What Do You Know About Patient Prepping?

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There is much that remains unknown about the science of prepping.


include "_nav_tab.php";This may surprise you, but science has never proven for certain that antiseptic prepping of a surgical site actually reduces the risk of SSI. Unfortunately, there is more we don't know about prepping as an SSI-reducing measure than what infection control experts know for certain. This is what we do know. We know that human skin harbors a multitude of microorganisms. We know that SSI risk increases markedly with a bacterial concentration of more than one million microbes per gram of tissue. Therefore, most experts believe it makes sense to pre-emptively reduce the bacterial population adjacent to the surgical site incision. Here is a 6-question quiz to test your knowledge on recommended prepping practices. The answers may not be as clear-cut as they seem at first glance.

1. Which of the following statements about patient prepping product regulation is true?
  a) The Food and Drug Administration requires all patient prepping solutions to undergo the same testing criteria to back up its claims
  b) The Food and Drug Administration applies different sets of standards for different solutions
  c) The Food and Drug Administration demands mandatory testing compliance under its Tentative Final Monograph (TFM)
  d) The Food and Drug Administration has accepted chlorhexidine-based into its list of Category I (safe and effective) preparations

2. The new CDC Guidelines for the Prevention of Intravascular Catheter-Related Infections say:
  a) 2% chlorhexidine-based agents are recommended for skin antisepsis before any non-ENT procedure
  b) 2% chlorhexidine is the only acceptable agent for prepping prior to insertion of a catheter
  c) 2% chlorhexidine is recommended for prepping prior to catherization
  d) Any chlorhexidine concentration is equally recommended for prepping prior to catherization
  e) There is no evidence suggesting there is a difference between alcohol, iodophor and chlorhexidine for preventing SSI before any type of procedure

3. Which of the following criteria should not be part of the selection process for a skin prep?
  a) Does the type of procedure affect the length of the prep needed for this patient?
  b) Does the solution irritate the skin?
  c) Do organic matter, soaps and detergents inactivate the solution?
  d) Does the solution have a long duration of action?

4. Which of the following statements about prepping technique is true?
  a) Different products require widely different application techniques
  b) If the agent pools or drips, you haven't applied it properly
  c) You should prep enough area for the surgeon to extend an incision
  d) You can apply the sterile drape immediately after you finish applying the prep

5. For which of the following surgical specialties is chlorhexidine contraindicated?
  a) ENT
  b) General Surgery
  c) Orthopedics
  d) Hand Surgery

6. Which of the following common prepping practices should be contraindicated at your facility?
  a) Draping the surgical site with a non-antimicrobial drape
  b) Requiring patients to shower or bathe with an anti-microbial agent prior to surgery
  c) Shaving the incision site prior to prepping the patient
  d) Routine administration of antibiotic prophylaxis

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Below are the correct answers to the previous questions. You scored =$cor_ans out of =$tot_ques.

1. Which of the following statements about patient prepping product regulation is true?
echo" Answer: ".strtoupper("b) The Food and Drug Administration applies different sets of standards for different solutions")."
"; When it comes to evaluating preps for your patients, be aware that there is a regulatory double standard. The FDA regulates preps in two very different ways. They either require a New Drug Application (NDA) or they are accepted as Category I (safe and effective) under the Tentative Final Monograph (TFM) for Healthcare Antiseptics, published in 1994.

Under the TFM, the FDA recognizes that alcohol and iodine products, although they may have shortcomings in preventing SSI are safe and effective active ingredients. Until a Final Monograph is published (after eight-plus years, there is still one in the works but it is not ready yet and there is no firm date for when there will be one), testing compliance is voluntary for manufacturers of any alcohol based prep or iodophor. When there is a Final Monograph, all manufacturers will have to show the FDA they've done the rigid in vitro and in vivo testing the agency requires. Until then, they are basically on the honor system. However, if you ask for it, reputable companies will often provide the purchaser with supporting information on how they've worked with FDA to comply with the testing standards that accompany their product labeling.

By far, products that need NDAs navigate a tougher road to reach your OR. Companies must provide the FDA with evidence showing safety and efficacy against more than 1,000 strains of bacteria. Any company desiring to market a prepping solution with a new active agent or chlorhexidine must go through the NDA process.

Back when the TFM was written, the FDA considered granting chlorhexidine the same status as alcohol and iodine. However, the agency decided there was not sufficient evidence to do so. Therefore, although CHG is hardly a "new agent" for killing bacteria in the OR, any CHG-based prep must have an NDA before it can be marketed to you.

