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ChloraPrep™

Leading the way in effective pre-op skin prep

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About ChloraPrep™

ChloraPrep™ patient preoperative skin preparation is a rapid-acting, persistent and broad spectrum antiseptic for a wide range of procedures.

The ChloraPrep™ formulation is the only antiseptic formulation whose persistent anti-microbial power has been confirmed in study after clinical study.

In fact, with more than 50 studies confirming why it belongs in every OR, ChloraPrep™ has been studied more than any other skin antiseptic brand.

University Health, Georgia Testimonial Video

Partnering with University Health, Georgia, we implemented ChloraPrep™ solutions to standardize processes and reduce variability to enhance outcomes, patient safety and surgical success. This video will show you how.

Related products

Overview

ChloraPrep™ patient preoperative skin preparation products

Skin prep you can trust.

The only 2% CHG / 70% IPA solution with > 50 clinical studies supporting its efficacy and safety; setting the standard of care in infection prevention for over 18 years.

About

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

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

Below you can see the various traits of common antimicrobial agents used today.

Comparison of antimicrobial agents

Active agents
Traditional iodophors
Alcohol
Chlorhexidine*

Broad spectrum 

 X

X

X

Rapid bactericidal activity 

 

X

 

Residual activity 

 

 

X

Activity in blood/organic matter 

   

X

Non/Minimal absorption 

   

X

The 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.

The unique dual formulation offered by ChloraPrep™ skin preparation has been shown to outperform iodine-based products. 1,2,3

Proven Formulation

ChloraPrep™ is the only formulation whose persistent antimicrobial power was confirmed in study after clinical study. With a well-documented history in clinical practice, ChloraPrep™ skin preparation appears in Level I evidence based studies. In fact, the unique N% CHG and 70% IPA ChloraPrep™ formulation appears in more than 50 peer-reviewed publications.

“… 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

The Recommendations are Clear

ChloraPrep™ meets third party evidence-based standards for preoperative skin antisepsis according to leading healthcare organizations. 4,5,6

Comparison of antimicrobial agents

Active agents
Traditional iodophors
Alcohol

2016

World Health Organization (WHO) 4

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

2016

American College of Surgeons and Surgical Infection Society 5

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

2017

Centers for Disease Control and Prevention(CDC)6

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

Notes

* ChloraPrep patient preoperative skin preparation active agent

ChloraPrep™ formulation FAQs

A rapid-acting and persistent preoperative skin preparation. Its proven formulation is available in six unique applicators designed for procedures ranging from peripheral IV insertion to major surgery.

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

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

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.

ChloraPrep™ preoperative skin preparation meets the Centers for Disease Control and Prevention (CDC) Guidelines for the Prevention of Intravascular Catheter-Related Infections, published in 2002. The guidelines state to "clean skin with a > 0.5% chlorhexidine preparation with alcohol before central venous catheter and peripheral arterial catheter."

The use of a 2% chlorhexidine-based preparation for cutaneous antisepsis is classified as a Category 1A recommendation—the highest level of recommendation the Centers for Disease Control and Prevention (CDC) bestows. A Category 1A recommendation is clean skin with a > 0.5% chlorhexidine preparation with alcohol before central venous catheter and peripheral arterial catheter.

The tint process for 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 Orange 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 ChloraPrep™ formulation, which offers proven, stable and uncompromised chlorhexidine-based solutions.

Yes. Chlorhexidine gluconate is highly recommended by at least 18 organizations and initiatives, with 11 specifically advocating a 2% formulation.

Scientific and clinical support of 2% CHG and 70% IPA

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. CHG maintains antimicrobial activity, demonstrating 2 log10 and 3 log10 for at least 48 hours1,2 compared to two hours for free iodine.3 Because ChloraPrep™ preoperative skin preparation contains the combination of isopropyl alcohol and chlorhexidine, it is more effective than isopropyl alcohol alone.

Advantages of ChloraPrep™ preoperative skin preparation include its broad spectrum, rapid-acting and persistent antimicrobial activity (48 hours) and effectiveness in the presence of blood and organic matter. These advantages are a result of the unique 2% CHG/70% IPA formulation of 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, ChloraPrep™ preoperative skin preparation provides better broad spectrum, immediate, cumulative and residual antibacterial activity compared to traditional iodophors.

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.4

Yes. Chlorhexidine-based antiseptics have been used globally for more than 50 years and have been widely used in Europe, Canada and Japan for more than 30 years. In the United States alone, more than 100 studies (excluding those focused on hygiene data) have been published, revealing positive outcomes related to the use of chlorhexidine gluconate (CHG)-based antiseptics. Studies that used ChloraPrep preoperative skin preparation specifically represent close to 25% of the published CHG data in the healthcare setting.

Yes. A prospective blood culture study showed CHG was highly effective in reducing the contamination rate of blood cultures. The rate of blood culture contamination was lowered to 0.5% (1 of 215 cultures) with CHG.5 Another blood culture study found that tincture of iodine yielded a slightly higher contamination rate than chlorhexidine. In addition, iodine tincture has the disadvantage of being toxic when used repeatedly, while toxicity was found to be very uncommon with chlorhexidine.6

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.7

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.4

Using ChloraPrepTM  preoperative skin preparation

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

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

ChloraPrepTM  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.

ChloraPrepTM  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  ChloraPrepTM 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.

