How to Evaluate Surgical Skin Prep Products

ICT introduces a new, regular column in which members of industry suggest strategies for the evaluation and purchasing of infection prevention and control products. This month we take a look at surgical skin prep products.

Participants are:

Jane Kirk, MSN, RN, CIC, clinical specialist for GOJO Industries, Inc.

Milt Hinsch, MS, technical services director for Mölnlycke Health Care U.S., LLC

Tom Engquist, business communications manager of the Infection Prevention Division at 3M

Cindi Crosby, global vice president of medical for Cardinal Health – Skin Prep Solutions

Judson Boothe, marketing director of medical supplies for Kimberly-Clark Health Care

Will Shain, vice president of marketing for monitoring and OR products, Covidien

Hudson Garrett, medical science liaison, Professional Disposables International, Inc.

What is the most critical thing clinicians need to know about reducing skin flora (on the patient and on their own hands) prior to surgery to help prevent surgical site infections?

Kirk: Surgical hand antisepsis is an important part of surgical wound infection prevention. Bacteria left on the hands of the surgeon can rapidly multiply under surgical gloves during a procedure. Reducing resident skin flora on the hands of the surgical team for the duration of a procedure reduces the risk of bacteria being released into the surgical field if gloves become punctured or torn during surgery. The CDC hand hygiene guideline states, “Surgical hand antisepsis using either an antimicrobial soap or an alcohol-based handrub with persistent activity is recommended before donning sterile gloves when performing surgical procedures.”¹ The guideline discusses studies that demonstrate that formulations containing 60 percent to 95 percent alcohol alone, or 50 percent to 95 percent when combined with limited amounts of a secondary antimicrobial lower bacterial count on skin, immediately post scrub more effectively than do other agents.²

Hinsch: The first and most important thing is for patients to be aware that skin flora is an issue. No patient believes he or she is “dirty,” and one of the easiest and most practical ways to reduce the possibility of surgery-related infections is to have every patient come to surgery with clean skin. It sounds simple, but sometimes surgeons and clinicians focus only on cleansing the surgical site and fail to consider the remaining skin; they assume patients know to be clean before coming to the hospital. Patients must be told to cleanse their skin thoroughly for several days prior to surgery. Cleaning under fingernails and toenails is also very important. Although plain, antibacterial soap can be used, there are affordable over-the-counter antiseptic/antimicrobial products that have been available and recommended by surgeons for decades for general skin cleansing to reduce bacterial microflora. Cleansers with chlorhexidine gluconate (CHG) can be critical to reducing bacterial microflora because they cleanse the skin; kill most types of bacteria, including methicillin-resistant Staphylococcus aureus (MRSA); bind to the skin; and continue to kill bacteria for as long as six hours after application. That provides ongoing protection to the surgical area and adjacent skin, especially during the critical, post-surgical recovery time. The most important healing time can be the 24 hours following surgery, when patients come into contact with many healthcare providers, hospital staff, family members and hospital equipment. By having washed with a CHG product that has residual kill, new bacteria are hindered from entering the surgical site. Secondly, just prior to being rolled into surgery, patients need to cleanse their hands thoroughly with an alcohol/CHG wipe, because, following surgery, patients are likely to touch their dressings, IV sites and other areas that can easily be contaminated by the patient’s own hands. Finally, healthcare personnel must always think of the patient’s skin as contaminated, even after prepping. If gloved hands touch the patient’s skin, then the gloves should be considered contaminated and should be changed.

Engquist: In order to obtain the reduction of skin flora claimed by a particular preoperative patient skin preparation, it is critical to follow the application instructions provided by the manufacturer. If a surgical prep time is shortened or if the product is applied beyond the coverage area (typically provided in square inches by the manufacturer), efficacy could be compromised. The instructions for use should be emphasized and clearly presented to clinicians applying the product. Utilizing a simple one-step preoperative prep will help you achieve a standardized process for prepping, decreasing confusion and product misuse.

