Efficacy and safety of a novel skin cleansing formulation versus chlorhexidine gluconate.

BACKGROUND: This study evaluated whether a multi-ingredient surfactant colloidal silver technology was noninferior to a 4% chlorhexidine gluconate (CHG) antiseptic on immediate and persistent antimicrobial activity. METHODS: The inguinal regions of 81 healthy adults were demarcated into 4 quadrants, and 3 were used for testing each product at baseline, 10 minutes, and 6 hours postapplication. The log of the number of colony forming units was obtained using a cylinder sampling technique. The 95% confidence interval of the test product to the control product with a margin of 0.65 was established as the upper limit of noninferiority. RESULTS: A total of 81 individuals were enrolled. The colloidal silver product was found to be noninferior to 4% CHG at both 10 minutes and 6 hours postapplication. CONCLUSIONS: The colloidal silver-based product was noninferior to the 4% CHG product at 10 minutes and 6 hours postapplication.

Antimicrobial activity of a novel adhesive containing chlorhexidine gluconate (CHG) against the resident microflora in human volunteers.

OBJECTIVES: To evaluate the antimicrobial activity of a new, transparent composite film dressing, whose adhesive contains chlorhexidine gluconate (CHG), against the native microflora present on human skin. METHODS: CHG-containing adhesive film dressings and non-antimicrobial control film dressings were applied to the skin on the backs of healthy human volunteers without antiseptic preparation. Dressings were removed 1, 4 or 7 days after application. The bacterial populations underneath were measured by quantitative cultures (cylinder-scrub technique) and compared with one another as a function of time. RESULTS: The mean baseline microflora recovery was 3.24 log10 cfu/cm(2). The mean log reductions from baseline measured from underneath the CHG-containing dressings were 0.87, 0.78 and 1.30 log10 cfu/cm(2) on days 1, 4 and 7, respectively, compared with log reductions of 0.67, -0.87 and -1.29 log10 cfu/cm(2) from underneath the control film dressings. There was no significant difference between the log reductions of the two treatments on day 1, but on days 4 and 7 the log reduction associated with the CHG adhesive was significantly higher than that associated with the control adhesive. CONCLUSIONS: The adhesive containing CHG was associated with a sustained antimicrobial effect that was not present in the control. Incorporating the antimicrobial into the adhesive layer confers upon it bactericidal properties in marked contrast to the non-antimicrobial adhesive, which contributed to bacterial proliferation when the wear time was ≥4 days.

Some basic points concerning meta-analysis.

Multiple studies have been performed on a variety of substances, often producing contradictory results. Meta-analysis has provided a means of evaluating these disparate results, combining them into a summary statistic. Using continuous data for baseline and one sample point, several studies were evaluated to achieve a single result, demonstrating the meta-analysis evaluation process.

Evaluation of persistent antimicrobial effects of an antimicrobial formulation.

CONTEXT: Community-acquired methicillin-resistant Staphylococcus aureus (MRSA) is becoming more prevalent in healthy athletic populations. Various preventive measures have been proposed, but few researchers have evaluated the protective effects of a prophylactic application of a commercially available product. OBJECTIVE: To compare the persistent antimicrobial properties of a commercially available antimicrobial product containing 4% chlorhexidine gluconate (Hibiclens) with those of a mild, nonmedicated soap (Dr. Bronner's Magic Soap). DESIGN: Cross-sectional study. SETTING: Microbiology laboratory, contract research organization. PATIENTS OR OTHER PARTICIPANTS: Twenty healthy human volunteers. INTERVENTION(S): The test and control products were randomly assigned and applied to both forearms of each participant. Each forearm was washed for 2 minutes with the test or control product, rinsed, and dried. At, 1, 2, and 4 hours after application, each forearm was exposed to MRSA for approximately 30 minutes. MAIN OUTCOME MEASURE(S): Differences in numbers of MRSA recovered from each forearm, test and control, at each post-application time point were compared. RESULTS: Fewer MRSA (P < .0001) were recovered from the forearms treated with the test product (4% chlorhexidine gluconate) than from the forearms treated with the control product (nonmedicated soap). CONCLUSIONS: The 4% chlorhexidine gluconate product demonstrated persistent bactericidal activity versus MRSA for up to 4 hours after application.

Comparative of a new and innovative 2% chlorhexidine gluconate-impregnated cloth with 4% chlorhexidine gluconate as topical antiseptic for preparation of the skin prior to surgery.

BACKGROUND: Decreasing the microbial skin burden reduces the risk of surgical site infection (SSI). The present study compares the activity of an innovative 2% chlorhexidine gluconate (CHG)-impregnated preoperative skin preparation cloth (PC) with a standard application procedure with a 4% CHG surgical skin preparation (SP). METHODS: A paired, randomized, parallel phase III study was conducted adhering to the Food and Drug Administration (FDA) design criteria for evaluating preoperative skin preparations. Subjects' left and right sides of the inguinal and abdominal skin sites (n = 30) were randomized to either PC or SP treatment. Following baseline cultures, PC sites were prepped for 3 minutes, and SP sites were prepped for 4 minutes. Skin site cultures were obtained at 10 minutes, 30 minutes, and 6 hours postpreparation. Bacterial recovery was expressed as log(10) colony-forming units (cfu)/cm(2) for baseline and postapplication microbial recovery. RESULTS: Mean microbial baseline for the abdominal and inguinal skin sites were as follows: PC = 3.36 cfu/cm(2) and 6.15 cfu/cm(2); SP = 3.51 cfu/cm(2) and 6.16 cfu/cm(2), respectively. Log(10) reduction for PC abdominal and inguinal prepped sites at 10 minutes, 30 minutes, and 6 hours postpreparation were 2.50, 2.33, and 2.54; 3.45, 3.50, and 3.64, respectively. Log(10) reductions for SP abdominal and inguinal prepped sites at 10 minutes, 30 minutes, and 6 hours were 2.18, 2.19, and 2.77; 2.78, 2.63, and 3.15, respectively. CONCLUSION: Microbial reductions from abdominal-inguinal PC prepped sites were significantly reduced (P < .05) compared with baseline, exceeding the FDA log-reduction criteria for a preoperative topical skin preparation. Compared with baseline, microbial reductions at the SP-prepped abdominal-inguinal sites were significant (P < .05). SP abdominal-prepped sites met the FDA log-reduction criteria; inguinal sites, however, failed to meet expected FDA log-reduction criteria at 10 minutes postpreparation. The PC-treated inguinal sites at 10 minutes, 30 minutes, and 6 hours post-skin preparation demonstrated significantly greater microbial reductions than did the SP-treated inguinal sites (P < .01).

