BD ChloraPrep™ Sterile Solution delivers standardised, 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™ Sterile Solution demonstrated antimicrobial persistence for at least 7 days.¹
BD ChloraPrep™ Sterile Solution has a full portfolio of products to meet the coverage area needs of each patient: 3mL, 10.5 mL, and 26 mL sizes.
Skin Prep You Can Trust
The unmatched experience of nearly 5 billion applicators sold in 38 countries for over 21 years with the unparalleled evidence of 60+ clinical studies supporting efficacy and safety.
Sterile Applicator and Solution
Patented sterilisation technology maintains the efficacy and purity of the antiseptic solution
Persistent
Maintaining lower levels of bacteria on the skin while healing is important to minimise bacteria entering the incision site or skin break. In a recent clinical study, BD ChloraPrep™ Sterile Solution demonstrated antimicrobial persistence for at least 7 days.
Standardised Processes and Cost Savings
BD ChloraPrep™ Sterile Solution is the only skin prep that offers a wide range of coverage areas to fit your clinical needs and allows for cost-saving standardised skin prep across care settings.
ChloraPrep™ Sterile Solution 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.
| Feature | BD ChloraPrep™ Sterile Solution | Other Antiseptics | BD ChloraPrep™ Sterile Solution 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™ Sterile Solution 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™ Sterile Solution patient preoperative skin preparation delivers standardised, 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™ Sterile Solution 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™ Sterile Solution meets third party evidence-based standards for preoperative skin antisepsis according to leading healthcare organisations. 4,5,6
Active agents | Traditional iodophors | Alcohol |
|---|---|---|
2016 | World Health Organisation (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. |
BD ChloraPrep™ Sterile Solution 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™ Sterile Solution 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™ Sterile Solution 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™ Sterile Solution 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)
Prepping time varies by the location and size of the prep site and applicator used.
Pinch
• Hold the applicator with the sponge down.
• Pinch the lever only once to activate the ampules and release the antiseptic.
Apply
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.
Dry
• 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™ Sterile Solution 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™ Sterile Solution preoperative skin preparation is for external use only.
Do not use on babies less than 2 months old. These products may cause irritation or chemical burns.
Do not use if you are allergic (hypersensitive) to chlorhexidine gluconate, isopropyl alcohol or Sunset Yellow (E110).
Do not use near eyes or mucous membranes, as it may cause eye irritation, pain, hyperemia, impaired vision, chemical burn and eye injury. If it does get into the eyes or the mucous membranes, they should be washed quickly with plenty of water.
Do not use on open skin wounds, broken or damaged skin.
BD ChloraPrep™ Sterile Solution should not come into contact with neural tissues, such as meninges, spinal cord and brain tissues, or the middle ear.
Additional labeled warnings of BD ChloraPrep™ Sterile Solution preoperative skin preparation include
Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
Each BD ChloraPrep™ Sterile Solution applicator is appropriate for a variety of procedures, depending on the size of the area that needs to be prepped.
26 mL BD ChloraPrep™ Sterile Solution applicator: 50cm x 50cm
10.5 mL BD ChloraPrep™ Sterile Solution applicator: 25cm x 30cm
3 mL BD ChloraPrep™ Sterile Solution applicator: 15cm x 15cm
BD ChloraPrep™ Sterile Solution 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™ Sterile Solution and the patented glass ampule in the 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™ Sterile Solution 3 mL, 10.5 mL and 26 mL applicators each use a patented "wing" design to minimise instances where aseptic technique is compromised.
The tint process for BD ChloraPrep™ Sterile Solution Hi-Lite Orange™ tints is a patented technology that adds colour to the solution as it enters the sponge pad. When applied to the skin, each tint allows for easy visualisation of the prepped area. Unlike iodine-based preps, which are brown, Hi-Lite Orange™ tints are easy to see when applied to a variety of skin tones.
It is recommended that BD ChloraPrep™ Sterile Solution 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.
The coverage area is specific to each applicator.
26 mL BD BD ChloraPrep™ Sterile Solution applicator: 50cm x 50cm
10.5 mL BD BD ChloraPrep™ Sterile Solution applicator: 25cm x 30cm
3 mL BD BD ChloraPrep™ Sterile Solution applicator: 15cm x 15cm
BD ChloraPrep™ Sterile Solution products are labeled with a three-year shelf life from the date of production.