2: The new CDC Guidelines for the Prevention of Intravascular Catheter-Related Infections say:
echo" Answer: ".strtoupper("c) 2% chlorhexidine is recommended for prepping prior to catherization")."
"; Traditionally, povidone iodine has been the most widely used antiseptic for preparing catheter insertion sites. In the summer of 2002, however, the CDC Guidelines for the Prevention of Intravascular Catheter-Related Infections (page 17) recommended 2% aqueous chlorhexidine prepping for skin antisepsis prior to procedures in which a catheter is inserted. The reason is that studies have shown a decrease in bloodstream infection rates with 2% CHG as opposed to either a 70% isopropyl alcohol solution or a 10% povidone iodine preparation[2]. There has been some misunderstanding about what the CDC guidelines actually say. Here are some key points:

  • CDC's endorsement of CHG pertains only to intravascular catheterization- not for any other type of procedure -and refers only to 2% CHG. Other commercially available preparations of CHG, such as 0.5% CHG may not be as effective.
  • The CDC does not forbid the use of iodine or alcohol for prepping prior to catheter insertion. The guidelines specifically mention that both are still acceptable.
  • The recommendation of 2% CHG is for pre-op prepping only. The CDC does not make a recommendation for a particular antiseptic agent for use cleaning the catheter wound site post-operatively nor do they recommend a specific type of dressing (transparent or gauze). If the catheter site is oozing, gauze may be preferred but either type is appropriate.

Additionally, CDC stresses the importance of sterile barrier protection during intravascular catheter procedures, a step that is just as important as site prepping. The entire area should have a sterile drape. In addition to the cap and mask, a sterile gown, and sterile gloves should be worn and standard aseptic technique should be employed.

3. Which of the following criteria should not be part of the selection process for a skin prep?
echo" Answer: ".strtoupper("a) Does the type of procedure affect the length of the prep needed for this patient?")."
"; The level of prepping necessary with a given agent does not depend on the type of procedure being performed. You should not prep a patient having a small lesion biopsied any differently than a patient undergoing major abdominal surgery. In both cases, you should follow the application instructions on the label.

You cannot and should not compare prepping agents based on off-label usage. Different products have different exposure and drying times. These are certainly factors to consider when comparing the convenience of a prepping solution but you cannot judge clinical efficacy based on the fact that one takes two minutes to apply and the other five.

All of the other factors mentioned in this question-skin irritation, compatibility with organic matter, soaps, detergents and/or alcohol-are important to consider when choosing a prepping solution for the facility. Other factors to consider are the rapidity of microbe kill, whether the solution is flammable (which could be a danger, for example, with alcohol during an electrocautery procedure), and whether the solution is compatible with the surgical gloves in use.

4. Which of the following statements about prepping technique is true?
echo" Answer: ".strtoupper("c) You should prep enough area for the surgeon to extend an incision")."
"; This should not be a difficult question to answer correctly but there are some misconceptions about proper aseptic technique.

Unlike switching from, say, a standard syringe to a safety needle, there are few, if any, technique adjustments needed when using different preps on patients. Some products require a two-step process (scrubbing with a detergent and painting with a solution) and others can be applied in one step. Nevertheless, the same application technique is used, regardless of whether you use a one-step prep or traditional scrub-and-paint iodophor.

There is also much that we don't know about which prepping agents are actually best for reducing SSI. The CDC's 1999 SSI-prevention guidelines state, "no studies have adequately assessed the comparative effects of (preps) in well-controlled, operation- specific studies." We know how effectively and rapidly they kill microbes, how long they last, when and for how long they should be applied and when they are contraindicated for certain procedures or patients.

The best way to determine facility policies and procedures for skin prepping is to do your homework. Review current infection control and medical literature and keep abreast of the recommendations and guidelines from the FDA and CDC as well as professional organizations such as AORN and APIC.

Let's review the key technical steps in AORN's Recommended Practices for Skin Preparation of Patients and CDC's 1999 Guidelines for the Prevention of SSI:

  • Wash hands before handling any prepping solution.
  • Use single-use supplies or use all the solution in a small bottle and sanitize the bottle before refilling it. Never pour unused product back into a larger container or combine unused product from different containers.
  • Clean the patient's skin to remove visible debris and soil prior to applying the prepping solution.
  • Apply the product in concentric circles from the incision site to the periphery, leaving enough area for the surgeon to extend the incision or create new drain sites.
  • Discard the sponge or applicator after you reach the periphery.
  • Allow sufficient contact time for the product before applying sterile drapes.
  • Allow sufficient time for the complete evaporation of flammable agents (alcohol and alcohol-based products).

