What is ChloraPrep skin antiseptic?
Scientific and Clinical Support of 2% CHG and 70% IPA
ChloraPrep Applicators and Tints
Using ChloraPrep Skin Antiseptic
What is ChloraPrep skin antiseptic? Q. What is ChloraPrep skin antiseptic?
A. ChloraPrep skin antiseptic is 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.
Top Q. What are the active ingredients of ChloraPrep skin antiseptic?
A. The active ingredients in ChloraPrep skin antiseptic are chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v.
Top Q. Is ChloraPrep skin antiseptic FDA approved?
A. Yes. After submitting a New Drug Application (NDA) to the Food & Drug Administration, ChloraPrep skin antiseptic received FDA approval in 2000.
Top 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.
Top Q. Which CDC guidelines recommend the use of a 2% chlorhexidine solution for skin antisepsis?
A. ChloraPrep skin antiseptic 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."
Top 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."
Top 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®
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 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.
Top 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 18 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 skin antiseptic contains the combination of isopropyl alcohol and chlorhexidine, it is more effective than isopropyl alcohol alone.
Top Q. How does ChloraPrep skin antiseptic compare to traditional iodophors?
A. Advantages of ChloraPrep skin antiseptic 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 skin antiseptic. Chlorhexidine gluconate, a cationic bisbiguanide, works by destroying the bacterial cell membrane and precipitating cell contents. Alcohol denatures cell proteins. As a result, ChloraPrep skin antiseptic 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
Top 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 skin antiseptic specifically, represent close to 25% of the published CHG data in the healthcare setting.
Top Q. Can ChloraPrep skin antiseptic 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
Top Q. Can you explain the science of ChloraPrep skin antiseptic?
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
Top Q. What is the "central line bundle" for managing infections? What is the role of ChloraPrep skin antiseptic?
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
- 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 skin antiseptic plays a significant role in supporting the efficacy of the central line bundle.
ChloraPrep Applicators and Tints 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®
, 3 mL
, 10.5 mL
and 26 mL
applicators eliminate the risk of contaminated solution and protect the CHG molecule from degradation.
Furthermore, 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.
Top 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, 3 mL, 10.5 mL and 26 mL applicators, visit the Product Line Page
Top Q. How are the Scrub Teal and Hi-Lite Orange tints removed from the skin?
A. It is recommended that ChloraPrep skin antiseptic 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.
Top 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
Top 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 skin antiseptic 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
Top Q. How long does it take to prep a patient using ChloraPrep skin antiseptic? Is it less time than with other products?
A. Prepping time varies by the location and size of the prep site and applicator. Prepping with ChloraPrep skin antiseptic is a procedure that, compared to the "scrub and paint technique," greatly reduces the amount of time required for patient preoperative skin preparation.
Top Q. Is ChloraPrep skin antiseptic safe to use with all procedures?
A. ChloraPrep skin antiseptic 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 skin antiseptic include:
- Solution contains alcohol and gives off flammable vapors—allow to dry three minutes on hairless skin
- Do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of three minutes on hairless skin; up to 1 hour in hair)
- Avoid getting solution into hairy areas, as wet hair is flammable; Hair may take up to 1 hour to dry
- 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
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
Top Q. Why do the directions on the ChloraPrep skin antiseptic 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 skin antiseptic 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 skin antiseptic included in vivo studies that 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.
Top Q. Has ChloraPrep skin antiseptic been approved for use in small children?
A. ChloraPrep skin antiseptic is approved for patient preoperative skin preparation for children over 2 months of age.
Top Q. Do studies support the use of ChloraPrep skin antiseptic in a surgical setting?
A. Yes. ChloraPrep skin antiseptic has been tested in a surgical setting measuring bacterial colonization reduction comparisons among skin antiseptics. Clinical outcomes concluded, ChloraPrep skin antiseptic 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 skin antiseptic 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 skin antiseptic 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 skin antiseptic in your current SPT/CPT kits.
Top 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 800.523.0502 ext. 3576.