Crosby: Cutaneous antiseptics must be active against both resident and transient microorganisms on intact skin and reduce their number on the skin by their intrinsic antimicrobial activity, mechanical removal, or both. Healthcare antiseptic formulations have a variety of modes and mechanisms, rapidity of antimicrobial activity, persistent or residual properties, demonstrating varying levels of toxicity. The activity of a cutaneous antiseptic solution can be affected by a number of factors, including the type of microbial species and the nature and concentration of the antiseptic solution. The higher the number of the microorganisms, referred to as the bioburden, the longer it takes to inhibit or kill the individual microorganisms. The exponential decrease in the number of pathogens will require longer exposure times to the antiseptic solution. Another important factor which can influence antiseptic efficacy is the time that the microorganisms are exposed to the agent; the antiseptic needs time to act.

Boothe: Regardless of the skin prep used, bacteria are present on the patient’s skin. As research shows, most SSIs are caused by pathogens from the patient’s own endogenous skin flora and there is no absolute way to sterilize a patient’s skin. Pathogens that remain on the patient’s skin are able to regrow throughout the surgery, which can enter the surgical incision by way of irrigation fluids, gloves, instruments, sponges or implants, putting the patient at risk to develop an SSI. Also, clinicians run the risk of promoting bacterial resistance when using antimicrobial skin preps to sterilize the incision site.

Shain: Prior to every surgical procedure, clinicians are aware of the requirement that they must use an antiseptic solution specifically labeled for surgical hand scrubbing. However, it is vital that they scrub in the stated manner as indicated in the product’s directions for use (DFU). For example, if scrubbing is an essential part of the DFU, it is not recommended to minimize the scrubbing routine. Shortening the stated scrubbing time can be associated with reduced efficacy, and particular focus on the nails and cuticles is important because these are the areas where bacteria are most difficult to remove or kill. The key here is to note that the DFU is an essential component in achieving the stated efficacy of a surgical scrub, and should be followed scrupulously. Patient pre-surgical skin antisepsis must be achieved with an antiseptic product specifically labeled for patient pre-operative skin prepping. Much like a surgical scrub, prep time is critical and the product’s directions for use must be followed. Since alcohol is considered by the CDC Guidelines for the Prevention of Surgical Site Infections to be the most effective single antiseptic active ingredient, it is best to use products that contain a combination of either PVP-I and alcohol or CHG and alcohol. Because of its flammability and the fact that alcohol achieves a substantial amount of kill as it dries, be sure to allow alcohol-based products to air-dry completely before the procedure begins (i.e., “follow the DFU”). Also, when feasible, have patients shower over several days with either a CHG or PVP-I based formulation and/or apply alcohol to the site over several days prior to the surgery.

Garrett: The primary method for reducing flora on the hands is proper hand hygiene either with traditional soap and water or with an alcohol-based handrub when appropriate. Most disease-causing organisms are found in the transient flora, which is located in the epidermal layer of the skin. This flora can be removed using an appropriate skin preparation, such as CHG, prior to a procedure taking place. When using a surgical skin preparation, it is critical to closely follow the manufacturer’s instructions for use in order to achieve the maximum log reduction on the patient’s skin, as well as allow adequate drying time of the solution. Proper hand hygiene technique combined with surgical skin antisepsis will significantly reduce the risk of infection in the patient.

What is your best advice to clinicians for evaluating and purchasing surgical skin preps (for OR personnel and for patients) — what specific features should they look for?

Hinsch: First, it is important to assess clinical needs in order to determine the category of active agents needed or preferred. Basically, there are three categories of products: alcohol-based, CHG or iodine preps. There are pros and cons to each of these agents, and over time clinicians probably have used all of them at least once. But there are important considerations for using each: Will electrosurgical instruments be used? Will there be large quantities of blood on the skin? Do colleagues or patients have preferences for, or irritation from, any of the agents? Because alcohol-based antiseptics are flammable, they can be a more risky choice in surgeries that require electrosurgery, a fact that nurses new to the operating room may not be aware of. Additionally, blood neutralizes iodine, so in cases where large amounts of blood will come in contact with skin, the iodine loses its effectiveness as an active antiseptic. Once the category of skin preparation agents has been selected, then key evaluation criteria typically become ease of application, convenience and outcomes. Only by testing specific products from the categories will clinicians really know which best fits their needs and preferences. In fact, it is recommended that clinicians gather samples and use the potential products in mock procedures with other clinicians to ensure that they meet the ultimate surgical room needs.

