Product Evaluation & Purchasing Series: Patient Skin Prep and Hygiene

In this new series for 2017, we offer insights from experts in industry and in healthcare delivery regarding smart evaluation and purchasing of infection prevention and control-related products. In this installation, we address patient skin prep and patient hygiene products.

ICT: What are the clinical situations that pose a challenge to the application of skin prep/patient hygiene?

Clinical situations that pose a challenge for skin preps would depend on assessment of each patient and any preexisting conditions that might affect skin turgor and circulation. Wounds, breaks in the skin, the amount of body hair and areas that are considered “wet sites” (i.e., groin, axilla, between skin folds) would all pose potential challenges for skin antiseptic application. Certain chemicals in skin antiseptics may be irritating to non-intact skin, whereas, large amounts of body hair may increase pooling of the antiseptic liquid and therefore increasing the prep dry time. Lastly, areas of the body that are considered “wet sites” are typically body surfaces that stay moist and warm and contribute to heavy growth of bacterial flora. An additional challenge is the ease of prepping the area of the body (i.e., digits, axilla, between skin folds, etc.). In this situation, the applicator of the product needs to easily fit into the area. If the patient is somewhat immobile or incapacitated, additional staff resources would be needed to properly prep the patient. Clinicians also need to assess for patient allergies in regard to ingredients contained within the skin prep solution. Emotional state as well as mental age of the patient along with language barriers could create challenges regarding the understanding of the prepping procedure and its importance in infection prevention. This is extremely important when the prep will be done at home by the patient (i.e., CHG bathing prior to hospital admission) to ensure proper application by the patient.
-- Fran Canty, clinical science liaison, PDI Healthcare
 
Selection of a patient prep is based on multiple factors which include: patient allergies and sensitivities, age of the patient, location/type of procedure, anticipated amount of fluid/blood exposure to the surgical site, and surgeon preference. Once these are evaluated, the prep choice also should consider the following: ease of application, ability to immobilize bacteria on the skin, effectiveness of prep after blood and saline challenge, coverage area and cost/value of each surgical prep being considered.
- Kimberly Prinsen, RN, MSN, technical service specialist, 3M Infection Prevention Division 

Patients with high-risk conditions with non-intact skin, such as graft versus host disease or incontinence-associated dermatitis, where patients experience accelerated desquamation of the skin, patients with Stephens Johnson Syndrome or fungal dermatitis associated with severe obesity, present significant challenges in that the products potent enough to manage the bacterial/fungal infections are caustic and cause cytotoxic responses.
- Steve Woody, CEO of Avadim Technologies

Patient, product, procedure and institutional factors all contribute to challenges involving the application of skin prep/patient hygiene products.  A patient’s general hygiene may warrant additional safeguards such as general patient cleansing or hair removal as a necessary measure prior to procedure start. Time pressures associated with turnover metrics and compliance to manufacturer directions for use are difficult, if not impossible ,because of numerous product offerings and variability with instructions.Some of these products not only increase total time to prep the patient but introduce the risk of over-dilution or cross contamination, which led to the FDA recommendation for single-use patient preps in 2013. Clinical leaders and their staff should be sure to examine the product labeling for skin prep products, consult the literature and contact the manufacturer with usage questions.
- Lena Pearson MS, BSN, RN, CNOR, medical science liaison, BD

