Prospective Evaluation of 6 Preoperative Cutaneous Antiseptic Regimens for Prevention of Surgical Site Infection

Background: Minimizing the bioburden of cutaneous microflora on the surgical site prior to surgery is fundamental to prevention of surgical site infection (SSI). Few studies have prospectively evaluated the adjunctive value of a continuum of advance preoperative antiseptic prepping and the efficacy of differing antiseptic agents for preoperative disinfection of the surgical site in the operating room. Purpose: To ascertain the relative efficacy of an advance preoperative antiseptic skin preparation with a rinse-free 2% chlorhexidine gluconate (CHG)-impregnated washcloth (Sage) combined with 3 different antiseptic regimens for final preoperative disinfection of the surgical site in the operating room. Methods: 126 healthy adult subjects underwent quantitative sampling of the aerobic cutaneous microflora on the anterior chest and inguinal areas prior to an advance antiseptic skin preparation with a 2% CHG washcloth or triclosan soap (Dial) (control). Subjects were randomized to 6 regimens in a crossover design, with ~ 40 subjects per group: 2 advance preoperative applications using the 2% CHG cloth, without rinsing, or showering with triclosan soap, followed ~12 hours later by a final OR skin preparation of the subclavian and inguinal areas with the 2% CHG washcloth, 0.7% alcoholic tincture of povidone-iodine (PI) (DuraPrep, 3M) or 10% aqueous PI (Scrubcare Preop Skin Prep, Cardinal Health). Subjects underwent 5 quantitative sampling of each site using the standard scrub cup method: prior to the first advance skin preparation (baseline), following the 1st and 2nd application, and 10 minutes and 6 hours after the final skin prep in the operating room; appropriate neutralizers were employed. Results: All of the regimens were well tolerated. Use of the 2 advance preoperative rinse-free skin preps with 2% CHG significantly lowered the number of microorganisms on both potential surgical sites as compared with control triclosan soap showering (>1 log , P<0.001). Although not consistently significant, the reductions following the final surgical site preop prep with all 3 surgical site skin prep products were ~0.5 log 10 greater for subjects who had had an advance rinse-free 2% CHG prep than those who showered with triclosan. Conclusions: This study shows that advance preoperative skin preparation with 2% CHG done twice, ~12 and ~3 hours prior to anticipated surgery, without rinsing, significantly reduces the number of microorganisms on the surgical site at the time the incision is made, regardless of the agent used in the final surgical site prep in the operating room. There is an urgent need for a large multicenter trial to determine with clinical outcome data whether advance preparation of the site with multiple rinse-free applications of 2% CHG prior to elective surgery, with prolonged exposure to the antiseptic, significantly reduces the rate of SSI and, also, whether 2% CHG might be superior to iodophores for the final prep of the surgical site in the OR, which has been the standard of care in North America for nearly 50 years. INTRODUCTION REFERENCES DISCUSSION More than 25 million inpatient surgical procedures were reported in 2002.1 In that year almost 135 thousand patients were discharged with a diagnosis of postoperative surgical site infection (SSI); the average length of hospitalization for these patients was 7.5 days and mean hospital charges were $24,346, resulting in aggregate charges of almost 3.3 billion dollars.2 Kirkland et al reported that patients who develop SSI have longer and costlier hospitalizations than patients who do not develop such infections, are 60% more likely to spend time in an ICU and twice as likely to die, and more than five times more likely to be readmitted to the hospital.3 Patients with orthopedic SSIs suffer major physical limitations and reductions in health-related quality of life.4 The incidence of SSI is much higher after cleancontaminated, contaminated, or dirty operations than clean surgeries, because the surgical wound in non-clean surgeries are exposed to a much larger number and variety of organisms originating from mucous membranes, colonized hollow viscera or infected tissues.5 In contrast, SSIs following clean surgery are caused in nearly all cases by endogenous organisms colonizing the patient’s skin and introduced into the surgical wound during operation.6-8 Most of the ritual of intraoperative surgical asepsis – including preoperative hair removal, the antiseptic scrub of the surgical team, sterile surgical gowns and drapes, the antiseptic preparation of the surgical site in the operating room, and the use of perioperative antimicrobial prophylaxis5 – is designed to minimize cutaneous colonization of the surgical site and intra-operative contamination of the wound in order to prevent subsequent infection. Whole body bathing or showering with an antiseptic agent, such as 2-4% chlorhexidine gluconate, has been reported to reduce bacterial colonization of the skin.9,10 Studies have shown that the antibacterial effect of chlorhexidine is cumulative11,12 and lasts longer than that produced by other antiseptic agents.13-15 In the first comparative clinical (non-randomized) trial, Brandberg et al showed that multiple preoperative chlorhexidine showers significantly reduced the incidence of SSI.16 In a large prospective randomized trial conducted by Hayek et al, preoperative chlorhexidine baths markedly reduced the incidence of SSI, especially those caused by Staphylococcus aureus,17 and chlorhexidine showers were also effective in another Swedish study.18 However other studies showed either minimal (and statistically insignificant) benefit19,20 or no measurable impact of preoperative chlorhexidine showers or baths on the incidence of SSI.21-25 We report a prospective study undertaken in volunteers to evaluate the adjunctive value for disinfection of the surgical site of employing a continuum of preoperative antiseptic prepping, including with a novel chlorhexidine-impregnated washcloth without rinsing, combined with use of differing antiseptics for preoperative disinfection of the surgical site in the operating room. Advanced Preop Skin Preparation OR Preop Site Preparation