BD ChloraPrep™ Patient Preoperative Skin Preparation

ChloraPrep Family straight -907x478" />

BD ChloraPrep™ patient preoperative skin preparation delivers standardized, powerful, persistent antimicrobial protection that is backed by more than 60 clinical studies and trusted by healthcare providers for more than 21 years. In a recent clinical study, BD ChloraPrep™ preoperative skin antiseptic demonstrated antimicrobial persistence for at least 7 days.¹

BD ChloraPrep™ with Sterile Solution has a full portfolio of products to meet the coverage area needs of each patient: 1mL, Frepp™ 1.5 mL, 3mL, 10.5 mL, and 26 mL sizes.

Beausoleil C, Comstock SL, Werner D, Li L, Eby JM, Zook EC. Antimicrobial persistence of two alcoholic preoperative skin preparation solutions. J Hosp Infect. 2022 Nov;129:8-16.

BD ChloraPrep™ patient preoperative skin preparation with sterile solution delivers standardized, powerful, persistent antimicrobial protection that is backed by more than 60 clinical studies and trusted by healthcare providers for more than 21 years. In a recent clinical study, BD ChloraPrep™ preoperative skin antiseptic demonstrated antimicrobial persistence for at least 7 days.¹ BD ChloraPrep™ skin prep products deliver the unmatched experience of nearly 5 billion applicators sold in 38 countries with unparalleled evidence supporting efficacy and safety.²

BD ChloraPrep™ applicators with Sterile Solution has a full portfolio of products to meet the coverage area needs of each patient: 1mL, Frepp™ 1.5 mL, 3mL, 10.5 mL, and 26 mL sizes.

Sterile Applicator and Solution

Patented sterilization technology maintains the efficacy and purity of the antiseptic solution.³

Maintaining lower levels of bacteria on the skin while healing is important to minimize bacteria entering the incision site or skin break. In a recent clinical study, BD ChloraPrep™ skin antiseptic demonstrated antimicrobial persistence for at least 7 days.¹

Standardized Processes and Cost Savings

BD ChloraPrep™ skin preparation is the only skin prep that offers a wide range of coverage areas to fit your clinical needs and allows for cost-saving standardized skin prep across care settings. Choose from a range of product options to fit your needs – and the color of your patient’s skin tone. Use Hi-Lite™ orange for lighter pigmented skin, Scrub Teal™ for darker pigmented skin, or clear when you want a colorless effect.

Surgical Portfolio of Fully Sterile Alcohol-Based Skin Antiseptics

BD ChloraPrep™ skin prep for your surgical skin antisepsis and BD PurPrep™ skin prep, an effective alternative when chlorhexidine plus alcohol is not indicated.

1. Beausoleil C, Comstock SL, Werner D, Li L, Eby JM, Zook EC. Antimicrobial persistence of two alcoholic preoperative skin preparation solutions. J Hosp Infect. 2022 Nov;129:8-16.

3. Degala, et al. United States Patent 9,078,934. July 14, 2015.

Leading the way in effective pre-op skin prep solutions and setting the standard of care in surgical infection prevention

ChloraPrep™ is the first antiseptic solution with a 2% chlorhexidine gluconate (CHG) / 70% isopropyl alcohol (IPA) formulation and provides distinct advantages over other products in how to prepare for surgery.

How does your current antiseptic solution compare?

Feature	BD ChloraPrep™	Other Antiseptics	BD ChloraPrep™ value
Formulation			Proven broad spectrum, rapid acting antiseptic combination of 2% CHG and 70% IPA with the option for tint. The formulation contains no additional excipients.
Available Sizes			Vascular and Surgical sizes for consistency in prepping processes.
Sterile Applicators with Sterile Solution			Less than 1 in a million chance that a viable microorganism can exist in the solution. 1
Persistence			At least 7 days. 2
Studies & Independent Data			Supported by more than 60 published peer-reviewed clinical studies.
Tint Options			Hi-Lite Orange™, Scrub Teal™, and clear for different skin tones.
Acting in the presence of organic matter			Not neutralized by blood or organic matter. 3

The BD ChloraPrep™ formulation uses a combination of chlorhexidine and isopropyl alcohol to provide both rapid killing of bacteria and persistent antimicrobial activity.

IPA rapidly kills microorganisms by denaturing cell proteins, while CHG maintains persistent antimicrobial activity by disrupting the cell membrane and precipitating cell contents. Additionally, CHG is able to bind to the skin and retain antimicrobial activity in the presence of blood and other organic material.

BD ChloraPrep™ patient preoperative skin preparation delivers standardized, powerful, persistent antimicrobial protection that is backed by more than 60 clinical studies and trusted by healthcare providers for more than 21 years. In a recent clinical study, BD ChloraPrep™ preoperative skin antiseptic demonstrated antimicrobial persistence for at least 7 days.¹

“… because the efficacy of any formulation is significantly affected by the excipients present, trials demonstrating activity of one formulation can not be used as evidence for the efficacy of another.”

-Graham W. Denton

Denton G., Chlorhexdine. In: Block S, ed. Disinfection, Sterilisation and Preservation. 5th ed. Lippincott Williams and Wilkins. 2001

BD ChloraPrep™ meets third party evidence-based standards for preoperative skin antiseptic solutions according to leading healthcare organizations. _4,5,6

Comparison of antimicrobial agents

Active agents

Traditional iodophors

Alcohol

World Health Organization (WHO) 4

The panel recommends alcohol-based antiseptic solutions based on CHG for surgical skin site preparation.