Prior to surgery, two patient-centric factors to consider are that skin preparation products must be well tolerated by the patient and easy to apply in order to promote compliance. Both factors are particularly important for pre-surgical patient bathing protocols and for patients who might bathe with a skin antiseptic when in a healthcare facility. In planning surgeries, a key factor that influences the choice of skin preparation is the surgical site that is being prepared. Different body sites have different skin types, contours and endogenous flora, all of which must be taken into consideration when selecting the product to use and the protocol for application. This is particularly the case in urology procedures including intraperitoneal and extraperitoneal surgery; scrotal, perineal, and vaginal operations; endoscopy; and percutaneous renal surgery.1 Neurological and spinal procedures also pose challenges as some antiseptics may be contraindicated for use. Hair on the surgical site also influences what can be used and what can be achieved in terms of skin preparation.2 An additional consideration is whether the procedure will involve a lot of fluids which would necessitate using an antiseptic that will resist being washed off under these conditions. For daily antiseptic bathing, the variety of settings in which patients may need to be bathed such as ICUs and nursing homes can influence the choice of products most practical to use. Finally, the healthcare provider’s knowledge of available products, their cost and efficacy and ease of use must be considered.1
 References:
1. Hemani ML, et al. Skin preparation for the prevention of surgical site infection: which agent is best? Rev Urol. 2009;11(4):190-5.
 2. Sukul V, et al. Optimal Approaches to Skin Preparation Prior to Neurosurgery. US Neurology. 2010;6(2):14-8.
- Richard Lowe, PhD, MPH, senior scientist, Clorox Healthcare

When we think of skin prep, we tend to automatically think about prepping the patient’s skin for surgery. Knowing that surgical site infections are one of the most frequent HAIs, this certainly deserves a lot of attention. Pre-op bathing has been a hot topic at all the Infection prevention and Infectious disease conferences this year. Since the guidelines do not provide definitive recommendations, such as how often and with what product, it becomes difficult for clinicians to know exactly what to do. In many cases, the surgeon decides whether to use soap and water, antibacterial soap, CHG soap or CHG cloths. I have also seen the frequency of bathing range from the night before and morning of surgery, up to every evening for three or five days before surgery. Another important factor that is often forgotten is the type of instructions patients receive. They’re often difficult to follow and it’s hard to determine that the patient actually performed the correct skin prep procedure. We don’t always think about it, but there are some patients that do not have a shower. Hand hygiene for clinicians and staff is also a focal point. Being in a strange place and sometimes being bed-bound can lead to patients abandoning their regular personal hygiene routine. It is up to the clinicians to remind them that basic hygiene is necessary and provide the tools to help them accomplish it. 
- Barb Connell, MS, MT(ASCP)SH, vice president of clinical services, Medline

ICT:What impact does formulation/delivery method have on the efficacy and performance of the skin prep/patient hygiene product and why?

The ultimate goal in skin antisepsis is to reduce the bacterial count on the skin surface prior to the invasive procedure being performed and maintaining residual antimicrobial activity over time to reduce the risk of infection. Formulation of the antiseptic solution plays a major role in the efficacy and performance of the skin prep. The ideal antiseptic solution is one that has broad spectrum efficacy with continuous antimicrobial activity over time, is effective in the presence of organic matter, and has low toxicity and safety attributes. A product that achieves pre-operative skin antisepsis (bacterial log reduction) in the shortest amount of time on the most challenged skin condition containing the greatest bacterial load (such as the groin or other “wet areas”) is preferred by the healthcare provider. All antiseptic solutions must be allowed to fully dry prior to the initiation of the procedure being performed. A solution that is fast-acting and quick drying is a plus. Skin preps are available in various delivery methods. It is important to choose the delivery method that makes the most sense for the procedure that will be performed. The main consideration for choosing the delivery method is based on coverage area needed to be prepped for the procedure. Products may have different coverage areas based on whether the procedure will be performed on a dry site versus a wet site.  Ease of use for the delivery method is very important. A product that is easy and intuitive to use facilitates consistent application. The delivery vehicle should be strong enough to provide friction for log reduction while still being gentle enough to be non-irritating to a vast majority of skin types. Additionally, depending on the procedure being performed, the delivery method should offer the ability to get in between skin folds/digits, under and around catheter insertion sites, or simply apply solution to a larger coverage area. It is important to remember that skin antisepsis is an aseptic technique. The delivery method does not need to be on a sterile field prior to skin prepping. The risk of contamination to the sterile field or scrubbed personnel may be high during the preoperative skin antisepsis activities. A best practice is to prep the patient using aseptic technique and while the solution is drying, the healthcare provider can continue to perform hand hygiene and prepare the sterile field.
-- Fran Canty, clinical science liaison, PDI Healthcare

