Preoperative skin antisepsis is a critical part of reducing the bacteria on the skin that may cause infection prior to surgery. The most common products used in the United States include alcohols, chlorhexidine, iodine, and iodophors as either single-agent preps or in combination. There are important aspects to the safe and effective use of these products and challenges to the variability in applying these antiseptics correctly.
There are many factors to consider in the determination of which antiseptic to use for a particular patient. Becker’s interviewed Lena Pearson RN, BSN, MS, CNOR BD Associate Director for Medical Affairs, to provide some insights on this topic.
Question: What are some important considerations when choosing the right skin antiseptic for surgery?
Lena Pearson (LP): When selecting a skin antiseptic, the active ingredient should not be the only consideration. Several other factors need to be considered:
- Evidence – Published peer-reviewed randomized controlled trials are important to weigh the efficacy of an antiseptic in clinical practice.
- Safety – Review whether there is a history of safety with the use of the antiseptic, especially with more compromised patient populations.
- Supply – In a complex post COVID global economy, ensuring adequate supply capabilities is important.
- IFUs – It is important to note that different manufacturers may have different instructions for use. Antiseptic manufacturers’ IFUs convey important safety and efficacy instructions to the user. Failure to adhere to the manufacturer’s IFU may result in patient harm or ineffectiveness of the preoperative patient skin antiseptic.
- Cost – When reviewing the cost of antiseptics, it is important to review contracts, the cost to add the prep to surgical packs, and the additional value offered by the manufacturer or supplier.
Q: Who should be involved in the selection?
LP: AORN recommends that you first convene an interdisciplinary team that includes one or more perioperative RNs, physicians, and infection preventionists to evaluate and select antiseptic products for surgical site preparation.1 This group can also include Infectious Disease, Patient Safety and Quality, Surgeons, Value Analysis Managers, Procurement, and Supply Chain. Decisions about which preoperative skin antiseptic to use in the practice setting are complex. A variety of products may be necessary to meet the needs of various patient populations. Input from an interdisciplinary team with diverse experience and knowledge of skin antiseptics is helpful during the review of the current research, clinical guidelines, and information provided by the manufacturers of surgical antiseptic agents. Lastly, the involvement of an interdisciplinary team also facilitates input from all departments in which the product will be used and from personnel with clinical expertise.1
Q: Who should be involved in the selection?
LP: Skin antiseptics should be supported by clinical evidence. Meta-analysis and systematic reviews of randomized controlled trials are considered the highest levels of clinical evidence. The more rigorous the standards, the less potential for bias and the better the quality of evidence. It is important to note that the efficacy of any formulation is significantly affected by the excipients present. Therefore, trials demonstrating the activity of one formulation cannot be used as evidence for the efficacy of another.2
Study methodology and results need to first be vetted to identify potential bias. Some of these considerations include appropriate sample size (Ns), use of comparators that represent standard of care, meeting of primary and/or secondary endpoints, relevant metrics being used, and the statistical significance of data presented.3,4
Q: What factors should be determined when selecting a skin antiseptic with a tint?
LP: The tint of a skin antiseptic is important to delineate the area that has been prepped. Selecting the right tint is important so that it is visible on a variety of skin tones.1 Selection of tint color is also important to reduce clinical misdiagnoses from skin coloring during post-op care.
Q: What factors should be determined when selecting a skin antiseptic with a tint?
LP: Persistence is defined as the suppression of bacteria growth less than or equal to pre-treatment counts.5
Maintaining low levels of bacteria on the skin while healing is important to minimize bacteria entering the puncture or incision site. While a mature, intact epidermis is an effective barrier to infection, surgery and other invasive procedures break the skin’s barrier, allowing the migration of skin-dwelling and environmental microorganisms into the wound, and increasing the risk of local or systemic infection.6
Once the skin barrier is broken, the inflammatory phase of wound healing (when microorganisms are killed in the wound by immune cells) peaks at 24-48 hours and lasts for several days. Persistence can help minimize the number of microbes that enter the wound during this time period. Re-epithelization works to reestablish the epithelial barrier and promote wound closure over days to weeks.7 Many factors can lead to impaired healing of wounds, including bacterial colonization.8
Q: What is the benefit of a skin antiseptic with a sterile solution?
LP: Over the past 20 years, there have been published reports linking outbreaks of infection to over-the counter (OTC) topical antiseptic agents. Topical antiseptics for preinjection or preoperative skin preparation that were contaminated with microorganisms and have led to product recalls9 from both intrinsic and extrinsic sources.