Some solutions, namely povidone iodine, are notorious for pooling and running. You should take care to prevent pooling of the agent beneath the patient, under tourniquet cuffs, electrodes or electrosurgical unit dispersive pads. This is important in order to reduce the risk of chemical burns and electrosurgical injury.

Finally, some facilities make a practice of leaving the solution on after it is applied, while some practitioners wipe it off. There are no definitive studies that prove one method is superior to the other. However, some one-step prep manufacturers recommend simply leaving the solution on, claiming residual bacteria-killing efficacy from the film.

5. For which of the following surgical specialties is chlorhexidine contraindicated?
echo" Answer: ".strtoupper("a) ENT")."
"; The choice of prepping agent must be appropriate to the surgical site. Therefore, most multi-specialty centers will need to purchase more than one type of prepping product. This is in part because different specialties have different preferences. For example, iodophor-based gels are often popular with orthopedic teams, because the agents are effective on large areas and extremities.

There can also be safety issues involved. Chlorhexidine is contraindicated for the face and mucous membranes, so it cannot be used for ENT surgery, ophthalmology or certain plastics or dermatologic procedures. Severe complications, including potential deafness, are associated with chlorhexidine getting in the ears. The product packing for CHG-based products explicitly notes that the product should be kept away from the face and mucous membranes.

In the CDC's 1999 SSI guidelines, the agency said the following about the applications for the three most commonly utilized agents:

  • Alcohol is highly effective killing bacteria, fungi and viruses, but spores can be resistant. It acts quickly but has a short duration of effectiveness. Alcohol, of course, is also highly flammable and extra precautions should be taken when doing procedures such as electrosurgery.
  • CHG and iodophors both have a broad spectrum of activity. Of the two, CHG may be slightly more effective but either agent will suffice. CHG, however, has better residual activity and is not inactivated by blood or serum.

6. Which of the following common prepping practices should be contraindicated at your facility?
echo" Answer: ".strtoupper("c) Shaving the incision site prior to prepping the patient")."
"; Routine shaving of the surgical site continues in many facilities as a matter of tradition and outdated education. The use of razors for hair removal can traumatize the patient's skin and increase the chances for microorganisms to colonize. Numerous studies and current CDC guidelines increase the risk for skin irritation and infection (see, for example, page 339 of AORN's Recommended Practices). When necessary, clip the body hair at the surgical site, but do not shave it.

AORN recommends performing this step as closely as possible to the time of surgery, prior to entering the OR (hair carries bacteria and you don't want loose hairs falling into the sterile field). Remove as little hair as possible. When hair removal is necessary, an electric or battery-powered clipper with a re-usable or disposable head can be used in between cases.

Draping helps create a physical barrier between the surgical field and the patient's skin and channels potentially infectious fluids away from the patient. AORN highly recommends the practice of draping. While some studies suggest that, for high-risk procedures, draping the surgical site with a sterile drape impregnated with antimicrobial agents can potentially help reduce SSI risk, this has not been proven for certain. Standard sterile drapes can be utilized with equal safety. Likewise, the CDC makes almost no recommendations for routine draping. The agency's only recommendations are to use drapes that are resistant or impervious to liquids and viruses.

There is little conclusive scientific evidence showing a direct link between anti-microbial bathing (such as with chlorhexidine) and reduced SSI rates. That does not mean this step should be omitted. In fact, a good deal of evidence exists to show antiseptic showers greatly reduce microbial colonies on the skin and reduce wound infections. Thus, AORN and other organizations highly recommend antiseptic showers the day prior to surgery (if possible) in conjunction with prepping and other aseptic practices.

Lastly, at least for certain procedures, the administration of antibiotic prophylaxis may be the single most important measure for preventing infection. No matter how carefully we prep and drape the site, it is impossible to keep all unwanted organisms away from the surgical site. By pre-emptively helping the body's immune system, surgical teams can go a long way toward preventing SSI.

Remember, the more preventative steps you utilize when safe to do so, the more remote the possibility of a surgical site infection.

References
1 Mangram AJ, TC Horan, ML Pearson, LC Silver, WR Jarvis, the Hospital Infection Control Practices Committee. Guideline for the Prevention of Surgical Site Infection, 1999. Infection Control Hospital Epidemiology 1999, 20: 247-80.
2 Clemence MA, D Walker, B M Farr. "Central Venous Catheter Practices: Results of a Survey," American Journal of Infection Control, February 1995, 5-12.

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