The application method for a prep is how a prep achieves its efficacy. It is necessary for staff to know and follow the nuances for each prep. Following manufacturer’s instructions for use is critical to not only help reduce the risk of an SSI, but also ensure patient safety. Some surgical skin preparations have different application methods based on the location of the body that is being prepped. For example, when using preps with chlorhexidine gluconate, dry sites (abdomen) have different application time requirements compared to a moist site (groin). These time requirements are necessary for the prep to achieve efficacy. Whereas others preps are applied in the same manner no matter what location they are used on.
- Kimberly Prinsen, RN, MSN, technical service specialist, 3M Infection Prevention Division 

Products offering a non-cytoxic or non-toxic formulation offer significantly improved patient and nursing acceptance, reinforcing compliance and hence reducing risk. Products with high potency typically have poor tolerability scores. The perfect product would be one that offers unparalleled potency with unparalleled tolerability.
- Steve Woody, CEO of Avadim Technologies

Antiseptic formulation plays a significant role in the efficacy and performance of skin prep, but it is not the entire picture. A single-use, hands-off applicator helps clinicians maintain aseptic technique throughout the procedure, reducing the risk of cross contamination from HCW to patient while also reducing the risk of extrinsic contamination of the antiseptic solution due to improper use, handling, or storage. Studies have shown that one-step antiseptics help to increase clinician compliance to manufacturer DFUs, and that the method of delivery is a critical factor in antiseptic efficacy. The combination of an ideal antiseptic agent and delivery method completes the fundamental execution of successful skin antisepsis.
- Lena Pearson MS, BSN, RN, CNOR, medical science liaison, BD

Since products used for skin preparation prior to surgery are applied by the patient at home and by healthcare staff prior to surgery, correct formulation ensures products used are non-irritating and acceptable to patients. This is especially important for home use when compliance to a pre-surgical decolonization protocol can help reduce the risk of surgical site infection. Second, the active ingredients in a formulation can affect the rate at which pathogens on the skin are inactivated. Products containing alcohol, a rapid-acting antiseptic have an immediate effect, while antiseptics containing povidone iodine or chlorhexidine are slower to act, but have greater persistence, meaning that the antibacterial effect lasts longer.  The inactive ingredients in a product formulation can also affect drying time, the amount of antiseptic delivered to the application site, the rate at which it is delivered and the persistence of the antimicrobial effect. The type of surgical site being prepared and the type of procedure will influence which properties are most suitable for skin preparation.
- Richard Lowe, PhD, MPH, senior scientist, Clorox Healthcare

The formulation of the product is important because you have to make sure that other products that the patient may be using are compatible. For example, certain skin products are not compatible with CHG and therefore decrease the effectiveness or inactivate it. The product could also cause skin irritation, especially if used on certain parts of the body, such as mucous membranes on near the eyes or ears. Some patients may actually be allergic to the product, so an alternate antiseptic would need to be used. The CHG cloths and some formulations of CHG soap may be intended to use on the skin and not rinsed off. This can lead to the skin feeling sticky and not the typical “clean” feeling you get with soap and water. Then there are other CHG products that must be left on the skin for about two minutes and then rinsed off. You can see that the instructions for use can become complicated.  Additionally, efficacy of skin prep products can be time dependent. Is the product most effective if it is applied and the incision is made within a certain amount of time? Does the product need to be applied over multiple days for it to be most effective? If you look at surgical site preparation, clinicians were taught for years that when betadine or iodine was used to prep the skin, a circular motion over the surgical site should be used during application. Now [applicator products] are routinely used. These products are applied using friction in a back-and-forth motion. Clinicians need to know and adhere to the prep and drying time or the product may not work effectively.

- Barb Connell, MS, MT(ASCP)SH, vice president of clinical services, Medline

ICT: What are the primary benefits of a skin prep/patient hygiene product that evaluators should look for?

