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Industry: Email Alert RSS FeedSurgical prep products; obesity and postoperative complications; flammability of drapes; atypical mycobacterial infection
AORN Journal, June, 2007 by George Allen
Comparison of chlorhexidine gluconate preparation products
American Journal of Infection Control March 2007
Surgical site infections (SSIs) are associated with a significant level of morbidity and mortality. Consequently, reducing the risk of SSI is a high priority that deserves prompt attention and aggressive efforts. The cornerstones for reducing the risk of SSI include employing fastidious surgical technique, using appropriate and timely antibiotic prophylaxis with intraoperative redosing based on the length of surgery, and using effective and persistent skin antisepsis.
The US Food and Drug Administration notes that for a product to be labeled as a preoperative skin preparation, it must rapidly reduce (ie, within 10 minutes of application) the number of both transient and resident microorganisms within the surgical field before the surgical incision is made, and microbial regrowth should be suppressed for six hours after the skin prepping agent is applied. Chlorhexidine gluconate (CHG) is generally recognized as an effective component in preoperative skin preparation agents in terms of both antimicrobial activity and prolonged activity. The purpose of this matched-pair, bilaterally randomized study was to compare the activity of a 2% CHG-impregnated preoperative skin preparation cloth with a standard application procedure using 4% CHG surgical skin preparation. (1)
Two anatomical sites were selected for testing: the abdomen near the umbilicus and at the inguinal crease of the innermost aspect of the upper thigh. Thirty healthy volunteers were recruited, and the two treatments were randomly assigned to the abdominal and inguinal sites of each participant so that one product was applied on one side of the abdomen and inguinal area and the other product was applied contralaterally. Screening baseline cultures of the skin surface were collected, and a minimum microbial population of 5.0 [log.sub.10] colony forming unit (cfu)/[cm.sup.2] on the skin surface at the moist inguinal site and 2.5 [log.sub.10] cfu/[cm.sup.2] on the skin surface at the dry abdominal site was required for participants to continue in the study.
Within seven days after the screening baseline cultures were collected, a baseline sample of each test site was performed again. The two test products again were randomly assigned to each participant so that one product was applied to one side of the abdomen and inguinal area and the second product was applied to the other side. Samples were taken three times within six hours after product application, with specific sampling sites at the abdominal and inguinal regions randomly assigned for each of the three post-treatment sample times.
The 2% CHG-impregnated preparation cloth was applied to the designated area using a vigorous back-and-forth motion for 1.5 minutes; it was then turned over, and the 1.5 minute-procedure was repeated. The 4% CHG preparation was applied to the site with sterile gauze for two minutes. After excess solution was blotted up with sterile gauze, a second application of the 4% CHG preparation was applied to the sampling site for an additional two minutes.
The designated sampling sites were cultured 10 minutes, 30 minutes, and six hours after the products were applied. After the 30-minute sample was collected, a sterile gauze and fenestration dressing was secured to the inguinal and abdominal study sites to protect these regions from extraneous contamination. Common statistical procedures were used to analyze the results of the culturing.
Findings. There were no adverse events in either the 2% CHG-impregnated preparation cloth or 4% CHG preparation arms of the study. The mean microbial counts at baseline for the abdominal and inguinal sites were 3.36 cfu/[cm.sup.2] and 6.15 cfu/[cm.sup.2], respectively, for the preparation cloth versus 3.51 cfu/[cm.sup.2] and 6.16 cfu/[cm.sup.2], respectively, for the 4% CHG preparation. For the preparation cloth, [log.sub.10] reductions from baseline microbial counts at 10 minutes, 30 minutes, and six hours after preparation were 2.50, 2.33, and 2.54, respectively, for the abdominal sites and 3.45, 3.50, and 3.64, respectively, for the inguinal sites. [Log.sub.10] reductions from baseline microbial counts for the 4% CHG preparation at 10 minutes, 30 minutes, and six hours after preparation were 2.18, 2.19, and 2.77, respectively, for the abdominal sites and 2.78, 2.63, and 3.15, respectively, for the inguinal sites. Use of the 2% preoperative skin preparation cloth in the inguinal sites resulted in a significantly greater [log.sub.10] microbial reduction at all the time intervals (10 minutes, P < .000001; 30 minutes, P < .0001; six hours, P < .01) compared with use of the 4% CHG traditional skin preparation agent.
Clinical implications. The results of this study revealed that the preoperative skin preparation cloth with 2% CHG was significantly more effective in reducing microbial counts in the inguinal sites than the traditional 4% CHG skin preparation agent. Perioperative nurses and managers should consider that the innovative design of this preoperative skin preparation cloth could make this product appropriate for use in both inpatient and outpatient surgical areas during preparation for surgery--for example, as an alternative to preoperative showering, particularly in instances in which preoperative showering may be difficult or not recommended.