CE A Review of Anti-septic Agents for Pre-operative Skin Preparation

Transcription

1 PS2704_ /12/07 23:29 Page 185 CE A Review of Anti-septic Agents for Pre-operative Skin Preparation Mary Beth Digison, BSN, RN Pre-operative skin preparation of the surgical site using appropriate anti-septic product is recognized by the Centers for Disease Control and Prevention Guideline for Prevention of Surgical Site Infection, 1999, as a strongly recommended intervention to prevent surgical site infection. This article reviews anti-septic surgical skin preparation products according to the Food and Drug Administration classifications, efficacy, and safety. It also examines pertinent research regarding anti-septic products. This information provides the peri-operative registered nurse with information to make appropriate decisions when choosing anti-septic skin preparation products for surgical patients. In the late 1860s, the concept of asepsis was introduced into the practice of surgery. The practice of asepsis has revolutionized surgery from a pursuit which frequently resulted in sepsis and death, to a medical intervention, which improves the quality and longevity of life. Despite the radical effect of aseptic technique on the practice of surgery, surgical site infections (SSIs) remain a significant preventable adverse outcome (Mangram, Horan, Pearson, Silver, & Jarvis, 1999). Sterilization of instruments, maintenance of a sterile field, anti-biotic prophylaxis, and hand disinfection have contributed to the reduction of SSIs. These practices combine to create an aseptic surgical environment. In the past, the focus of effectiveness of antiseptic products has been aimed at surgical hand scrubs with little attention being paid to patient skin preparation. The patient s own body, however, Mary Beth Digison, BSN, RN, is a masters of nursing administration candidate, University of Texas at Arlington School of Nursing. Address correspondence to Mary Beth Digison, BSN, RN ( marydigison@texashealth.org). remains a reservoir of potential pathogens. The body s first line of defense is the skin. Invasive procedures disrupt this defense mechanism, allowing the normal endogenous flora to be introduced to the sterile compartments of the body. SIGNIFICANCE An estimated 27 million surgical procedures are performed each year. Of these, 500,000 result in SSIs that comprise at least one third of all nosocomial infections, and are the most common nosocomial infection in surgical patients. These infections are responsible for 77% of the deaths in nosocomially infected surgical patients (Mangram et al., 1999). Many studies show that SSIs increase length of hospital stay and costs. Patients who acquire an SSI double their length of hospital stay and risk of death (Dellinger, 2005). Annual costs associated with increased hospitalization due to SSIs are in excess of $1.5 billion (Seal & Paul-Cheadle, 2004). Despite many advances in infection control, SSIs remain a principal cause of morbidity and mortality (Mangram et al., 1999). According to the Centers for Disease Control and Prevention (CDC), endogenous skin bacteria (Staphylococcus aureus and coagulase-negative staphylococci) cause 34% of all SSIs. Studies show that the risk of SSIs is significantly increased if a surgical site is contaminated with a count of more than 10 5 micro-organisms per gram of tissue. Reduction in the number of these skin micro-organisms may decrease the risk of SSIs. One strategy to reduce the microbial colonization of skin is pre-operative skin preparation. The purpose of pre-operative skin preparation is to decrease resident and transient micro-organisms to subpathogenic levels quickly Plastic Surgical Nursing October-December 2007 Volume 27 Number 4 185

2 PS2704_ /12/07 23:29 Page 186 and to prevent the rebound of growth of microorganisms (AORN, 2006). Pre-operative anti-septic skin preparation products are formulated to remove a broad spectrum of microbes quickly and to provide continuously a high level of anti-microbial action for up to 6 hr after use CLASSIFICATION OF HEALTHCARE ANTI-SEPTICS In the past, many topical anti-microbials were marketed that may have been ineffective or unsafe. To ensure that products used by American consumers are safe and provide action as claimed by manufacturers, the Federal Drug Administration (FDA) Division of Over-the-Counter Drugs regulates anti-septic and other products. According to the FDA, preoperative skin preparation agents fall under the category of healthcare anti-septics and are defined as safe, rapid action, persistent products that act on a broad spectrum of microbes and significantly decrease the numbers of microbes on intact skin. These products must meet the testing specifications established in the FDA 1994 Tentative Final Monograph (TFM) for Healthcare Antiseptic Drug Products. The TFM establishes a framework for evaluation of safety and effectiveness of anti-septic healthcare products. Anti-septic healthcare products are classified into three