The primary benefits of a skin prep are to prevent risk of infection at time of procedure by minimizing the bacterial flora on the skin and to inhibit re-growth of bacteria during the healing process. Evaluators should be seeking products that include the ideal antiseptic properties of being broad spectrum, fast acting, safe, effective in presence of blood/bodily fluids, easy to use and offers the patient the greatest protection through prolonged activity. Prevention of infection, whether it is surgical site infection or blood stream infection, is a multi-faceted process. The healthcare provider can initiate this process by providing the best antiseptic solution during skin preparation and laying that foundation of safety right at the beginning.
-- Fran Canty, clinical science liaison, PDI Healthcare

Because all commonly used patient skin preps meet the FDA criteria for immediate microbial kill and persistent antimicrobial activity, it’s important to look at other factors that may affect performance when choosing a prep for each surgical patient. If the surgery being performed involves activities that challenge the prep at and around the incision site – with irrigation, wiping and dabbing with surgical sponges, manipulation of the tissue by handling and instrumentation – consider a prep that withstands removal by such activities. Selecting a prep with a water-insoluble film ensures the prep will remain on the skin and continue to provide the patient with antimicrobial protection throughout the procedure. Another factor to consider is prep visibility. When prepping, it is important to not have an “island” of un-prepped skin within the treatment area. Making sure you select a tinted prep that is easy to see will help reduce such a risk.
- Kimberly Prinsen, RN, MSN, technical service specialist, 3M Infection Prevention Division 

A product with potency against multidrug-resistant organisms and a safety profile proven in disease-compromised skin. Typically, the more potent a drug the more side effects; this is the perfect combination - unparalleled safety with unparalleled potency. The caregiver should seek a product that offers a variety of application methodologies and a broad spectrum of use across a wide array of patient types.
- Steve Woody, CEO of Avadim Technologies

Clinicians and other key stakeholders should seek out a patient preoperative skin preparation with a formulation that provides broad-spectrum, rapid and persistent bacterial kill. This formulation should also result in minimal irritation and systemic absorption while maintaining full efficacy in the presence of blood/organic material. Product attributes are not the only considerations; even the best technology can fail if used improperly. For this reason, support from the manufacturer in the form of on-site clinical specialist training is highly desirable. In addition to these benefits, it’s critical that clinical leaders’ practice remains rooted in evidence-based decisions, and proactive literature searches can help with clinically sound decision-making. During a literature search, ensure that the product you are evaluating was examined directly in the study in question, as the slightest change in formulation, application method, or ingredients can change the overall efficacy of a product and render the conclusions made in the literature non-transferrable.
- Lena Pearson MS, BSN, RN, CNOR, medical science liaison, BD

When evaluating patient skin prep products, it’s important to consider efficacy, persistence, tolerability, impact, ease-of-use and cost. Evaluators should look for products with broad activity against gram-positive and gram-negative bacteria with appropriate persistence and that are non-irritating and well-tolerated by patients. HAIs are commonly caused by antibiotic-resistant bacteria which can make infections impossible to treat and extensive resistance is frequently encountered in hospitals. When possible, evaluators should look for products that help enable antibiotic stewardship. For example, clinical data supports the use of povidone iodine, an antiseptic, as an effective alternative to antibiotic ointments for nasal decolonization. Products that are easy to use are more likely to be used compliantly so ready-to-use formats such as pre-saturated swabs are often preferable. It’s also important to select products that are cost effective and add value as part of the facility’s larger infection prevention protocols.
- Richard Lowe, PhD, MPH, senior scientist, Clorox Healthcare