Preoperative skin preparation is necessary to limit microorganisms on the skin and help minimise 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 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 organisations:
● 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 Organisation (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™ Sterile Solution maintains antimicrobial activity, demonstrating persistence for at least 7 days¹ compared to two hours for free iodine. Because BD ChloraPrep™ Sterile Solution 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 neutralised 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 neutralised 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™ Sterile Solution 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™ Sterile Solution maintains antimicrobial activity for at least 7 days¹ compared to two hours for free iodine.³ Because BD ChloraPrep™ Sterile Solution 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
Skin preparation solutions designed to reduce microorganisms on the skin before surgical procedures may contribute to contamination when nonsterile antiseptic solutions are used. According to the FDA, intrinsic contamination “may occur during the manufacturing process”.¹⁷ Infections from intrinsic contamination of antiseptics have been well documented.¹⁸ ¹⁹ Because of intrinsic contamination risks, the FDA requested that manufacturers label topical antiseptic solutions as sterile or nonsterile.¹⁷ Sterilising the antiseptic solution during production can minimise potential intrinsic bacterial threats. However, most U.S. manufacturers of commercially available antiseptic skin preparations have not adopted this technologically challenging process. BD overcame this challenge, developing a patented process to sterilise antiseptic solutions within sealed containers to provide sterility assurance. In summary:
● Antiseptics do not self-sterilise²º
● All commonly used antiseptic agents have been linked to infection-causing contamination.¹⁹
● Outcomes associated with contaminated antiseptics may be underreported for a range of reasons.
○ Disposal of the contaminated product before infection is discovered¹⁸
○ Inconsistent contamination within the same product lot¹⁸
BD offers an exclusive portfolio of fully sterile skin prep applicator products.
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.
2. Hemani ML, Lepor H. Skin preparation for the prevention of surgical site infection: which agent is best? Rev Urol. 2009 Fall;11(4):190-5
3. Denton GW. Chlorhexidine. Disinfection, sterilisation, and preservation. (Edited by S.S. Block, 4th ed) Philadelphia: Lea & Feabiger. 1991. pp. 322–333.
4. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132
5. 2021 AORN Guidelines for Perioperative Practice: Patient Skin Antisepsis
6. 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?sfvrsn=ead06f37_2#:~:text=Surgical%20site%20skin%20preparation%20is,the%20operating%20room%20(OR).
7. 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
8. 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.
9. Yokoe DS,,et al; Society for Healthcare Epidemiology of America (SHEA). A compendium of strategies to prevent healthcare-associated infections in acute care hospitals: 2014 updates. Infect Control Hosp Epidemiol. 2014 Aug;35(8):967-77.
10. AORN. Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc.; 2013:75-89.
11. Galvin P. Am J Nurs. 2009;109(12):49-55. doi: 10.1097/01.NAJ.0000365187.47124.c0.
12. Karpanen TJ, et al. Antimicrob Agents Chemother. 2009;53(4):1717-1719. doi:10.1128/AAC.01289-08.
13. Gilbert, P. and Moore, L.E. (2005), Cationic antiseptics: diversity of action under a common epithet. Journal of Applied Microbiology, 99: 703-715
14. 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.
15. Chen YE, Tsao H. The skin microbiome: current perspectives and future challenges. J Am Acad Dermatol. 2013 Jul;69(1):143-55.
16. Hendley JO, Ashe KM. Antimicrob Agents Chemother 1991 627-31
17. https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-fda-requests-label-changes-and-single-use-packaging-some-over-counter-topical
18. Chang C, Furlong LA. Microbial stowaways in topical antiseptic products. NEngJMed. 2012;367;23:2170-2173. doi: 10.1056/NEJMp1212680.
19. Weber DJ, Rutala WA, Sickbert-Bennett EE. Outbreaks associated with contaminated antiseptics and disinfectants. Antimicrob Agents Chemother. 2007;51(12):4217-4224.
20. Berger SA. Pseudobacteremia due to contaminated alcohol swabs. J Clin Microbiol. 1983;18 (4): 974-975.
21. Edmiston CE Jr, Griggs RK, Tanner J, Spencer M, Seabrook GR, Leaper D. Perioperative hair removal in the 21st century: Utilizing an innovative vacuum-assisted technology to safely expedite hair removal before surgery. Am J Infect Control. 2016 Dec 1;44(12):1639-1644.
22. Redelmeier, DA, Livesley NJ. Adhesive tape and intravascular-catheter-associated infections. J Gen Intern Med. 1999;14(6):373-375
23. AORN. AORN Guidelines for Perioperative Practice. 2015. Retrieved on May 20, 2016 at https://www.aorn.org/guidelines
24. Data on File
25. 2009 WHO Hand Hygiene Guidelines