categories: safe and effective and not misbranded (Category I); not safe and effective or misbranded (Category II); and safety and effectiveness cannot be confirmed because of lack of evidence (Category III). Anti-septic ingredients not listed in the TFM are considered new drugs, which require a New Drug Application before being marketed The FDA TFM has adopted methods proposed by the American Society for Testing and Materials to evaluate the efficacy of pre-operative skin anti-septics. Efficacy pertains to the ability of an anti-septic skin product to significantly reduce the number of resident and transient micro-organisms on the skin. It is expressed as a log reduction. The FDA requires a log 2 reduction on dry sites (i.e., abdomen) and log 3 reduction on moist sites (i.e., inguinal). The immediate action relates to how quickly the anti-septic agent reduces microbial levels. Persistence is the ability of an anti-microbial agent to prevent or inhibit microbial growth on the skin after the product use (Paulson, 2003) (Table 1). The selection of the most appropriate anti-septic product is the most essential step in pre-operative skin preparation. Although the efficacy, immediate action, and persistence of the product are crucial, they must be balanced with need to avoid tissue injury. The safety of pre-operative skin preparation anti-septics are a significant concern for the peri-operative registered nurse (RN). Many skin anti-septics contain ingredients that can cause a direct or indirect injury to the surgical patient. Direct injuries resulting from anti-septic agents include ophthalmic damage, ototoxicity, skin irritations, and anaphylactic reactions. Indirectly, injuries can occur when alcoholic skin preparations ignite, causing fire in the operating room. The RN should have a strong knowledge regarding the efficacy and characteristics of skin anti-septic agents for skin preparation of the surgical patient (Table 2). DESCRIPTION OF SKIN PREPARATION ANTI-SEPTIC AGENTS Chlorhexidene Gluconate Chlorhexidene gluconate (CHG) has immediate, persistent, and residual anti-microbial properties. This product has a strong tendency to bind the tissue, which contributes to its extended antimicrobial action. Depending on the concentration, it exerts bacteriostatic and bactericidal effects on a broad range of gram-positive and gram-negative bacteria. CHG has limited sporicidal activity Iodophor Povidine-iodine (PVI) is the most commonly used form of iodophor and the most widely used pre-operative TABLE 1 Efficacy of Anti-septic Agents Anti-septic product FDA category Broad spectrum Immediate action Persistence Parachlorometaxylenol (Techni-Care-Care-Tech I (safety) Fair Intermediate Good Laboratories, Inc) III (efficacy) Povidine-iodine (ScrubCare-Cardinal Health) I Good Intermediate Minimal Chlorhexidene gluconate (Hibiclens-Molnlycke Health Care) New drug Fair to good Intermediate Very good Isopropyl alcohol/iodophor (Duraprep -3M Healthcare New drug Good Rapid Very good Professionals) Chlorhexidene gluconate with alcohol (Chloraprep -Medi-Flex) New drug Very good Rapid Very good Alcohol with zinc pyrithione (Actiprep-HealthPoint) I Very good Rapid Very good 186 Plastic Surgical Nursing October-December 2007 Volume 27 Number 4

3 PS2704_ /12/07 23:29 Page 187 TABLE 2 Characteristics of Pre-operative Skin Preparation Products Anti-septic product Application Contraindications Safety Products comments Povidine-iodine 7% scrub/10% paint Two steps: Allergy to iodine Avoid pooling, may Safe for use on vaginal (ScrubCare-Cardinal Health) 1. Use scrub solution cause skin irritation area, face and head, for 5 min mucous membranes, lumber puncture 2. Wipe on paint solution, Children 2 months allow to dry Iodophor 0.7%/isopropyl alcohol Paint single uniform Allergy to iodine May cause serious Improves occlusive drape 74% (Duraprep -3M Healthcare application injury to eyes, ears adhesion Professionals) if allowed to enter and remain 3-min dry time Children 2 months Flammable, allow to May be left on post-op for dry before draping continued bacterial kill Not for open wounds, OK for spinal tap or epidural head and neck, catheter mucous membrane Chlorhexidene gluconate Swab liberally to Not for use on face, Rare, serious allergic OK for superficial wound 4% (Hibiclens-Molnlycke surgical site 2 min head, meninges, reaction Health Care) genitals, deep open wounds Sensitivity to ingredients Serious eye/ear damage Repeat procedure Children 2 months for 2 min Chlorhexidene gluconate Dry site (i.e., abdomen Not for use on face, Flammable: Allow to Effective in presence of blood 2%/isopropyl alcohol 70% and arm): Back head, meninges, dry before draping or organic matter (Chloraprep -Medi-Flex) and forth motion genitals, deep open with applicator for wounds 30 seconds Wet site (i.e., inguinal Allergy to CHG Avoid contact with and axilla): Back and eyes, ears, mucous forth motion with membrane applicator for 2 min No blot; allow to dry Children 2 months for 3 min Chloroxylenol 