Pre-operative bathing should be looked at not only in terms as a way to help prevent SSI, but also in terms of patient engagement and experience. Studies show that a well-informed patient tends to be more satisfied with the quality of their care and heal faster. Helping the patient to understand what is going to happen from the time of the pre-op visit to after the surgery can help alleviate fears and provide a more satisfying experience.
Here’s a few other things to consider when choosing products:
Patient population: Are you dealing with adults, pediatrics or neonates? Can the product be safely used on your patient populations?
Types of surgeries being performed: Orthopedic or cardiac? There have been more studies performed with the efficacy of CHG in orthopedic and cardiac surgical populations.
Ease of use: Are the instructions for use easy to understand? Is the product easy to apply?
Does the vendor have a solution for monitoring patient compliance?
Can the vendor provide different methods for delivery of the product to the patient?
For oral-care products, look for products that can be used on a number of different patient populations.
Ventilated patients: Oral care that is to the bedside for easy access. If your procedures indicate that oral care should be performed every four hours, then packaging that provides a visual que to let you know if it has been performed would be a benefit.
The other three patient groups that need to be addressed are patients that need assistance with brushing, those with dentures and those who can perform oral care on their own. All tools necessary for performing oral care should be packaged together
- Barb Connell, MS, MT(ASCP)SH, vice president of clinical services, Medline

ICT: How should a skin prep/patient hygiene product be trialed correctly in a facility?

To get accurate feedback, staff involved should have education of the product prior to use. The focus of education is not only how to use the product but why or how the product can contribute to better patient outcomes. Clinicians should have enough time to use trial product a few times prior to providing feedback. Selecting the trial units is also important.  Seeking units who are open-minded and have strong nursing leadership tends to yield best results and the most feedback.
-- Kristi Fleischman, senior director, sales development, PDI Healthcare

When a prep is being trialed for the first time at a facility there should be an in-service for the staff. This ensures application per the manufacturer’s instructions for use which is critical to the prep achieving efficacy which in turn helps reduce the risk of an SSI and ensure patient safety.
- Kimberly Prinsen, RN, MSN, technical service specialist, 3M Infection Prevention Division 

Initially, products should be tested in refractory patients that are failing established standard protocol options. This is the best way to determine if the new skin option can provide value that isn’t currently being recognized for certain patient populations. This helps reduce barrier to entry and will ensure the product isn’t viewed as a line extension. Once proven in the refractory population, the product then should be evaluated in the general patient population.
- Steve Woody, CEO of Avadim Technologies

Evaluating a new product should begin with understanding the evidence. Only products that have shown efficacy in clinical trials and been published in peer reviewed journals should be considered to ensure patient care and safety are upheld.  Initial peer buy-in is important to ensure individual hurdles are overcome early, effectively advancing change management to ensure the evaluation is a success. Before the evaluation, it’s important to learn proper use from the manufacturer and promote a hands-on atmosphere prior to testing with live patients and procedures. During this time, and during the live evaluation, leveraging manufacturer expertise and knowledge of best practice can help ensure proper protocols are followed. This stage also provides an opportunity to evaluate not only the product, but the manufacturer’s level of support and clinical knowledge with your facility’s product knowledge and practice variation. Choosing a knowledgeable vendor and reducing variability is a win-win outcome of product evaluation.
- Lena Pearson MS, BSN, RN, CNOR, medical science liaison, BD
 
A first step would be to review the product documentation, particularly the evidence supporting its use to understand how and under what situations the products should be used, and what the benefits of using the product are. A comparison to the facility’s existing skin preparation products would also help to determine whether the product can replace, or be supplemental to existing skin preparations used. The facility should also request and receive for its staff comprehensive resources and training from the manufacturer or vendor on the correct use of the product to help with its trialing of the product.  During the trial, facility staff should be monitored to ensure compliant use in accordance with manufacturer instructions, and outcomes tracked to assist with product evaluation. During and after the trial, a full review of patient and staff experiences and challenges with using the product, and overall acceptability should be conducted to facilitate decision making on whether to adopt the product in the facility.
- Richard Lowe, PhD, MPH, senior scientist, Clorox Healthcare

Depending on the product, it can sometimes be difficult to do a system wide trial. Picking a unit or two will still provide an opportunity to see the benefits and iron out the limitations before releasing it across the system. Proper communication among staff is key to a good trial and its roll out. It’s important to let the staff know why you are looking at making a change, when the trail will begin and how long it will last. Also, identifying the criteria that will be used to determine if the product meets your needs should also be outlined. As many objective variables as possible should be used, but including some subjective criteria, such as, ease of use, does the product fit in with the workflow, does the staff like the product, is also beneficial.
- Barb Connell, MS, MT(ASCP)SH, vice president of clinical services, Medline

ICT: How should healthcare workers be educated about use of skin prep/patient hygiene product under evaluation?

