growth of microorganisms for six hours.
Low potential for skin irritation
A separate study3 was performed to measure the potential for PURELL Waterless Surgical Scrub to cause skin irritation. Using traditional industry research protocols, a 21-day evaluation of skin irritation potential in humans caused by surgical scrubs was performed by applying different products, including PURELL Waterless Surgical Scrub daily, five days per week, for 21 days to the same site on different test subjects. For PURELL Waterless Surgical Scrub, the average obtained score was 0.02 on a scale of 0 to 4, with 0 indicating that no irritation occurred. "We confirmed that PURELL Waterless Surgical Scrub has a low potential for skin irritation and allergic contact dermatitis. The 21-day cumulative irritation test data showed that the PURELL Scrub is significantly less irritating than three of the competitive products tested," said Ash.
"When the high alcohol content of PURELL Waterless Surgical Scrub, which has been proven to kill both resident and transient bacteria immediately upon contact, is combined with a patent-pending blend of inactive ingredients, the alcohol works even harder. The result is an advanced alcohol formulation that kills bacteria on contact, penetrates the skin more completely than alcohol alone to reach more resident bacteria, and creates a pH-balanced environment that helps inhibit bacteria recovery and re-growth," said Ash.
Compatible with gloves and CHG
Additional studies were performed in an independent third-party clinical laboratory2 to confirm that PURELL Waterless Surgical Scrub is compatible with latex, neoprene and polyisoprene gloves, along with a CHG surgical scrub. Following the ASTMD5151-99 standard, glove samples were immersed in the product for a period of two hours and then examined for leaks. The control samples were not exposed to the product. PURELL Waterless Surgical Scrub was tested on 100 control gloves and 100 latex, polyisoprene and two brands of neoprene gloves, for a total of 400 test gloves. Results indicated that PURELL Waterless Surgical Scrub does not impact the integrity of latex, neoprene or polyisoprene surgical gloves. An additional compatibility study to measure the effects of PURELL Waterless Surgical Scrub on the antimicrobial properties of a known CHG surgical scrub indicated that PURELL Waterless Surgical Scrub is compatible with CHG.
Dispenser features
PURELL Waterless Surgical Scrub is dispensed from a TFX™ Touch Free Dispenser. This dispensing system is easy to install, use and maintain. It uses only SANITARY SEALED™ refills. The 1200 mL refills provide more scrubs than other dispensing bottles in the market. A fresh dispensing valve is provided with every refill. the dispenser has a skylight that makes it easy to see when it is time to refill the dispenser, and the unit, operated by standard C-size alkaline batteries, is fully ADA-compliant and fire code compliant.
Available dispenser accessories include a wall spacer, which offsets the dispenser from the he wall to help prevent contamination from any microorganisms on the wall; a surgical sink bracket, which enables the dispenser to be mounted on a sink to support a scrubbing environment familiar to an operating room staff, and an AT-A-GLANCE™ SERVICE REFILL ALERT™, featuring a flag that indicates when a dispenser needs to be refilled.
For more information
PURELL Waterless Surgical Scrub is part of a complete line of hand hygiene products from GOJO. For more information, call the GOJO Customer Interaction Center (CIC) at 800-321-9647, or sign up for a trial at www.GOJO.com/Healthcare-Trial.
About GOJO
GOJO Industries, inventors of PURELL® Instant Hand Sanitizer, distributes PURELL in away-from-home markets throughout the world. In addition, GOJO manufactures and distributes a full line of products under the GOJO® and PROVON® brand names. GOJO has a 64-year history of leadership in improving well-being through hand hygiene and healthy skin. GOJO has products and programs to kill germs on hands and solve skin care-related problems in a variety of settings, including healthcare, foodservice, food processing, manufacturing, automotive, education, government and military. GOJO is a privately held corporation headquartered in Akron, Ohio, with offices in the United Kingdom, Japan and Brazil.
PURELL is a trademark of Johnson & Johnson and is used under license.
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