Yes. ChloraPrepTM  preoperative skin preparation has been tested in a surgical setting measuring bacterial colonization-reduction comparisons among preoperative skin preparations. Clinical outcomes concluded that ChloraPrepTM  preoperative skin preparation was the most effective solution for eliminating potential wound contaminants from the forefoot prior to surgery.9

At the Invasive Heart Lab of Aultman Hospital in Canton, Ohio, ChloraPrepTM  preoperative skin preparation was part of three evidence-based improvements put in place to reduce the risk of infections related to pacemakers and implantable cardioverter-defibrillators (ICDs). These evidence-based improvements and focus on heart lab protocols yielded dramatic results. For 22 months, the intensive heart lab had no infections—a 0% infection rate. "By adhering to key evidence-based standards and protocols, we are protecting our patients from avoidable infections." –Beth A. Taylor RN, BC, CVNII10

ChloraPrepTM applicators and tints

ChloraPrepTM  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 ChloraPrepTM  swabstick and the patented glass ampule in the Frepp3 mL, 10.5 mL and 26 mL applicators eliminate the risk of contaminated solution and protect the chlorhexidine gluconate (CHG) molecule from degradation.

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

Each ChloraPrepTM  applicator offers a number of unique benefits to preoperative skin preparation. 

It is recommended that ChloraPrepTM  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 ChloraPrepTM  tints, they can be removed with a ChloraPrepTM  clear applicator, alcohol, or soap and water.

The coverage area is specific to each applicator. 

  • 26 mL BD ChloraPrep applicator: ~13.2 inches x ~13.2 inches
  • 10.5 mL BD ChloraPrep applicator: ~8.4 inches x ~8.4 inches
  • 3 mL BD ChloraPrep applicator: ~4 inches x ~5 inches
  • 1mL and FREPP 1.5 mL BD ChloraPrep applicators and ChloraPrep swabstick: ~2.5 inches x ~2.5 inches

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

Customer support

Yes. The full line of ChloraPrepTM  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 ChloraPrepTM  preoperative skin preparation in your current SPT/CPT kits.

Yes. To request samples, contact ChloraPrepTM  Customer Support at 800.523.0502 ext. 3576.

About

Overview

Patient skin preparation product labels updated based on FDA recommendations

The U.S. Food and Drug Administration (FDA) has requested that companies voluntarily make updates to their skin antiseptic products.


This request was the result of infrequent reports of infections caused by contaminated skin preparation products.

In response to this industry-wide request initiated by the FDA, BD updated the labels on its ChloraPrep™ patient preoperative skin preparation portfolio in March 2015. We are now updating the remainder of the skin preparation product portfolio labels with information intended to ensure continued clinician education and patient safety.

BD is in the process of updating its product labels by:

  • Adding the phrase "non-sterile solution" on the label of all products indicated for preoperative skin prep
  • Including the phrase "single-use" for all products indicated for preoperative skin preps
  • Removing the phrase "patient preoperative skin preparation" or "preinjection skin preparation" on multiple-use containers

About

The same antisepsis solution

Our skin preparation products have not changed in any way and continue to be a broad portfolio of antiseptic solutions.


For a full list of the affected products, see the enclosed file and its chart of products and their associated updates.

About

ChloraPrep™ labels

Properly use ChloraPrep™ surgical skin preparation solutions by following label information


These labels are provided to help you properly use ChloraPrep products.

See the labels »

View the FAQs »

More Information

Questions

For more information, contact your sales representative or Customer Support at 800.323.9088.

Awards

The AORN Seal of Recognition was awarded to the CareFusion CHP label change program on February 20, 2015, and does not imply that AORN approves or endorses any product or service mentioned in any presentation, format or content. The AORN Recognition program is separate from the AORN, ANCC Accredited Provider Unit and therefore does not include any CE credit for programs.

Reference

This information only pertains to U.S. solutions.

  1. Garcia, R., Mulberry, G., Brady, A., Hibbard, J. "Comparison of ChloraPrep and Betadine Gas preoperative skin preparation antiseptics." Poster presented at the 40th Annual Meeting of the Infectious Disease Society of America, October 25, 2002.

  2. Crosby, C., Mares, A. Skin antisepsis: past, present and future. J Vasc Access Devices, Spring 2001, 26–31.

  3. Denton, Graham. "Chlorhexidine." In: Block, S., editor. Disinfection, Sterilization and Preservation, 5th Edition. Philadelphia: Lippincott, Williams & Wilkins, 2001, 321–336.

  4. Trautner, B. Skin antisepsis kits containing alcohol and chlorhexidine gluconate or tincture of iodine are associated with low rates of blood culture contamination. Infection Control and Hospital Epidemiology, 2002.

  5. Barenfanger, J. Comparison of chlorhexidine and tincture of iodine for skin antisepsis in preparation for blood sample collection. Journal of Clinical Microbiology, 2004, 2216–2217.

  6. Chawner, J., Gilbert, P. Interaction of the bisbiguanides chlorhexidine and alexidine with phospholipid vesicles: evidence for separate modes of action. J Appl Bacteriol, March 1989, 66(3):253–258.

  7. O'Grady, N., Alexander, M., Dellinger, E. et al. Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention. MMWR Recomm Rep, 2002, 51(RR-10):1–29.

  8. Ostrander, R., Botte, M., Brage, M. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am, 2005, 87(5):980–985.

  9. Taylor, B. Putting better research into practice; cutting surgical site infection rates for pacemakers and ICDs. Nursing, 2006, 36(3).

  10. Brown, E., Wenzel, R., Hendley, J. Exploration of the microbial anatomy of normal human skin by using plasmid profiles of coagulase-negative staphylococci: search for the reservoir of resident skin flora. J Infect Dis, 1989, 160:644–650

                                                                                                                                           

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