Educating staff can be challenging but it is vital for successful implementation.  Training end-users is most often done one-on-one in a roaming in-service setting.  It’s important to know what are the “best times” when staff is able to focus on learning, not just checking the box. For example, most EDs have huddle about 15 minutes before shift change so we are able to educate all staff prior to their shift.  Also identifying champions that can support on-going education throughout a unit has been most effective. Vendors can offer the initial education and then use a “train the trainer” process to ensure those involved in the product evaluation have a resource available to address any questions that arise.
-- Kristi Fleischman, senior director, sales development, PDI Healthcare

In-service education regarding the prep, proper application and contraindications for use are key elements to a safe and successful evaluation.  Often times the companies that manufacture the products being trialed support that process by providing individuals on-site for the training. In addition, they have many helpful tools that can be used for the process, such as product application videos, application posters and competency checklists. Additionally, AORN standards recommend that refresher in-servicing is done on a regular basis for all the preps used in a facility to ensure that staff are using each product as intended.
- Kimberly Prinsen, RN, MSN, technical service specialist, 3M Infection Prevention Division 

We have learned a top-down approach is mandatory. If leadership embraces the education and mandates the educational effort it will be adopted. A leadership driven educational platform enhances compliance and compliance drives outcomes.
- Steve Woody, CEO of Avadim Technologies

Education during evaluation is a prime opportunity to improve practice by leveraging manufacturer expertise in patient skin prep. Support from the manufacturer should include comprehensive education with examination, observation, live return-demonstration competency, and literature to support proper use during and after implementation. In addition to this education, the Joint Commission’s National Patient Safety Goals recommends education upon hire and annually on HAI prevention for teams involved in surgical procedures. In the spirit of continuous improvement and in line with NPSF recommendations, manufacturers that provide clinical experts that perform live practice observations, competency development and evaluation, and tailored education programs specific to departmental needs are preferred partners for healthcare institutions.
- Lena Pearson MS, BSN, RN, CNOR, medical science liaison, BD

As with any product-driven infection prevention protocol, to be effective, skin prep and patient hygiene products need to be used compliantly. In the case of SSI prevention, patient safety can hinge on protocol compliance. Accurate and easy-to-follow resources on training and use of the products provided by manufacturers can greatly contribute to compliant use among patients and healthcare providers. Clear instructions for proper product use and education on what to look for during the trial process are crucial and should be supplemented with ongoing training and monitoring to promote compliance. Additionally, given that up to 60 percent of SSIs have been estimated to be preventable using current evidence-based strategies, it is important that healthcare providers receive continuing education on the best practices for skin antisepsis.3-4
References:
3. Meeks DW, et al. Compliance with guidelines to prevent surgical site infections: as simple as 1-2-3?. Am J Surg 2011;201.1:76-83.
4. Umscheid CA, et al. “Estimating the proportion of healthcare-associated infections that are reasonably preventable and the related mortality and costs. Infect Control Hosp Epidemiol 2011;32(2):101-114.
- Richard Lowe, PhD, MPH, senior scientist, Clorox Healthcare

The manufacturer should provide clear, easy to understand instructions for the product. Some vendors provide educational labeling that is printed directly on the packaging so that the instructions can be followed as the procedure is performed. That way there is no second guessing on what needs to be done. In servicing by the vendor is usually performed for a new product. Beyond vendor education, I also believe that competency should be demonstrated. Learn about the product, watch it being used and show how it should be used. After initial training, periodic competency should be performed with staff. This would help to ensure that there is no straying from the written procedure and instructions.
- Barb Connell, MS, MT(ASCP)SH, vice president of clinical services, Medline