Comparison of a New and Innovative 2% Chlorhexidine Gluconate (CHG) Impregnated

Preparation Cloth with the Standard 4% CHG Surgical Skin Preparation

Edmiston C Jr, PhD, MS, CIC, Seabrook GR, Johnson CP, et al.

OVERVIEW METHODS RESULTS LESSONS LEARNED

It is estimated that 750,000 surgical site infections The FDA requires antiseptic skin products to An open-label, matched-pair, parallel, phase-III clinical • There were no adverse events in Table 1: Reductions in bacterial counts at inguinal sites after skin preparation
• The alcohol-free 2% CHG PC is a new,
(SSIs) occur in the USA each year. This results in demonstrate rapid reduction in transient and resident study was done on 30 volunteers. The subjects were either treatment group. 500 mg equivalent CHG product that allows
increased patient morbidity and mortality and costs microbes in the surgical field prior to incision. The screened with baseline skin sampling bilaterally on the preoperative skin prep in one step without
more than $1.6 billion in excess hospital charges.1 antiseptic must also maintain its effectiveness (a 3.0 abdomen near the umbilicus and at the inguinal crease of • Baseline microbial counts from the
blotting or removal of excess CHG.
Effective and persistent skin antisepsis is one of theLog10 reduction from baseline) for at least 6 hours the inner-most aspect of the upper thigh. Those subjects inguinal sites were equivalent.
key measures to reduce the risk of SSI. post application.4 With these requirements in mind, with bacterial counts of a minimum of 5.0 log10 CFU/cm2 • The alcohol-free 2% CHG PC demonstrated
• At 10 minutes, 30 minutes, and
this study sought to compare the efficacy of this new at the inguinal site and 2.4 log10 CFU/cm2 at the significantly greater log10 microbial reduction in
6 hours post-application, the 2%
The peri-operative nurse can help meet the challenges alcohol-free 2% CHG prepping cloth (PC) to the abdominal site were entered into the study. the inguinal site for the entire testing period compared
CHG PC demonstrated statistically
of reducing SSI through his or her role in complete standard 4% CHG surgical skin prep (SP). to the 4% CHG SP.
significant reductions in microbial
skin antisepsis. Choosing an One product was applied to one side of each subject and
counts (P<.05) in both the inguinal and • The amount of preparation time required for
effective skin preparation This study found that the 2% the second product to the other side. Computer
abdominal sites. microbial reduction was less with the 2% CHG
product can mean the CHG PC treatment led to a randomization was used to determine sampling sites for
difference between an
“The non-abrasive texture significantly greater log10 each of 3 post-treatment sampling times of 10 minutes,
Table 2: Reductions in bacterial counts at abdominal sites after skin preparation
product compared to the 4% CHG solution (3 minutes
• The reduction in microbial counts
uneventful surgical recovery microbial count reduction in 30 minutes, and 6 hours. vs 4 minutes).
and a multi-drug resistant of the 2% CHG preoperative
at the abdominal sites with both
inguinal areas compared to preparations exceeded the FDA • The antimicrobial effects from the 2% CHG
SSI for your patient. CHG is the 4% CHG SP at all testing The 2% CHG PC was applied with vigorous wiping motion
a commonly used skin skin prepping cloth most likely times (10 minutes, 30 for 1.5 minutes, then turned to the unused side and used
requirements. (Table 2) product persisted on the skin for a full 6 hours
after application.
antiseptic that is effective minutes, 6 hours; P<0.05). for an additional 1.5 minutes (total treatment time: 3 • The 2% CHG PC exceeded the
and persists on the skin to promotes a gentle exfoliation The non-abrasive texture of minutes). The 4% CHG SP solution was applied liberally FDA requirements for reduction in • The non-abrasive, polyester skin preparation
provide prolonged the 2% CHG preoperative skin with gauze for 2 minutes and blotted with sterile gauze; microbial counts in the inguinal area at cloth most likely promotes a gentle exfoliation
antisepsis.2 An alcohol-free of skin cells within the prepping cloth most likely this was repeated as a second application for an all sample times. (Table 1) of skin cells that allows for a more thorough
2% CHG preparation is now promotes a gentle exfoliation additional 2 minutes followed by blotting with sterile antiseptic effect immediately after application.
available in a no-rinse, prepped area, allowing for a of skin cells within the gauze (total treatment time: 4 minutes). • The 4% CHG SP failed to meet
Mean microbial counts (log10) following product application
preoperative skin prepped area, allowing for a the FDA requirements for reduction • The ease of use may make it easier for
preparation, offering a one- more thorough antiseptic more thorough antiseptic Sites were sampled at 10 minutes, 30 minutes, and 6 in microbial counts in the inguinal area patients to comply with early preoperative skin
step method for presurgical effect within the immediate hours after treatment. The skin was sampled using a at 10 minutes. (Table 1) preparation (night before, morning of) to reduce
preparation. effect within the immediate post-application period. CHG neutralizer combined with a sterile stripping fluid. microbial contamination.
After the 30-minute sample was done, the sampling
CHG, one of the most post-application period. ” In addition to superior area of the skin was protected with sterile gauze to
Soft fibers gently exfoliate while
evenly distributing 2% CHG
commonly used skin reduction in inguinal microbial prevent contamination before the 6 hour sampling time.
antiseptics, offers the counts, the 2% CHG PC was The samples were immediately processed for culturing REFERENCES
benefit of prolonged activity on the surface of the easier to use because it required no blotting or and incubation.
skin.3 This is of particular benefit during long surgical removal of excess CHG. This would be particularly 1. Zhan C, Miller MR. Excess Length of Stay, Charges, and Mortality Attributable to Medical Injuries
During Hospitalization. JAMA. 2003; 290:1868-1874.
procedures or in body areas with high humidity and useful (with or without assistance) for patients, such Confidence intervals were determined for baseline and
high bacterial counts, such as the inguinal region. A as orthopedic patients who are immobilized, who find post-application microbial recovery between study 2. Jackson M. Topical Antiseptics in Healthcare. Clin Lab Sci. 2005;18(3):160-169.

product that incorporates 2% CHG into a polyester,
no-rinse, alcohol-free skin prepping cloth is now
available.
it difficult to comply with early preoperative skin
preparation (night before, morning of) to reduce
preoperative microbial contamination prior to hospital
admission and surgery.
materials from calculated descriptive statistics. The 3. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. The Hospital Infection Control Practice
Advisory Committee, Guidelines for the prevention of surgical site infections. Am J Infect Control
confidence intervals were calculated using the MINITAB® 1999; 27:97-132.
(Version 14) statistical computer package. Matched-pair 4. Food and Drug Administration, 21CRF Parts 333 and 369. Tentative final monograph for healthcare
t-tests were used to compare the 2% CHG PC and 4% CHG antiseptic drug products: proposed rules. Federal Register Part III, 1994; 59 (116): 31401-31452.

SP treatments directly.
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