If you are confused about which surgical prep is the most effective, convenient and economical, join the club. A regulatory vacuum left by the Food and Drug Administration combined with intense competition among manufacturers has led to a sea of especially confusing claims and counterclaims.

Though this article certainly won't solve the problem, hopefully it will help. To follow, we'll explain what the government says (and doesn't say) about the efficacy of the various surgical preps, and then let most of the key players in the prepping market have their say about what sets their products apart from their competitors.

An information vacuum
When evaluating preps, surgical facilities should understand that they are basically on their own. Government agencies are of little help in this area. With a few exceptions, it's up to each facility to weigh the claims and counterclaims about each product and make the best judgement it can.

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First realize that preps are regulated in two very different ways.

By far the most rigorous is the FDA's New Drug Approval process. If a company takes this route, it must do extensive tests to prove the product's safety, and test efficacy against more than 1,000 strains of bacteria. Purdue-Frederick's Betadine, Regent Medical's Hibiclens and Medi-Flex's ChloraPrep all came to market this way. Today, any company desiring to market a prep containing a new active agent or chlorhexidine must still submit a New Drug Application prior to marketing.

Companies marketing under an NDA must observe strict labeling criteria. Making claims outside of the labeling risks sanction by the FDA. If a product has an NDA, it is almost sure to live up to its labeling, whatever its other attributes.

But products without an NDA whose active ingredients are something other than iodine or alcohol fall into an odd, much more lightly regulated category, where for right now, companies are essentially on their honor to prove safety and efficacy.

In 1994, the FDA published a document called the Tentative Final Monograph (TFM) for Healthcare Antiseptics. The document, the product of a long, involved process, was meant to give notice of how the FDA proposed to regulate several antiseptic products, including preps.

Basically, the FDA proposed that it recognize that alcohol and iodine products, whatever their shortcomings, are safe and effective as active ingredients for preps. It proposed that virtually all other active ingredients are unproven, and require extensive, relatively rigid and costly in vivo and in vitro tests to prove safety and efficacy. It also advanced a fairly rigid plan for regulating the claims companies could make about preps on their labels and in their promotional materials.

The catch is that even after eight years, the FDA still hasn't finalized the rule. Until it does, compliance is voluntary, and companies not marketing under an NDA enjoy wide latitude in the promotion of their products.

While most manufacturers have worked to bring their products into compliance with the TFM, in anticipation of a final ruling, others have done little, and none have had to submit evidence to FDA that they are in compliance. With the absence of regulatory oversight, many prep makers are pointing fingers at one another, accusing each other of not being in compliance. Be-cause of this lack of regulation, surgical facilities can't rely on the FDA when it comes to judging preps not regulated by an NDA.

Only vague guidance is available from another government agency, the Centers for Disease Control.

In its "Guideline for Prevention of Surgical Site Infection," published in 1999, the agency states "No studies have adequately assessed the comparative effects of (preps) in well-controlled, operation specific studies." The agency adds the following:

• Alcohol is highly effective against bacteria, fungi and viruses, but spores can be resistant and alcohol is highly flammable, a disadvantage in the OR.
• Chlorhexidine gluconate and iodine-based products both have a broad spectrum of activity, but of the two chlorhexidine is probably slightly more effective, has better residual activity and is not inactivated by blood or serum proteins.

The document makes no comment about other agents.

Over the summer, the CDC formally recommended 2% chlorhexidine prepping for skin antisepsis before procedures in which a catheter is inserted. According to CDC, other preparations of chlorhexidine may not be as effective, at least not for catheter insertion. The agency does say that iodine- and alcohol-based products are still acceptable. The recommendations did not extend to other types of procedures.

What manufacturers say
With the rules of the game in mind, consider what makers say about their products and others:

3M DuraPrep Surgical Solution
3M's DuraPrep Surgical Solution, introduced in 1987, is a non-aqueous iodophor containing 74% isopropyl alcohol.

According to 3M's market development manager Mardi Bentzen, the key benefits of the product are as follows:

• The alcohol provides an excellent immediate kill rate, and the iodine, contained in a non-aqueous film vehicle, has post-op benefits. Ms. Bentzen notes two independent studies showing that bacteria contacting DuraPrep film are killed for at least 12 hours and low bacteria counts are maintained under transparent dressings for up to three days. An in vitro study comparing DuraPrep film with Betadine showed that the former released more iodine than the latter over a three-hour period. ¹
• The product enhances drape adhesion during a procedure.
• The container is easily disposed of after the procedure, because the glass ampoule in which the product is delivered is enclosed in a crush-resistant plastic applicator. Therefore, it need not be disposed of with your sharps.
• Contrary to competitor claims, removal is easy. Although soap-and-water removal is not possible, either isopropyl alcohol on a gauze sponge or a 3M removal lotion will work. 3M recommends leaving the product on for as long as possible to obtain maximum post-op residual bactericidal protection.

Prevail-Fx
Prevail-Fx from Allegiance is a one-step aqueous iodophor/isopropyl alcohol solution (Prevail, first introduced in 1998, is a gel). Michelle Gast, Allegiance's market manager for prep and skin products, says the product offers several benefits:

• The solution applies in 30 seconds.
• A study published in the December 2001 American Journal of Infection Control, provided to Outpatient Surgery, shows a 99.99 percent bacteria kill 15 seconds after application. The study also shows that the solution dries quickly and has residual efficacy for more than 24 hours after application. Allegiance claims that because Prevail-Fx maintains a degree of solubility but is water-resistant, the solution releases free iodine to increase bacteria kill, says Ms. Gast. She contests arch-rival 3M's contention that its non-aqueous vehicle improves its longevity. She believes the film may render the iodine less effective.
• The applicator has flow-control, reducing pooling.
• The Prevail-Fx film produces enhanced drape adhesion.
• Prevail-Fx can be removed with soap and water.

