What is ChloraPrep?
- What is ChloraPrep?
- What are the active ingredients of ChloraPrep?
- Is ChloraPrep FDA approved?
- How is receiving FDA approval for a NDA different than meeting the requirements of the FDA Tentative Final Monograph for Topical Antimicrobial Drug Products for Over-the-Counter Human use?
- Which CDC guidelines recommend the use of a 2% chlorhexidine solution for skin antisepsis?
- What category of CDC recommendation does 2% CHG receive?
- Tell me about the ChloraPrep tints. Why are some applicators tinted, and are they safe?
- In addition to CDC guidelines, are there other evidence-based guidelines that recommend the use of skin antiseptics containing chlorhexidine?
Scientific and Clinical Support of 2% CHG and 70% IPA
- Why is the combination of 2% chlorhexidine gluconate (CHG) and 70% isopropyl alcohol (IPA) better than IPA alone?
- Have any hospitals implemented ChloraPrep as a “best practice?” What were the outcomes?
- How is ChloraPrep superior to traditional iodophors?
- Does clinical data support the use of chlorhexidine to help reduce the incidence of infection?
- Can ChloraPrep help reduce the risk of blood culture contamination?
- Can you explain the science of ChloraPrep?
- What is the “central line bundle” for managing infections? What is the role of ChloraPrep?
ChloraPrep Applicators and Tint
- What makes ChloraPrep applicators unique?
- What are the individual advantages of each ChloraPrep applicator?
- How are the Scrub Teal™ and Hi-Lite Orange® tints removed from the skin?
- What is the coverage area of each applicator?
- What is the shelf life of ChloraPrep products?
Using ChloraPrep
- How do I know which applicator to use for a certain procedure?
- How long does it take to prep a patient using ChloraPrep? Is it less time than with other products?
- Is ChloraPrep safe to use with all procedures?
- Why do the directions on the ChloraPrep label indicate that it should be applied in a back-and-forth direction?
- Has ChloraPrep been approved for use in small children?
- Do studies support the use of ChloraPrep in a surgical setting?
Customer Support
What is ChloraPrep®?
A. ChloraPrep is a rapid-acting and persistent preoperative skin preparation. Its superior formulation is available in six unique applicators designed for procedures ranging from peripheral IV insertion to major surgery.
Q. What are the active ingredients of ChloraPrep?
A. The active ingredients in ChloraPrep are chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v.
Q. Is ChloraPrep FDA approved?
A. Yes. After submitting a New Drug Application to the Food & Drug Administration, ChloraPrep received FDA approval in 2000.
Q. How is receiving FDA approval for a NDA different than meeting the requirements of the FDA Tentative Final Monograph for Topical Antimicrobial Drug Products for Over-the-Counter Human use?
A. When seeking 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 FDA includes evaluation of clinical, manufacturing and labeling information to assure the product is safe and effective.
Alcohol and iodophors were identified by 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.
Q. Which CDC guidelines recommend the use of a 2% chlorhexidine solution for skin antisepsis?
A. ChloraPrep meets the CDC’s Guidelines for the Prevention of Intravascular Catheter-related Infections, published in 2002. The guidelines state that "for cutaneous antisepsis a 2% chlorhexidine preparation is preferred."
Q. What category of CDC recommendation does 2% CHG receive?
A. The use of a 2% chlorhexidine-based preparation for cutaneous antisepsis is classified as a Category 1A recommendation — the highest level of recommendation the CDC bestows. A Category 1A recommendation is "strongly recommended for implementation, supported by well-designed experimental, clinical, or epidemiologic studies."
Q. Tell me about the ChloraPrep tints. Why are some applicators tinted, and are they safe?
A. The tint process for ChloraPrep Scrub Teal™ and Hi-Lite Orange™ 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 ChloraPrep tints are easy to see when applied to a variety of skin tones.
The dyes in ChloraPrep Scrub Teal and Hi-Lite Orange 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 superior, stable, and uncompromised chlorhexidine-based solutions.
Q. In addition to CDC guidelines, are there other evidence-based guidelines that recommend the use of skin antiseptics containing chlorhexidine?
A. Yes. Chlorhexidine gluconate is highly recommended by at least 17 organizations and initiatives, with 11 specifically advocating a 2% formulation. For a complete listing click here.
