"Nowadays, surgery centers are looking for everything they need in one quick step. Bing-bang-boom, and you're done in 30 seconds," notes Michelle Gast, Product Manager for Allegiance, maker of Prevail-Fx.
These products range from "new and improved" versions of povidone-iodine (PVP-I), the active ingredient in Betadine, to antimicrobials that are either new or new to the US. In many cases, they are said to offer significant advantages in what they kill, how fast they kill it, and how long they remain active at the surgical site.
Here is an overview of these products and how they might make patient and staff prepping safer, faster, and more effective.
Prevail-Fx is a combination of PVP-I and isopropyl alcohol, delivered in a single-use package with a flow-controlled applicator. PVP-I provides a 99.99 percent bacterial kill in 15 seconds, takes 30 seconds to apply, and the alcohol ensures a quick drying time. The applicator and package eliminate the need for swabs, as well as the contamination risk of multi-use bottles.
"Patient skin preparations have traditionally been performed using PVP-I, which many know and refer to as ?Betadine.' This traditional method involves prepping with a 7.5% PVP-I scrub, followed by a 10% PVP-I paint. The process of scrubbing , blotting, scrubbing again, blotting again, and then painting is effective, but can be messy, more cumbersome, and takes five to 10 minutes," notes Ms. Gast.
To save drying time, surgical staff have been known to apply PVP-I, and then blot it. Prevail-Fx dries quickly by itself and provides a residual effect for over 24 hours.
Prevail-Fx solution follows Prevail gel into the marketplace. Prevail gel came out in 1998, and was developed to compete with Dura-Prep, the first one-step prep solution from 3M, which came out in 1987. Ms. Gast says the Prevail products differ from DuraPrep in several ways. First, the film formed by both Prevail-Fx and Prevail can be removed post-operatively with soap and water. Both products also maintain some level of solubility, which Ms. Gast believes is imperative to the release of bacteria-killing free iodine.
Prevail is a gel rather than a solution. With its greater viscosity, it won't run or pool at the surgical site. Prevail-Fx is a solution, which offers advantages of its own. According to Ms. Gast, it contains water-resistant polymers (much like waterproof mascara), making it good for fluid-intensive procedures such as orthopedics. It also offers better drape adhesion and a slightly quicker drying time than the gel.
Chlora-Prep One-Step is a combination of 2% chlorhexidine gluconate and 70% isopropyl alcohol delivered with a single-use applicator. This product has been used for many years in other parts of the world, but was only recently approved by the FDA for US use.
"Although PVP-I and alcohol are considered drugs, these products were ?grandfathered' into the Tentative Final Monograph for Healthcare Antiseptics and did not require the rigorous testing required for healthcare antiseptics," notes Cynthia Crosby, director of clinical marketing for Medi-Flex, Chlora-Prep's manufacturer.
In addition, many of the companies in this niche of the pharmaceutical industry are small, and lacked the resources to bring chlorhexidne to market. Says Ms. Crosby, "It costs a tremendous amount of money to sponsor FDA trials and conduct the required evaluations, but on this type of drug product, you only get pennies on the dollar as the return on your investment."
When the research was conducted, it revealed good news about chlorhexidine:
- The combination of chlorhexidine and alcohol offers a "quick kill" and fast drying by the alcohol, and a long residual effect with chlorhexidine.
- Studies that compared the performance of chlorhexidine to PVP-I or alcohol in preventing catheter-related infections showed that chlorhexidine had the lowest incidence of infections.
- Chlorhexidine is effective as a pre-op scrub or a handwash for perioperative staff. Several studies showed significant reductions in hospital-acquired infections when chlorhexidine was used.
- Safety studies show that chlorhexidine cannot be absorbed through the skin, and that accidental ingestion is only a problem in large amounts.
- A study of skin irritation, comparing chlorhexidine with normal saline, PVP-I, and other antimicrobials, showed that chlorhexidine was less irritating than PVP-I. When placed under a plain gauze dressing, chlorhexidine's irritation capacity "was not significantly greater than that of normal saline."
The bad news is the cost. While prepping with Betadine will cost 35 to 40 cents per case, prepping with Chlora-Prep will cost 85 cents per case. However, Ms. Crosby says the cost is offset by its ability to prevent infections.
"Just one case of infection can cost $3,000 to $30,000 in extra treatment cost. Chlora-Prep will cost more initially, but it will pay for itself thousands of times over if, with its use, a facility can prevent just one case of catheter-related bloodstream infection," Ms. Crosby says.
