Issue: May 2020
Source/Disclosures
Disclosures: Boykin reports he is a consultant for and does educational speaking and product development for Smith & Nephew, and is a member of the scientific advisory board for Avadim Health. Ricchetti reports no relevant financial disclosures.
May 22, 2020
6 min read
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At Issue: Chlorhexidine gluconate bathing

Is chlorhexidine gluconate bathing prior to orthopedic surgery effective at infection prevention? If so, why?

Issue: May 2020
Source/Disclosures
Disclosures: Boykin reports he is a consultant for and does educational speaking and product development for Smith & Nephew, and is a member of the scientific advisory board for Avadim Health. Ricchetti reports no relevant financial disclosures.
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It makes sense to apply a product that may reduce bacterial burden

by Robert E. Boykin, MD

Robert E. Boykin, MD
Robert E. Boykin

Surgical site infection is a devastating complication after orthopedic surgery. There has been much debate regarding the efficacy of chlorhexidine gluconate for presurgical bathing to reduce surgical site infection risk. A presurgical shower with 2% or 4% aqueous chlorhexidine gluconate, or CHG, was designated as “strongly recommended” in the 1999 CDC Guideline for the Prevention of [surgical site infection] SSI based on the ability of CHG to reduce the skin’s microbial colony counts without definitive evidence of reducing SSI. A number of studies have been published in the orthopedic literature since that time with contradictory findings regarding infection reduction. A randomized controlled trial that Bhaveen H. Kapadia, MD, and colleagues conducted in patients undergoing arthroplasty demonstrated a lower rate of SSI with preoperative use of CHG over soap and water, while a systematic review by Joan Webster, RN, RM, BA, and colleagues in the Cochrane database of 10,157 patients showed no clear benefit of CHG over other wash products. A recent international consensus paper by Gerald J. Atkins, PhD, and colleagues on orthopedic infections expressed a moderate evidence recommendation of CHG for presurgical bathing based on a potential upside with limited downside. However, the paper concluded the current literature could not affirm emphatically that skin cleansing at home has a role in the reduction of SSI.

Rationale for using CHG

The biological rationale for using CHG to reduce the bacterial burden on the skin is evident and well documented in the literature, with bacteriostatic and bactericidal effects depending on the concentration applied. The mechanism of action is cell membrane disruption with rapid effect (less than 30 seconds). Contact dermatitis is one of the more commonly documented adverse events with cytotoxicity to human dermal fibroblast having been described in studies by E. Hidalgo and colleagues, and by James X. Liu, MD, and colleagues. In addition, other risks have been more recently considered. The FDA issued a Drug Safety Communication in 2017 that warned of cases of anaphylactic reactions to CHG. Although these incidents were exceedingly rare, it should be noted the updated CDC Guideline for the Prevention of SSI from 2017 removed the aforementioned recommendation for CHG. The current guideline, Section 8A.1, now reads, “Advise patients to shower or bathe (full body) with soap (antimicrobial or nonantimicrobial) or an antiseptic agent on at least the night before the operative day. (Category IB–strong recommendation; accepted practice.).” Section 8A:2 follows, “Randomized controlled trial evidence suggested uncertain trade-offs between the benefits and harms regarding the optimal timing of the preoperative shower or bath, the total number of soap or antiseptic agent applications, or the use of chlorhexidine gluconate washcloths for the prevention of SSI. (No recommendation/unresolved issue.)”

Reduce bacterial burden

Anecdotally, some of my partners and I had noticed a number of skin reactions in surgical patients after presurgical CHG bathing, some of which caused procedures to be delayed or canceled. In looking at alternative options, I began to consider that perhaps we are approaching presurgical bathing the wrong way. For skin preparation in the OR, we want to use the most potent antibacterial product available, even if this is somewhat caustic to the skin, to immediately reduce the bacterial colonization before incision. For the presurgical bathing period, typically the 24 to 72 hours prior to surgery, it would seem to make more sense to apply a product that could reduce the bacterial burden but also optimize, rather than harm, the skin in preparation for surgery. To this end, we began to study a surfactant-based product with allantoin and colloidal silver, Theraworx Protect (Avadim Health). The acidic pH of the topical product is thought to reduce the burden of pathologic bacteria but also improve the biologic function of the stratum corneum layer of the skin. In a basic science study by Daryl S. Paulson, PhD, MBA, and colleagues, the product was noninferior to CHG 4% in reducing bacteria on human skin. Given these data and to remain in compliance with the CDC recommendations, we began having patients use this product for presurgical bathing, keeping all other aspects of skin preparation the same. We have followed more than 1,000 patients in our database. Our unpublished data show fewer skin reactions to the product and a non-significant trend towards a lower overall rate of SSI.