ChloraPrep One-Step
Manufactured by Medi-Flex, ChloraPrep contains 2% CHG and 70% isopropyl alcohol. Cynthia Crosby, Medi-Flex's director of clinical education, points to the following benefits:

• ChloraPrep exceeded FDA standards in clinical trials. Ms. Crosby provided a study of 85 subjects, testing the solution against 2% CHG and 70% isopropyl alcohol, showing ChloraPrep is "safe, with immediate bactericidal efficacy and significantly greater reductions in bacterial counts at 24 hours compared to Aqueous CHG."
• ChloraPrep remains active in the presence of blood and organic matter; whereas iodine is neutralized.
• The product lasts a long time; she says a study shows strong residual post-surgical bacteria killing over a five-day test period.
• The alcohol provides a quick kill while the chlorhexidine provides persistent antimicrobial activity. The data the company presented to FDA showed that a single 30-second application of the solution (two minutes for wet sites) constituted a "safe and effective" surgical prep, she says.
• It is ideal for catheter procedures. Ms. Crosby says that not only do CDC guidelines specifically recommend 2% CHG, they also point to 70% alcohol as an acceptable prep. Chloraprep contains both.
• The applicator allows for controlled release, limiting the possibility of pooling .
• A comparative study (Protocol CXA1004) included in ChloraPrep's NDA shows that 2% CHG is much less irritating to skin than PVP-1.

Techni-Care
Techni-Care, from Care-Tech Laboratories, contains the active ingredient 3% chloroxylenol (PCMX). Sherry Brereton, Care-Tech's vice president of sales and marketing, contends that independent in vivo and in vitro testing data "fully substantiates" that the product not only disinfects faster than any competing solution, it does so with fewer potential drawbacks. (Outpatient Surgery could not obtain copies of the studies). Specifically, she says:

• Techni-Care works quickly and effectively. The company claims lab tests show 99.99% effectiveness in killing gram-positive and gram-negative bacteria within 30 seconds of contact with no known organisms resistant to it. The intense speed at which the product eliminates bacteria leaves little chance of future mutations or resistance from bacteria at the surgical site, she believes.
• The solution is persistent. Ms. Brereton says the product remains effective for more than six hours and is superior to iodine because it does not become denatured by organic matter.
• The solution is very mild, non-toxic even to the eyes and mucous membranes, making it particularly well suited to specialties such as gynecologic surgery, she says. (FDA's TFM reinforces this claim).
• The solution works as a surfactant as well as a disinfectant.
• Unlike iodophors, Techni-Care is non-staining.
• The product is cost-effective because only 2.5 ml of Techni-Care is necessary in a single prep, whereas 10 ml of CHG solutions and Betadine are necessary for one prep. Over time, each container goes a lot further.

Actiprep and Triseptin
Manufactured by Healthpoint, Actiprep is a one-step prep solution. The company also manufactures Triseptin, a pre-surgical body wash. The products are available separately but the manufacturer promotes using them in combination. Both are based on "Trizenol," a combination of alcohol, surfactants and emollients, and the preservative zinc pyrithione. Product Manager Shawn Gentry says the following sets apart the product duo:

• The tandem use conforms to the 1999 CDC Guidelines for Prevention of Surgical Site Infections, which "strongly recommend" that patients "shower or bathe with an antiseptic agent on at least the night before the operative day." Healthpoint recommends two washes prior to surgery with Triseptin followed by one uniform, thin application of Actiprep in the OR. According to Mr. Gentry, in vivo clinical studies show the dual approach reduces the baseline microorganism population by 3.15 logs 10-minutes post prep on an inguinal site, a rate superior to both scrub-and-paint PVP-1 and a double CHG wash with PVP-1 prep.
• Actiprep takes around 30 seconds to apply and dries in about a minute. Mr. Gentry says this saves 10 to 15 minutes as opposed to scrub-and-paint iodine.
• The two products provide strong residual activity for at least 48 hours post-op, he says.
• Actiprep forms a film that enhances drape adhesion.

Hibiclens
Hibiclens, from Regent, is a 4% CHG solution also containing 4% isopropyl alcohol. Regent product manager Rollie Kitchens spells out these advantages to using Hibiclens:

• NDA testing showed it to be bactericidal on contact against a broad spectrum of bacteria. "The immediate bactericidal action of chlorhexidine surpasses that of similar preparations containing povidone iodine, triclosin, hexachlorophane or PCMX." ²
• A clinical study provided to Outpatient Surgery shows that in a study of 341 vascular surgery patients, a pre-op shower with Hibiscrub reduced post-surgical infections from 19.5 percent to 7.7 percent.
• Organic matter, including blood, does not significantly reduce the effectiveness of 4% CHG solution.
• The solution very effectively removes debris from the site.

Stay tuned
Right now, facilities are on their own when it comes to choosing a prep (see "How to Select a Patient Skin Prep Solution for Your OR" on the next page). It may be that the picture will become clearer if and when the FDA approves a final monograph this summer.

1. Fowler, et al, American Association of Pharmaceutical Sciences, Nov. 1998.
2. Block, Disinfection, Sterilization and Preservation. 4th Edition, Philadelphia, Lea and Febinger, p. 279