Moisturizing Alcohol Hand Gels for Surgical Hand Preparation - Statistical Data Included

AORN Journal, March, 2000 by Rhonda D. Jones, Hanuman Jampani, Gayle Mulberry, Ronald L. Rizer

Microbial reduction often is cited as a primary weapon in the infection control arsenal. The level of microbial reduction required of an antiseptic or surgical scrub formulation to prevent the transmission of nosocomial infection or the prophylaxis of surgical site infection remains undefined.(1) As a result, the ideal, perhaps elusive, formulation is one that affords the highest antimicrobial efficacy demonstrable against an extensive array of resident and transient pathogens in clinical and laboratory settings and that is designed for frequent use.(2) This ideal formulation has several beneficial qualities, including low irritation, mildness, safety, skin moisturization, and easy and fast application. In addition, as the health care environment is under intense scrutiny to reduce waste, increase efficiency, and reduce expenses related to nosocomial infections, this formulation is obligated to be effective, while saving time and costs and possibly reducing the number of products needed in a facility.(3)

Waterless hand gels that have been independently tested and shown to demonstrate immediate and persistent antimicrobial activity and skin moisturization properties are uniquely qualified to meet all the demands of modern health care and perioperative settings. In this article, a unique 60% ethyl alcohol hand gel with a synergistic antimicrobial preservative mixture for antimicrobial activity is extensively evaluated using

* a health care personnel hand wash test and surgical scrub test,

* skin moisturization studies, and

* latex glove compatibility analyses.

LITERATURE REVIEW

Alcohol long has been recognized for its broad spectrum, fast-acting effectiveness and its convenient waterless application.(4) Two researchers extensively reviewed the mode of action of alcohol hand gels and their efficacy and use in preventing infection.(5) One of these researchers subsequently reported that alcohol-based formulations provided greater initial reductions in microbial flora on hands in the presence of whole blood, over detergent-based formulations containing chlorhexidine and povidone-iodine.(6) A more recent three-year study of respiratory infection rates in a day care facility for older adults found that instituting an alcohol foam for supplemental hand washing did not reduce the respiratory infection rate.(7) In contrast, another set of researchers reported the use of an alcohol formulation as part of a regimen of infection control measures that were implemented successfully to reduce the incidence of ventilator-associated pneumonia caused by methicillin-resistant Staphylococcus aureus.(8)

Alcohol use is widespread internationally and has been shown repeatedly to be superior to detergent-based, topical antimicrobial formulations; however, the use of alcohol for hand antisepsis and surgical scrubbing remains limited in the United States." After revealing the contrasts in the use of alcohol-based products internationally, one study used United States-accepted methodology to demonstrate the efficacy of an alcohol foam.(10) Although a recent discussion suggests that alcohol-based products may be gaining popularity and diverse new uses, the continued lack of acceptance may be due to health care workers' perception of irritation, concerns of additional drying of the stratum corneum (ie, the upper layer of skin), or the lack of substantive antimicrobial activity associated with the products.(11)

MATERIALS AND METHODS

The test methodologies used are fundamental to determining a formulation's compliance with regulatory benchmarks, compatibility with standard use practices, and the requirements of users in a health care setting. To test the efficacy of the 60% ethyl alcohol hand gel for antimicrobial activity, the following tests were performed.

Health care personnel hand wash test. The in vivo antimicrobial activity of a hand gel was measured by evaluating 11 human subjects using the American Society of Testing and Materials (ASTM) Standard Test Method for Evaluation of Health Care Personnel Handwash Formulation.(12) In accordance with federal regulations, an institutional review board approved the study protocol, and researchers obtained informed consent from subjects before the study was initiated. Healthy subjects who had signed consent forms were instructed to avoid contact with antimicrobial or antimicrobial-containing products for at least one week before the study--a list of specific brand-name products to avoid was provided, along with instructions to avoid entering swimming pools and hot tubs. Subjects were supplied nonantimicrobial bar soap and shampoo, deodorant, rubber gloves, and disposable polygloves.

To initiate the study, each subject performed a 30-second hand wash using 40 [ or -] 2 [degrees] C (104 [ or -] 3.6 [degrees] F) tap water and a nonantimicrobial liquid castile soap. The Serratia marcescens strain used for the study demonstrated resistance to amoxicillin, ampicillin, cefuroxime, cephalothin, nitrofurantoin, and tetracycline. Serratia marcescens is a marker organism that acts as a representative transient organism recommended by the ASTM test method. The strain produces a red pigment that allows the test organisms to be distinguished from the test subject's resident flora. Each subject spread three 1.5-mL aliquots of a 20- to 28-hour culture of S. marcescens at 1 x [10.sup.8] colony-forming units per mL over the hands for a total application time of approximately 60 seconds. The bacteria were allowed to air dry on the hands for three minutes. After the initial contamination, a measurement of the S. marcescens on each hand was taken to indicate the baseline.