Contamination can be intrinsic when microorganisms are introduced into a product during the manufacturing process either from pharmaceutical water supplies or nonsterile manufacturing environments. Extrinsic contamination occurs when microorganisms are introduced in association with product use. For example, products can become contaminated when diluted with nonsterile water or transferred for storage into nonsterile containers. Sterile means the solution is free of microorganisms (any microscopic organism such as bacteria). Labeling stating a product is sterile means it was treated with a process during manufacturing to eliminate all potential microorganisms.10 Though not currently required by the FDA, some manufacturers have taken this extra step to sterilize both the applicators and solution where there is less than one in a million chance that a viable microorganism can exist in the antiseptic.11
Q: What are the benefits of dual formulation antiseptics versus single-agent preps?
LP: Using a dual formation antiseptic provides two modes and mechanisms for killing microorganisms. Alcohol has a rapid-acting, broad-spectrum activity against gram-positive and gram-negative bacteria as well as most fungi and virus by denaturing cell proteins. The American College of Surgeons suggests an Alcohol containing preparation should be used unless contraindication exists.12 Dual formation antiseptics with alcohol have been proven to be more effective than single agent preps.13 Chlorhexidine has advantages though over iodophors as a skin antiseptic because it is persistent, effective in the presence of blood and organic matter, and shown to have less sensitivity by patients.14 Antiseptics with chlorhexidine and alcohol have been recommended by the WHO.15 Lastly, AORN recommends using alcohol with an iodophor or chlorhexidine based on the patient assessment and surgical anatomic site.1
Q: What do you see as the biggest challenges to skin prep compliance?
LP: There are multiple factors impacting the correct use of skin antiseptics. A 2016 research article published in International Surgery Journal showed 257 hospitals across the US only achieved adequate prep and dry time 25% of the time. Hospitals see some of this variability from using multiple step processes when applying different antiseptics for a procedure.16 Variability can also include not having an evidence-based standardized process and selected skin prep throughout the facility. Lastly, continuous education for both the nursing staff and surgeons is critical to ensure competency and compliance.
This content is sponsored by BD and contains the opinions of Lena Pearson. The opinions presented herein are for information purposes only and the decision of which antiseptic to use in a particular procedure should be made by the surgeon based on the individual facts and circumstances of the patient.
Lena Pearson is an employee of BD. This Q&A, sponsored by BD, is intended to educate, and train customers regarding the approved use of BD products. As such, unapproved products or indications are not discussed herein. You may contact BD’s Office of Medical Affairs at Medical.information@bd.com for any specific clinical questions you may have.
References
1. AORN Guidelines for Perioperative Practice: Patient Skin Antisepsis
2. G. W. Denton, “Chlorhexidine,” In: S. S. Block, Ed., Disinfection, Sterilization, and Preservation, 5th Edition. Lippincot Williams & Wilkins, Philadelphia, 2001, pp. 321-336.
3. Young JM, et al. Nat Clin Pract Gastroenterol Hepatol. 2009;6(2):82-91.
4. Govani SM, et al. Gastroenterol Hepatol. 2012;8(4):241-248.
5. FDA 12/20/2017 - Final Rule: Finalizes rulemaking for healthcare antiseptics
6. 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
7. desJardins-Park HE, Mascharak S, Chinta MS, Wan DC, Longaker MT. The Spectrum of Scarring in Craniofacial Wound Repair. Front Physiol. 2019 Mar 29; 10:322
8. Wallace HA, Basehore BM, Zito PM. Wound Healing Phases. In: StatPearls. Treasure Island (FL): StatPearls Publishing
9. Weber DJ, Rutala WA, Sickbert-Bennett EE. Outbreaks associated with contaminated antiseptics and disinfectants. Antimicrob Agents Chemother. 2007 Dec;51(12):4217-24.
10. FDA Drug Safety Communication 2013 Nov 13
11. Degala, et al. United States Patent 9,078,934. July 14, 2015
12. 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.
13. Darouiche RO, Et al. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26.
14. Mangram AJ, et al. Infect Control Hosp Epidemiol. 1999;20(4):247-278
15. Global Guidelines for the Prevention of Surgical Site Infection. Geneva: World Health Organization; 2018
16. El-Othmani MM, et al. Assessment of standardization in surgical site preparation: does a compliance culture exist? Int Surg J 2016; 3:1-10.
BD, the BD Logo, ChloraPrep and the Sterile Solutions logo are trademarks of Becton, Dickinson and Company or its affiliates. © 2023 BD. All rights reserved.