American College of Surgeons and Surgical Infection Society 5

Alcohol-containing preoperative skin preparatory agents should be used unless contraindication exists.

Centers for Disease Control and Prevention(CDC) 6

Perform intraoperative skin preparation withan alcohol-based antiseptic agent unless contraindicated.

1. Degala, et al. United States Patent 9,078,934. July 14, 2015

2. Beausoleil C, Comstock SL, Werner D, Li L, Eby JM, Zook EC. Antimicrobial persistence of two alcoholic preoperative skin preparation solutions. J Hosp Infect. 2022 Nov;129:8-16

3. Mimoz, O et al. Chlorhexidine compared with povidone-iodine as skin preparation before blood culture. A randomized, controlled trial. Annals of internal medicine vol. 131,11 (1999): 834-7

4. WHO 2016 Global guidelines for the prevention of SSIs fact sheet https://cdn.who.int/media/docs/default-source/integrated-health-services-(ihs)/ssi/fact-sheet-skin-web.pdf?

5. Ban KA, Minei JP, Laronga C, Harbrecht BG, Jensen EH, Fry DE, Itani KM, Dellinger EP, Ko CY, Duane TM. American College of Surgeons and Surgical Infection Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2017 Jan;224(1):59-74

6. Berríos-Torres SI, et al; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791.

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 antiseptic 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

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.

How is receiving FDA approval for an NDA different from meeting the requirements of the FDA tentative final monograph for topical antimicrobial drug products for over-the-counter human use?

When seeking Food and Drug Administration (FDA) approval for an over-the-counter antiseptic, all manufacturers of chlorhexidine-based solutions are required to submit a new drug application (NDA). The review of a NDA by the FDA includes evaluation of clinical, manufacturing and labeling information to assure the product is safe and effective.

Alcohol and iodophors were identified by the FDA as "generally recognized as safe and effective" (GRASE) and are included in the tentative final monograph from the FDA. As a result, manufacturers of alcohol, iodophors and iodine-based solutions can market products without submitting efficacy and safety data and product labeling to the FDA for review prior to marketing and selling their products.

Prepping time varies by the location and size of the prep site and applicator used.

• Hold the applicator with the sponge down.

• Pinch the lever only once to activate the ampules and release the antiseptic.

• Wet the sponge by pressing and releasing the sponge against the treatment/

incision area until liquid is visible on the skin.

• Completely wet the treatment area with antiseptic.

Dry surgical sites (e.g., abdomen or arm)

– Use gentle, repeated back-and-forth strokes for 30 seconds.

Moist surgical sites (e.g., inguinal fold)

– Use gentle, repeated back-and-forth strokes for 2 minutes.

• Do not allow the solution to pool; tuck prep towels to absorb solution, and then remove.

• For safety and efficacy, allow the solution to completely dry. Follow labeled instructions per applicator package.

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.
• 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:

• The Antiseptic 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 antiseptic 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 antiseptic 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 antiseptic 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)

BD ChloraPrep™ applicators have been designed as convenient single-use, latex-free, hands-off applicators. Designed for a smooth delivery of the appropriate amount of solution for each respective procedure, the packaging for the BD ChloraPrep™ swabstick and the patented glass ampule in the Frepp™, 3 mL, 10.5 mL and 26 mL applicators eliminate the risk of contaminated solution and protect the chlorhexidine gluconate (CHG) molecule from degradation.

Furthermore, BD ChloraPrep™ Frepp™, 3 mL, 10.5 mL and 26 mL applicators each use a patented "wing" design to minimize instances where aseptic technique is compromised.

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

BD ChloraPrep™ products are labeled with a three-year shelf life from the date of production.

Yes. The full line of BD ChloraPrep™ applicators is available in a wide range of kits and trays. Our trained customer support representatives can work with your facility kit manufacturers to include BD ChloraPrep™ preoperative skin preparation in your current SPT/CPT kits.

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

For most SSIs, the source of pathogens is the endogenous flora of the patient’s skin, mucous membranes, or hollow viscera. When mucous membranes or skin is incised, the exposed tissues are at risk for contamination with endogenous flora.⁴ The goal of preoperative patient skin antisepsis is to reduce the patient's risk of developing a surgical site infection by removing soil and transient microorganisms at the surgical site. Reducing the amount of bacteria on the skin near the surgical Incision lowers the risk of contaminating the surgical incision site. Effective skin antiseptics rapidly and persistently remove transient microorganisms and reduce resident microorganisms to sub-pathogenic levels with minimal skin and tissue irritation.⁵

Surgical skin preparation aims to reduce the bacteria on the skin that may cause infection through the cleaning of the patient’s skin.⁶

Clipping hair before surgery isn’t just messy—the loose hair can increase the potential risk of contamination to your patients. Potentially contaminated hair on linens, wheels and the floor can migrate into the OR and elsewhere in the facility.

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

Alcohol-based preoperative skin antiseptic solutions 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

A comparison of patient preoperative skin antiseptic solutions

○ 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

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.