Clearly, prospective studies are needed to assess the efficacy of this and other potential alternatives to CHG for presurgical bathing. Even small reductions in SSI and adverse events can create significant cost savings to the health care system and allow us to deliver better care to our patients. Perhaps the next step is a paradigm shift in how we think about “preparing” the skin for surgery — to view this through a lens of optimizing the skin function and microbiome rather than a scorched earth approach.

Disclosure: Boykin reports he is a consultant for and does educational speaking and product development for Smith & Nephew, and is a member of the scientific advisory board for Avadim Health.

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Benefits of preoperative CHG washes are variable

by Eric T. Ricchetti, MD

Eric T. Ricchetti, MD
Eric T. Ricchetti

SSIs and periprosthetic joint infections are among the most serious complications associated with orthopedic and arthroplasty surgery, leading to poor outcomes, increased cost and technically difficult revision surgery. Although appropriate diagnosis and treatment of these devastating infections are essential to optimize outcomes, equally important are prevention strategies to decrease or eliminate the risk of SSIs or prosthetic joint infections at the time of the primary orthopedic procedure. Preventative strategies can be applied perioperatively to lower infection risk, including preoperative modification of host-related and local risk factors, surgical site preparation prior to surgery, antibiotic choice perioperatively, intraoperative best practices with regard to OR environment, surgical field set-up and surgical technique, as well as surgical closure and postoperative wound care.

In addition to skin preparation at the time of surgery, skin cleansing at home prior to orthopedic surgery has become a routine component of preoperative infection prophylaxis with extensive research to determine the clinical benefit of this practice and the optimal cleansing agent. The Second International Consensus Meeting (ICM) on Orthopedic Infections was held in July 2018, with experts from orthopedic surgery, infectious disease, microbiology and epidemiology assembled in consensus workgroups to update or establish new guidelines for the prevention, diagnosis and treatment of musculoskeletal infections based on the best evidence available and using a rigorous Delphi method process. The role of preoperative skin cleansing at home prior to orthopedic surgery in reducing infection risk was an important question investigated at this meeting, with a consensus recommendation made that this practice has a role in the reduction of subsequent SSIs and prosthetic joint infections (PJIs), and that CHG, specifically, has been shown to have excellent results in preventing SSIs or PJIs. CHG bathing at home before surgery involves either a 4% solution or a 2% cloth for a varying number of days and has shown increased effectiveness compared to other cleansing agents, such as povidone-iodine.

Results for SSI, PJI reduction

Although the ICM workgroup has recommended its use, there are conflicting results in the literature on the benefit of preoperative CHG bathing for reduction of SSIs and PJIs, leading to different views on its use by other infection prevention organizations. Bhaveen H. Kapadia, MD, and colleagues, evaluated 3,717 patients who underwent primary or revision total knee arthroplasty and found that the use of preoperative CHG was associated with a reduced relative risk of PJI after TKA at 1-year postoperatively (0.3%) compared with patients who did not receive it (1.9%) (RR = 6.3; 95% CI, 1.9-20.1; P = .002), a finding the investigators replicated in a prospective randomized controlled trial of 539 patients undergoing either total hip arthroplasty or TKA. However, recent large systematic reviews and meta-analyses of more than 10,000 patients each by M. Piotr Chlebicki, MBBS, ABIM, and colleagues, and Webster and colleagues have shown that preoperative washing with CHG was not associated with lower infection rates postoperatively. In addition, a review of the literature demonstrates the heterogeneity of skin cleansing regimens across studies, as well as the varying compliance rates in using these agents as directed, making it difficult to isolate whether preoperative CHG washing is a significant factor in infection prevention in patients undergoing orthopedic surgery. For example, another study by Kapadia and colleagues from 2015 showed 78% of patients undergoing THA or TKA were noncompliant with a preoperative CHG disinfection protocol despite focused instruction on use at the time of surgical scheduling or during preoperative evaluation.

CHG effectiveness may vary by case

The benefit of CHG washes may also vary based on the surgery being performed and the particular bacterial profile of infections following that procedure. PJI following shoulder arthroplasty, for example, commonly has an indolent presentation due to the low virulence of the causative organisms, such as Cutibacterium acnes, and while studies in the shoulder have shown preoperative CHG washes lower bacterial growth on the skin prior to surgery, a decrease in infection rate postoperatively has not been demonstrated. As a result, the ICM workgroup was unable to make a definitive recommendation on CHG use prior to shoulder arthroplasty.

Additional, well-controlled, prospective studies are needed to further assess the efficacy of preoperative CHG washes and how this may vary across different orthopedic procedures. Large, well-designed trials will be required to demonstrate if this practice is of clinical benefit and cost-effective and to determine the optimal application protocol because of the low prevalence of SSIs and PJIs. Although adverse events of CHG bathing are reportedly infrequent and mild, studies can also be designed to further assess side effect profile and patient compliance with use.

Disclosure: Ricchetti reports no relevant financial disclosures.