BD ChloraPrep™ Applicators with Sterile Solution

BD ChloraPrep™ is a rapid-acting and persistent preoperative skin preparation. Its proven formulation is available in six unique applicators designed for the right amount of solution for the right procedural area.

Advantages of BD ChloraPrep™ preoperative skin preparation include its broad spectrum, rapid-acting and persistent antimicrobial activity (at least 7 days¹), and effectiveness in the presence of blood and organic matter. These advantages are a result of the unique 2% CHG/70% IPA formulation of BD ChloraPrep™ preoperative skin preparation. Chlorhexidine gluconate, a cationic bisbiguanide, works by destroying the bacterial cell membrane and precipitating cell contents. Alcohol denatures cell proteins. As a result, BD ChloraPrep™ preoperative skin preparation provides better broad spectrum, immediate, cumulative and residual antibacterial activity compared to traditional iodophors. ² ³

2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)

Yes. After submitting a new drug application (NDA) to the Food and Drug Administration (FDA), BD ChloraPrep™ preoperative skin preparation received FDA approval in 2000.

Prepping time varies by the location and size of the prep site and applicator. Prepping with BD ChloraPrep™ preoperative skin preparation is a procedure that, compared to the "scrub and paint technique," greatly reduces the amount of time required for patient preoperative skin preparation.

BD ChloraPrep™ preoperative skin preparation is for external use only.

Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

BD ChloraPrep™ should not be used:

• On patients with known allergies to chlorhexidine gluconate or isopropyl alcohol
• For lumbar puncture or in contact with the meninges
• On open skin wounds or as a general skin cleanser
• In or around eyes, ears, and mouth. It may cause serious or permanent injury if it is permitted to enter and remain.

Additional labeled warnings of BD ChloraPrep™ preoperative skin preparation include:

• Solution contains alcohol and gives off flammable vapors—allow it to dry for three minutes on hairless skin.
• Do not drape or use an ignition source (e.g., cautery, laser) until the solution is completely dry (allow it to dry for a minimum of three minutes on hairless skin; up to one hour in hair).
• Avoid getting solution into hairy areas, as wet hair is flammable. Hair may take up to one hour to dry. Reduced dry time for smaller applicators.
• Do not allow the solution to pool.
• Remove any soaked materials, drapes and gowns before using ignition sources.
• Whenever prepping the neck area, place towels under each side to absorb excess solution and then remove.

Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Each BD ChloraPrep™ applicator is appropriate for a variety of procedures, depending on the size of the area that needs to be prepped.

26 mL BD ChloraPrep™ applicator (~13.2 in x ~13.2 in)

10.5 mL BD ChloraPrep™ applicator (~8.4 in x ~8.4 in)

3 mL BD ChloraPrep™ applicator (~4 in x ~5 in)

1 mL and FREPP™ 1.5 mL BD ChloraPrep™ applicators and ChloraPrep™ swabstick (~2.5 in x ~2.5 in)

The tint process for BD ChloraPrep™ Scrub Teal™ and Hi-Lite Orange™ tints is a patented technology that adds color to the solution as it enters the sponge pad. When applied to the skin, each tint allows for easy visualization of the prepped area. Unlike iodine-based preps, which are brown, Scrub Teal™ and Hi-Lite Orange™ tints are easy to see when applied to a variety of skin tones. The dyes in Scrub Teal™ and Hi-Lite Orang™e tints are Food, Drug and Cosmetic (FD&C) Green #3 and Yellow #6 dyes, and have been "generally recognized as safe" (GRAS) by the Food and Drug Administration (FDA). For an ingredient to be listed as GRAS, extensive safety testing is conducted, reviewed and accepted. FD&C Green #3 is a common colorant used in many applications throughout the healthcare field (e.g., eye angiography and screening for ocular dryness, routine lab testing, dye injections, histological/cytological stains for cancer screening of tissues). FD&C Green #3 and Yellow #6 were found to be stable when combined with the 2% chlorhexidine gluconate/70% isopropyl alcohol BD ChloraPrep™ formulation, which offers proven, stable and uncompromised chlorhexidine-based solutions.

It is recommended that BD ChloraPrep™ preoperative skin preparation with tint remain on the skin, especially at the incision site, post-procedure to provide maximum antimicrobial activity. The tints will slowly fade from the skin. If your facility's policies or procedures require clean-up and/or removal of the BD ChloraPrep™ tints, they can be removed with a BD ChloraPrep™ clear applicator, alcohol, or soap and water.

The coverage area is specific to each applicator.