3% (Techni- Full strength Sensitivity to None Safe for mucous membranes, Care-Care-Tech ingredients face, around eyes, ears, Laboratories, Inc) vaginal prep Apply directly to Children 2 months surgical site or air dry Alcohol 73%/zinc pyrithione One uniform, thin Sensitivity to Flammable: Allow to Nonirritating to skin (Actiprep-HealthPoint) application ingredients dry before draping Dry for 2 min Not for use on Avoid contact with Avoid pooling mucous eyes membrane Not for use nonintact skin skin anti-septic. This product has an excellent immediate anti-microbial effect. PVI has good local tolerability: it is not irritating or painful to the skin. It is effective against gram-positive and gram-negative bacteria, fungi, and protozoa. With the appropriate length of exposure time and concentration, iodophors are also effective against mycobacterium, spores of Bacillus spp and Clostridium spp. PVI may be less effective in the presence of blood, necrotic tissue, or purulence Parachlorometaxylenol One of the oldest anti-microbials, parachlorometaxylenol (PCMX, also known as chloroxylenol) is relatively safe for human use. It has fair to good anti-microbial Plastic Surgical Nursing October-December 2007 Volume 27 Number 4 187

4 PS2704_ /12/07 23:29 Page 188 efficacy. It is not widely used as a skin preparation agent because of its comparatively less effective anti-microbial action Alcohol and Alcohol-Based Agents Alcohols are broad spectrum, fast-acting antimicrobials. They are ineffective against bacterial spores but generally effective against fungal species and some viruses. Although alcoholic anti-septics have excellent immediate anti-microbial action, they have limited persistence and residual effects Currently, many products incorporate alcohol along with other anti-septic agents to address the lack of persistence of alcohol. The addition of other antiseptic agents such as iodophor or CHG to an alcoholbased agent is necessary to extend its persistence. Another strategy to improve persistence of alcohol is to add a preservative such as zinc pyrithione (ZPT). The addition of ZPT provides persistence to alcohol that is absent if it is used alone. This combination of alcohol and ZPT demonstrates rapid reduction of resident and transient flora, which exceeds FDA requirements (Seal & Paul-Cheadle, 2004). The combination of alcohol with CHG shows an improvement in immediate anti-microbial properties that provide superior clinical efficacy as a skin antiseptic agent. The CHG component of this combination results in persistent anti-microbial action (Paulson, 2003). Another anti-septic agent, which may benefit from the addition of alcohol, is iodophor. The combination of isopropyl alcohol and iodophor results in a product with immediate efficacy that requires less time for application in comparison with typical iodophor agents (Segal & Anderson, 2002). REVIEW OF PRE-OPERATIVE SKIN DISINFECTION RESEARCH A number of studies have examined the most effective skin anti-septic agent for infection prevention in central venous pressure (CVP) catheters. A metaanalysis of vascular catheter site studies found CHG to be more effective in preventing catheter-related bloodstream infections than povidine-iodine (Chaiyakunapruk et al., 2002). On the basis of these studies, the CDC has published guidelines specifically recommending 2% CHG as a skin preparation agent before insertion of CVP catheters (CDC, 2002). Unfortunately, there is no definitive guideline for pre-operative skin anti-septic agents. Although PVI is categorized by the FDA as a Category I (safe and effective) skin anti-septic, studies have demonstrated greater immediate and persistent anti-microbial action by other anti-septic agents. One study demonstrated that the addition of alcohol to PVI results in a more efficacious anti-septic agent. Segal and Anderson (2002) found that SSI rate was lower in cardiac surgical patients who had skin preparation with an iodophor/alcohol product versus PVI. The authors note that the combination of iodophor and alcohol in a water-insoluble film provides anti-microbial effects for up to 12 hr after application and provide a bacteriostatic action under a dressing for up to 3 days. Hibbard (2005) conducted clinical trials to determine the best pre-operative skin preparation agent on the basis of three criteria: immediate, persistent, and cumulative action. He found that the combination of CHG and alcohol was superior in all three criteria in comparison with four other anti-septics: 70% alcohol, 2% CHG, and 4% CHG or PVI. Ostrander, Botte, and Brage (2005) compared the combination of CHG and alcohol, PVI and alcohol, and chloroxylenol alone on pre-operative skin disinfection of the foot and ankle. They found that the combination of CHG and alcohol was the most effective agent for eliminating bacteria from the foot. Guthery, Seal, and Anderson (2005) compared a skin anti-septic formulation of ZPT/alcohol with iodine/chg. They concluded that this product exceeded the