Dr. Boykin offered an expert opinion in Healio’s Orthopedics Today

At Issue: Chlorhexidine gluconate bathing; Is chlorhexidine gluconate bathing prior to orthopedic surgery effective at infection prevention? If so, why?

It makes sense to apply a product that may reduce bacterial burden

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.

For more information the original article can be found here:

At Issue: Chlorhexidine gluconate bathing; Is chlorhexidine gluconate bathing prior to orthopedic surgery effective at infection prevention? If so, why?

Disclosure: Dr. Boykin 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.