26 mL BD BD ChloraPrep™ applicator: ~13.2 inches x ~13.2 inches

10.5 mL BD BD ChloraPrep™ applicator: ~8.4 inches x ~8.4 inches

3 mL BD BD ChloraPrep™ applicator: ~4 inches x ~5 inches

1mL and FREPP 1.5 mL BD BD ChloraPrep™ applicators and BD ChloraPrep™ swabstick: ~2.5 inches x ~2.5 inches

The BD ChloraPrep™ single and triple swabstick applicators have a two-year shelf life from the date of production. All other BD ChloraPrep™ products are labeled with a three-year shelf life from the date of production.

Yes. To request samples, contact BD ChloraPrep™ Customer Support at 1.844.8.BD.LIFE (844.823.5433)

Preoperative skin preparation is necessary to limit microorganisms on the skin and help minimize their entry into an incision or device-insertion site after application. Normal skin flora and suboptimal skin antisepsis are the primary drivers of healthcare-associated infections (HAIs).¹

Cleaning the skin before surgery reduces the amount of bacteria and microorganisms present that may cause surgical site infections. Follow antiseptic package inserts for optimal efficacy with regards to following prep time, application process, dry time, and warnings/contraindications.

Alcohol-based preoperative skin antiseptics are recommended in the evidence-based infection prevention guidelines published by preeminent health organizations:

● American College of Surgeons/Surgical Infection Society (ACS/SIS): Alcohol-containing preoperative skin preparatory agents should be used unless contraindication exists. (2016)⁷

● Centers for Disease Control and Prevention (CDC): Perform intraoperative skin preparation with an alcohol-based antiseptic agent unless contraindicated. (2017)⁸

● World Health Organization (WHO): The panel recommends alcohol-based antiseptic solutions based on CHG for surgical skin site preparation.⁶

● Society for Healthcare Epidemiology of America (SHEA): Use an alcohol based antiseptic for skin preparation.⁹

○ PVP-I allows for the free iodine to be released, which destroys proteins and DNA of microorganisms.

○ This solution is often used, since it is safe to use on most skin regardless of age.

○ CHG breaks down bacteria cell membranes to disinfect the skin.

○ The combination of fast-acting and persistent antimicrobial activity is the key to an effective preoperative skin preparation. IPA alone provides a 99.99% reduction in bacteria, but it does not provide long-lasting microbial kill. BD ChloraPrep™ maintains antimicrobial activity, demonstrating persistence for at least 7 days¹ compared to two hours for free iodine. Because BD ChloraPrep™ preoperative skin preparation contains the combination of isopropyl alcohol and chlorhexidine, it is more effective than isopropyl alcohol alone.

○ The chlorhexidine bisbiguanide groupings associate strongly to exposed anionic sites on the cell wall and cell membrane, particularly acidic phospholipids and proteins, causing displacement of divalent cations (Ca2+ and Mg2+). Bridging adjacent phospholipids in the cell membrane will cause a loss of structural integrity, reduce membrane fluidity and allow leakage of cellular materials. ¹³

○ Bacterial cells are negatively charged, but in the presence of chlorhexidine, the bacterial cell is neutralized and the charge is reversed. The attraction of the cationic chlorhexidine molecule and the negatively charged bacterial cell contributes to a rapid rate of bacterial kill; surface charge reversal is secondary to cell death. ³

○ In contrast, traditional iodophors can take two to three minutes until the free release of iodine can occur. While the iodophor dries, free iodine becomes available. The iodine then attacks the bacterial cell and the oxidation of two sulfhydryl groups, resulting in the formation of a disulfide bond. The effectiveness of iodophors is ≤ three hours. Lastly, iodophors are neutralized in the presence of blood and organic matter and have greater irritation than the CHG solution. ¹⁴

○ Chlorhexidine-based antiseptics have been used globally for more than 50 years and have been widely used in the US, Europe, Canada and Japan for more than 30 years. In the United States alone, more than 100 studies (excluding those focused on hand hygiene data) have been published, revealing positive outcomes related to the use of chlorhexidine gluconate (CHG)-based antiseptics. There are over 60+ published studies specifically for BD ChloraPrep™ preoperative skin preparation.

The combination of fast-acting and long-lasting antimicrobial activity is the key to an effective preoperative skin preparation. IPA alone provides a 99.99% reduction in bacteria, but it does not provide long-lasting microbial kill. BD ChloraPrep™ maintains antimicrobial activity for at least 7 days¹ compared to two hours for free iodine.³ Because BD ChloraPrep™ preoperative skin preparation contains the combination of isopropyl alcohol and chlorhexidine, it is more effective than isopropyl alcohol alone.

There are a number of reasons why skin preparation prior to surgery matters. Effectively preparing the skin can reduce the microorganisms on the skin that may cause surgical site infections. Below are some of the risk factors:

● On a single square centimeter of skin, there can be as many as 10 million aerobic bacteria¹⁵

● 80% of microorganisms reside in the first five cell layers of the epidermis¹⁶

● Infection prevention measures have focused on asepsis of healthcare providers and the environment, but there is evidence about the role played by the patient's own skin⁸