Scientific and Clinical Support of 2% CHG and 70% IPA
Q. Why is the combination of 2% chlorhexidine gluconate (CHG) and 70% isopropyl alcohol (IPA) better than IPA alone?
A. The combination of fast-acting and long-lasting antimicrobial activity is the key to an effective skin antiseptic. 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 contains the combination of isopropyl alcohol and chlorhexidine, it is superior to isopropyl alcohol alone.
Q. Have any hospitals implemented ChloraPrep as a “best practice?” What were the outcomes?
A. A number of hospitals have implemented the use of ChloraPrep as a “best practice” and have seen significant reductions in their number of healthcare-associated infections. The following hospitals have each published case studies, examining the impact of using ChloraPrep as part of a systems approach to infection control in their facilities. To access copies of actual success stories, click on any of the hospitals below.
- Lahey Clinic (Burlington, MA)
- St. John Hospital and Medical Center (Detroit, MI)
- Brookdale University Medical Center (Brooklyn, NY)
These hospitals are not affiliated with ChloraPrep or Enturia in any manner. These hopsitals do not sponsor or endorse ChloraPrep.
Q. How is ChloraPrep superior to traditional iodophors?
A. Advantages of ChloraPrep 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. Chlorhexidine gluconate, a cationic bisbiguanide, works by destroying the bacterial cell membrane and precipitating cell contents. Alcohol denatures cell proteins. As a result ChloraPrep 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
Q. Does clinical data support the use of chlorhexidine to help reduce the incidence of infection?
A. 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 CHG-based antiseptics. Studies that used ChloraPrep specifically represent close to 25% of the published CHG data in the healthcare setting.
Q. Can ChloraPrep help reduce the risk of blood culture contamination?
A. 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
Q. Can you explain the science of ChloraPrep?
A. 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
Q. What is the "central line bundle" for managing infections? What is the role of ChloraPrep?
A. The central line bundle is a grouping of evidence-based interventions for patients with intravascular central catheters. Studies have shown that when 2% CHG is used as part of a central line bundle, catheter-related infections can be reduced by 50%.8 The central line bundle has seven key components:8
- Education
- Hand hygiene
- Maximal barrier precautions upon insertion
- 2% chlorhexidine skin antisepsis
- Optimal catheter site selection, with subclavian vein as the preferred site for non-tunneled catheters
- Daily review of line necessity with prompt removal of unnecessary lines
- Use of coated catheters
Because the CDC prefers a 2% chlorhexidine-based preparation, the 2% chlorhexidine gluconate/70% isopropyl alcohol solution of ChloraPrep plays a significant role in supporting the efficacy of the central line bundle.
ChloraPrep Applicators and Tint
Q. What makes ChloraPrep applicators unique?
A. 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 Swabstick and the patented glass ampule in the Sepp®, Frepp®, 3mL, 10.5mL and 26mL eliminate the risk of contaminated solution and protect the CHG molecule from degradation.
Furthermore, ChloraPrep Frepp, 3mL, 10.5mL and 26mL each use a patented “wing” design to minimize instances where aseptic technique is compromised.
Q. What are the individual advantages of each ChloraPrep applicator?
A. Each ChloraPrep applicator offers a number of unique benefits to preoperative skin preparation. To learn more about the Sepp, Frepp, single and triple Swabstick, 3mL, 10.5mL and 26mL, visit the Product Line Page.
Q. How are the Scrub Teal™ and Hi-Lite Orange™ tints removed from the skin?
A. It is recommended that ChloraPrep 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 cleanup and/or removal of the ChloraPrep tints, they can be removed with a ChloraPrep clear applicator, alcohol or soap and water.
Q. What is the coverage area of each ChloraPrep applicator?
A. The coverage area is specific to each applicator. You can reference coverage area and the many other benefits of the full line of applicators at the ChloraPrep Product Line Page.
Q. What is the shelf life of ChloraPrep products?
A. 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.
Using ChloraPrep
Q. How do I know which applicator to use for a certain procedure?
A. Each ChloraPrep applicator is appropriate for a variety of procedures, depending on the size of the area that needs to be prepped. To review a list of common applicator procedures, go to the Product Line Page.
Q. How long does it take to prep a patient using ChloraPrep? Is it less time than with other products?
A. Prepping time varies by the location and size of the prep site and applicator. ChloraPrep is a procedure that, compared to the “scrub and paint technique,” greatly reduces the amount of time required for patient preoperative skin preparation.