Engquist: During value analysis processes, all products being considered should undergo a complete clinical review. Ensure the data provided is pertinent to the operating room environment. Study data should be provided on performance for blood and saline challenge. Another factor which is often overlooked is incise drape adhesion data which can be affected by the prepping product selected. High-risk procedures that involve more fluids can challenge a patient prep and its ability to remain on the skin. Review the products you are considering for water insolubility. Make sure that a leadership team from the OR as well as materials acquisition work together during the value analysis process to develop a plan to utilize a product that users will support, is clinically proven, and meets your cost initiatives. Remember that the evaluation of surgical skin preps should continue after selection and implementation in your facility to measure the performance and patient outcomes.

Crosby: There are various antiseptics which are used throughout healthcare facilities including iodophors, such as povidone-iodine, CHG and isopropyl alcohol. There are specific characteristics to consider when selecting antiseptics for healthcare handwashing, surgeons and OR personnel surgical scrub, and patient preoperative skin preparation. The selection of which antiseptic to use should consider the safety and efficacy, quality of the evidence, ease of implementation, availability of product, and health economic value.

Boothe: There is no doubt that SSIs play a major role in the success of a patient’s outcome as well as its affect to the hospital’s bottom line. Currently, 2 percent to 5 percent of patients undergoing surgery are at risk for SSIs, a major source of morbidity following operative procedures. Compared with uninfected patients, those with SSIs remain in hospitals seven days longer, have a 60 percent increased probability of admittance to intensive care units, are five times more likely to return for continued care within 30 days of discharge and have double the mortality rate. Because of the major focus on infection control (i.e., CMS reimbursements) many manufacturers have developed new products with the key focus of reducing healthcare-associated infections. Of course, this is a good thing for all of us. However, with the increase in infection control products, clinicians are being extremely challenged in knowing which product will have the most impact in helping their facility reduce infections. When evaluating new products, look to see if it has been involved in any clinical studies.

Shain: Both PVP-I and CHG-based antiseptics have been proven safe and effective for surgical skin preparation. However, antiseptic products have far more value than just the active ingredients they contain. Inactive ingredients play an important role in the product’s safety, efficacy, and stability. For example, thickening agents facilitate flow control, help mitigate pooling, and retain more antiseptic in the area being prepped. Film formers can enhance efficacy by localizing the antiseptic and providing some level of barrier protection. A product’s applicator design may contribute to greater user comfort during application and, therefore, more conducive to being used to the full extent of product instructions. Directions for use will also have an effect on performance relative to duration of prep time. For example, a longer prep time may be associated with greater efficacy. Some OR applicators contain glass ampoules which are fractured at the time of use and can represent a safety sharps issue. Others leak valuable antiseptic when inverted which is problematic and may pose a fire safety hazard. The amount of solution provided in each applicator should also be considered. If more than one applicator is required for a procedure, the true cost of application can be two or three times higher than the expected unit cost. Ease of removal of the antiseptic at the conclusion of surgery should also be taken into consideration.

Garrett: Skin preparation solutions should be selected carefully for each patient depending upon both the type of procedure, and also patient’s medical history (i.e., history of allergic reaction to previous skin prep). Other important properties to look for include being broad spectrum, quick, persistent, able to maintain activity in the presence of organic matter, and non-irritating. In addition, the ease of use factor is important and will save clinician’s time when prepping the patient prior to the procedure. The contraindications of the solution of choice should also be adhered to in order to minimize the risk of adverse reactions. Solutions containing isopropyl alcohol also are beneficial by providing a quick initial disinfection of the patient’s skin.

References:

1-2. Boyce, JM and Pittet D. Guideline for Hand Hygiene in Health-Care Settings. Centers for Disease Control and Prevention: Morbidity and Mortality Weekly Report. 51 (RR-16). 2002.