Persist Plus is another chlorhexidine surgical prep product. It's not on the market yet, but it has received "fast-track" status from the FDA. Persist Plus is currently sold in Canada and Australia.
Although it has the same active ingredient as Chlora-Prep, Persist Plus is "extremely different," says Keri Hunsicker, product manager for antimicrobials for Becton-Dickinson. Persist Plus contains a chemical barrier that suspends the chlorhexidine, extending the residual "kill time."
Persist Plus is a second-generation form of Persist, which came on the market about five years ago. Persist is sold in packets containing swabs impregnated with the liquid. It is not marketed as a surgical prep, but as a convenient and effective prep for drawing blood or inserting a catheter.
While Ms. Hunsicker expects the use of chlorhexidine for surgical prep to increase, she predicts the market will have room for both chlorhexidine and PVP-I.
"You can assume chlorhexidine products will be more expensive (than PVP-I) because of the expense of bringing them to market," she notes. "And not everyone will need chlorhexidine, which is best for insertion of catheters and ports, and higher-risk patients."
Techni-Care is a surgical prep product based on a newer chemical technology than either PVP-I or chlorhexidine. The active ingredient is PCMX, which is a man-made phenolic, Para-chlor-meta-xylenol. It also contains a phospholipid, collagen, aloe and a humectant, which makes this antimcrobial product very gentle to the skin.
"Techni-Care has a proven kill time of 30 seconds, and it's the only surgical prep product that doesn't contain alcohol. The big problem with alcohol-based products is that they don't contain surfactants, so you need a separate cleaning and de-greasing product. Techni-Care does it all," notes Sherry Brereton, VP of Sales and Marketing for Techni-Care's maker, CareTech.
Some of the product's unusual features include:
- It can be used as a surgical scrub as well as a surgical prep. It has been used therapeutically by surgical personnel to heal hands that are raw and irritated from using other scrub products.
- It is non-staining, as well as being non-irritating to the skin, helping boost its use in Plastics.
- Techni-Care can be used on mucous membranes, so it has gained popularity in Ob-Gyn. It has been tested in Eyetex Screen, a computer simulation of the membranes in the human eye. Techni-Care received a test rating of "minimal to mild" in ocular irritation, a score lower than that of baby shampoo.
- The product is the only non-toxic microbicide.
- Clinical studies at the University of Minnesota and University of Pittsburgh Medical School showed that Techi-Care works as a topical microbicide on open wounds.
As with other one-step prep products, Techni-Care costs more than Betadine. Because Techni-Care is a gel, however, the user needs to apply just one-fifth the amount needed for solutions such as PVP-I.
Techni-Care is not new, having been introduced a decade ago. Ms. Brereton says the product faced a good deal of initial resistance from nurses and doctors who only knew PVP-I.
"We encountered an extreme educational challenge. We've held programs at numerous professional meetings, and we've completed med-school clinicals on Techni-Care," Ms. Brereton says.
In the past four years, use of the product has grown rapidly, with sales increases of 100 percent a month during that time, she notes: "Techni-Care is growing in all segments of health care. We've had great acceptance with plastics and Ob-GYN. Next we'll be presenting to orthopedics."
An orthopedic study in foot and ankle surgery is underway at UC-San Diego.
Actiprep is a surgical prep based on Trizenol, which is comprised of three key elements: alcohol, emollients and the preservative zinc pyrithione to prolong the effect of alcohol. Its maker, HealthPoint, says it's faster-acting and more persistent than PVP-I or chlorhexidine.
"Actiprep is virucidal and is very effective against multi-drug resistant organisms," notes HealthPoint's Shawn Gentry.
This product requires one uniformly-thin application with a disposable sponge. Total time for application and drying is less than two minutes. In a video comparison with the traditional PVP-I prep, Actiprep saved about 12 minutes per procedure, amounting to a savings of one hour for five procedures. The orange-colored prep contains a film-former that helps drapes stick to the operative site, yet can be removed easily with soap and water.
Right now, the product is sold in a kit or in 4-oz. bottles. In the fall, HealthPoint will introduce a one-step delivery device for use with Actiprep.
HealthPoint also makes Triseptin, a brush-free surgical scrub, also based on Trizenol. The company says it will launch three more Trizenol-based products in the coming months.
"Trizenol technology has been chemically formulated to meet the needs of today's surgical environment, and these products have demonstrated superior efficacy compared to chemical technology currently used in the skin asepsis marketplace," says Ms. Gentry. "As one can imagine, this is just the beginning for Trizenol."