Q. Is ChloraPrep Safe to use with all procedures?
A. ChloraPrep is for external use only.
ChloraPrep should not be used:
- in children less than two months of age because of the potential for excessive skin irritation and increased drug absorption
- 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. May cause serious or permanent injury if permitted to enter and remain
Additional labeled warnings of ChloraPrep include:
- Solution contains alcohol and gives off flammable vapors
- Do not drape or use ignition source (e.g., cautery, laser) until product is completely dry (minimum of three minutes on hairless skin)
- Avoid getting solution into hairy areas. Solution may take much longer to dry or may not dry completely
- 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
For additional information on Prevention of Fire in the operating room please visit the following Websites:
- AORN Guidance Document: Fire Prevention in the Operating Room
- NFPA accepts ASHE’s amendment to NFPA 99 on Alcohol Based Surgical Prep Solutions
Q. Why do the directions on the ChloraPrep label indicate that it should be applied in a back-and-forth direction?
A. Clinical testing has shown that the back-and-forth motion used to apply ChloraPrep supports the efficacy of the solution. Because 80% of transient skin flora resides in the first five cell layers of skin11, it is important to reach those lower layers and kill the bacteria dwelling further down. The skin contains many cracks and crevices where harmful bacteria reside. The back-and-forth action creates friction and helps drive the solution into crevices and lower layers, reaching more bacteria. Further, there is no published data to support the concentric circular application methodology.
The New Drug Application (NDA) approved by the FDA for ChloraPrep included in vivo studies which showed that a minimum 3 log10 reduction for 48 hours was achieved on moist sites, and a 2 log10 reduction for 24 hours was achieved on dry sites while using a friction (back-and-forth) scrub.
Q. Has ChloraPrep been approved for use in small children?
A. ChloraPrep is approved for patient preoperative skin preparation for children over 2 months of age.
Q. Do studies support the use of ChloraPrep in a surgical setting?
A. Yes. ChloraPrep has been tested in a surgical setting measuring bacterial colonization reduction comparisons among skin antiseptics. Clinical outcomes concluded, ChloraPrep 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, OH, ChloraPrep was part of three evidence-based improvements put in place to reduce the risk of infections related to pacemakers and 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’re protecting our patients from avoidable infections” — Beth A. Taylor RN, BC, CVNII 10
Customer Support
Q. Can I get ChloraPrep in a kit?
A. Yes. The full line of 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 ChloraPrep in your current SPT/CPT kits.
Q. Are samples of ChloraPrep products available?
A. Yes. Samples of all our ChloraPrep applicators are available. To request samples please contact ChloraPrep Customer Support at 1-800-523-0502 ext. 3576 or visit the Customer Support Page.
1 Garcia R, Mulberry G, Brady A, Hibbard JS. Comparison of ChloraPrep and Betadine as preoperative skin preparation antiseptics. Poster presented at: 40th Annual Meeting of the Infectious Disease Society of America; October 25, 2002.
2 Data on file. Enturia, Inc.
3 Crosby CT , Mares AK. Skin antisepsis: past, present, and future. J Vasc Access Devices. Spring 2001:26-31.
4 Denton GW. Chlorhexidine. In: Block SS. Disinfection, Sterilization, and Preservation. 5th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2001:321-336.
5 Trautner, BW. 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.
6 Barenfanger, J. Comparison of Chlorhexidine and Tincture of Iodine for Skin Antisepsis in Preparation for Blood Sample Collection. Journal of Clinical Microbiology. 2004, p. 2216-2217.
7 Chawner JA., Gilbert, P. Interaction of the bisbiguanides chlorhexidine and alexidine with phospholipid vesicles: evidence for separate modes of action. J Appl Bacteriol. 1989 Mar; 66(3):253-8.
8 O'Grady NP, Alexander M, Dellinger EP, et al. Guidelines for the prevention of intravascular catheter-related infections. Centers for Disease Control and Prevention. MMWR Recomm Rep. 51 2002:1-29.
9 Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005; 87(5):980 985.
10 Taylor, BA. Putting Better Research into Practice; Cutting Surgical-site Infection Rates for pacemakers and ICDs. Nursing 2006; 36(3).
11 Brown E, Wenzel RP, Hendley JO. 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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