efficacy of both CHG and iodine. Seal and Paul-Cheadle (2004) tested ZPT with alcohol in a systems approach to pre-operative skin preparation, which included washing of the sites at 12 and 6 hr before the pre-operative skin preparation using either the ZPT with alcohol product or 10% PVI. The alcohol-based product demonstrated greater antimicrobial efficacy than the iodine-based product at nearly every test point and continued beyond the wound closure. There are few studies that assess the effect of preoperative skin disinfection on SSI rates. However, logic dictates that eliminating the microbes, which are implicated in most SSIs, will decrease infection rates. The anti-septic products with the broad spectrum, immediate, and persistent anti-microbial properties should be the product of choice for the pre-operative preparation of skin. As this review indicates, products that combine alcohol with CHG, PVI, or ZPT may be the most effective skin disinfectants. In products without any alcohol, CHG alone is the more effective and persistent skin anti-septic than PVI. CONCLUSIONS SSIs are a significant issue for healthcare providers. According to the CDC (Mangram et al., 1999), techniques aimed at reduction of microbial contamination of the patient s tissue are an important prevention measure for SSIs. Effective pre-operative skin disinfection provides an opportunity to reduce SSIs. 188 Plastic Surgical Nursing October-December 2007 Volume 27 Number 4

5 PS2704_ /12/07 23:29 Page 189 Anti-septic agents for skin disinfection must be selected on the basis of efficacy and safety. This requires that peri-operative RNs have thorough knowledge of product characteristics and manufacturer s instructions for each anti-septic product. The informed RN is able to choose among the available anti-septics for the most appropriate skin disinfection product to protect each patient from SSI. REFERENCES AORN. (2006). Standards, recommended practices, and guidelines. Denver, CO: AORN Publications. Cardinal Health. Prep and skin care. Retrieved April 23, 2007, from patientprep.asp Care-Tech Laboratories, Inc. Antiseptics, wound infections, topical infections. Retrieved April 23, 2007, from www. caretechlabs.com/cart/ctl-products-technicare.html Centers for Disease Control and Prevention. (2002). Guidelines for the prevention of intravascular catheter-related infections. MMWR Morbidity and Mortality Weekly Report, 51(RR10), Chaiyakunapruk, N., Veenstra, D. L., Lipsky, B. A., Saint, S. (2002). Chlorhexidene Compared with Poridine-Iodine Solution for Vascular Catheter-Site Care: A Meta-Analysis. Annuals of Internal Medicine 136(11), Dellinger, E. P. (2005). Increasing inspired oxygen to decrease surgical site infection. Journal of the American Medical Association, 249(16), Food and Drug Administration. (1994). Topical antimicrobials drug products for over-the-counter human use: Tentative final monograph for healthcare antiseptic drug products Proposed rule. Federal Register, 59, Guthery, E., Seal, L. A., & Anderson, E. L. (2005). Zinc pyrithione in alcohol-based products for skin antisepsis: Persistence of antimicrobial effects. American Journal of Infection Control, 33(1), HealthPoint. Actiprep. Retrieved April 23, 2007, from Hibbard, J. S. (2005). Analyses comparing the antimicrobial activity of current antiseptic agents: A review. Journal of Infusion Nursing, 28(3), M Healthcare Professionals. 3M TM Duraprep TM Surgical Solution Iodine Povacrylex [0.7% available iodine] and isopropyl alcohol, 74% w(w) patient preoperative skin preparation. Retrieved April 23, 2007, from 3m.com/catalog/us/en001/healthcare/professional/node_ GSF83Z3YYXbe/root_GST1T4S9TCgv/vroot_F9G ge/gvel_jlrv63sxxbgl/theme_us_professional_3_0/ command_abcpagehandler/output_html Mangram, A. J., Horan, T. C., Pearson, M. L., Silver. L. C., & Jarvis, W. J. (1999). Guideline for prevention of surgical site infection, Atlanta, GA: The Hospital Practices Advisory Committee, Centers for Disease Control and Prevention, Public Health Service, U.S. Department of Health and Human Services. Medi-Flex. Chloraprep The rapid-acting, persistent, and superior preoperative skin preparation. Retrieved April 23, 2007, from index.html Molnlycke Health Care. Hibiclens. Retrieved April 23, 2007, from &si 182 Ostrander, R. V., Botte, M. J., & Brage, M. E. (2005). Efficacy of surgical preparation solutions in foot and ankle surgery. Journal of Bone & Joint Surgery, American Volume, 87(5), Paulson, D. S. (2003). Introduction to topical antimicrobials and their applications. Handbook of topical antimicrobials: Industrial applications in consumer products and pharmaceuticals. New York: Marcel Dekker Inc. Seal, L. A., & Paul-Cheadle, D. (2004). A systems approach to preoperative surgical patient skin preparation. American Journal of Infection Control, 32(2), Segal, C. G., & Anderson, J. J. (2002). Preoperative skin preparation of cardiac patients. AORN Journal, 76(5), Plastic Surgical Nursing October-December 2007 Volume 27 Number 4 189