Evaluation of two methods of determining the efficacies of two alcohol-based hand rubs for surgical hand antisepsis.

The antimicrobial efficacies of preparations for surgical hand antisepsis can be determined according to a European standard (prEN 12791 [EN]) and a U.S. standard (tentative final monograph for health care antiseptic drug products [TFM]). The U.S. method differs in the product application mode (hands and lower forearms, versus hands only in EN), the number of applications (11 over 5 days, versus a single application in EN), the sampling times (0, 3, and 6 h after application, versus 0 and 3 h in EN), the sampling methods (glove juice versus fingertip sampling in EN), and the outcome requirements (absolute bacterial reduction factor [RF], versus noninferiority to reference treatment in EN). We have studied the efficacies of two hand rubs according to both methods. One hand rub was based on 80% ethanol and applied for 2 min, and the other one was based on 45% propan-2-ol, 30% propan-1-ol, and 0.2% mecetronium etilsulfate and applied for 1.5 min. The ethanol-based hand rub was equally effective as the 3-min reference disinfection of prEN 12791 in both the immediate (RFs, 2.97 +/- 0.89 versus 2.92 +/- 1.03, respectively) and sustained (RFs, 2.20 +/- 1.07 versus 2.47 +/- 1.25, respectively) effects. According to TFM, the immediate effects were 2.99 log10 (day 1), 3.00 log10 (day 2), and 3.43 log10 (day 5), and bacterial counts were still below baseline after 6 h. The propanol-based hand rub was even more effective than the reference disinfection of prEN 12791 in both the immediate (RFs, 2.35 +/- 0.99 versus 1.86 +/- 0.87, respectively) and sustained (RFs, 2.17 +/- 1.00 versus 1.50 +/- 1.26, respectively) effects. According to TFM, the immediate effects were 2.82 log10 (day 1), 3.29 log10 (day 2), and 3.25 log10 (day 5), and bacterial counts were still below baseline after 6 h. Some formulations have been reported to meet the efficacy requirements of one of the methods but not those of the other. That is why we conclude that, despite our results, meeting the efficacy requirements of one test method does not allow the claim that the requirements of the other test method are also met.

Efficacy of preoperative antimicrobial skin preparation solutions on biofilm bacteria.

RESEARCH ON THE MEDICAL EFFICACY of topical antimicrobials and antibiotics against infections has focused largely on the effect on free-floating, planktonic bacteria. IN THE PRESENCE OF nonbiological surfaces (eg, catheters, prosthetic devices, biomaterials), however, bacteria form highly complex biofilm systems that resist traditional medical treatment. BACTERIAL PATHOGENS commonly found in chronic infections in both the planktonic and biofilm state were challenged with a variety of commonly used topical antimicrobial formulations. BIOFILM BACTERIA were shown to be more resistant to killing than planktonic bacteria. Antimicrobial skin preparation times were adequate to significantly reduce bacterial populations protected in biofilms.

Hand scrub products--performance requirements versus clinical relevance.

The US Food and Drug Administration regulates antimicrobial label claims for surgical hand scrub products. Surgical scrub products must meet preset performance criteria for immediate, persistent, and residual antimicrobial properties. Although the test currently used to validate surgical hand scrub products is rigorous in research methodology, it lacks practical clinical relevance.

A simulated-use evaluation of a strategy for preventing biofilm formation in dental unit waterlines.

BACKGROUND: Prevention of biofilm formation is important in the maintenance of dental unit waterline systems. Without effective control measures, the waterlines will become contaminated with routine use. METHODS: The authors used a simulated-use dental unit waterline system to evaluate the ability of a test product, A-dec ICX (A-dec, Newburg, Ore.), to prevent biofilm formation. They evaluated buffered distilled water and hard water models versus mixed-challenge suspensions of Staphylococcus aureus, Klebsiella pneumoniae and Pseudomonas aeruginosa. RESULTS: The authors documented development of significant biofilm in untreated test units, while treated test units showed no indication of biofilm formation throughout the 16-week study. Student t tests and 95 percent confidence intervals performed on the plate count data confirmed that untreated test units had significantly greater bacterial populations than did treated test units (P < .05). Qualitative images by scanning electron microscopy verified these findings. CONCLUSION: In this simulated clinical-use study, the test product effectively reduced bacterial counts in incoming water and produced water quality exceeding stated recommendations of the American Dental Association. CLINICAL IMPLICATIONS: The test product provides an approach to dental unit waterline maintenance that is simple to use and that, by continuously preventing biofilm formation, reduces concerns about bacterial contamination in dental unit water.

Taking care of patients and caring for patients are not the same.

THERE IS A SIGNIFICANT difference between taking care of patients and caring for patients. TAKING CARE OF PATIENTS emphasizes objective, professional care, such as the medical and psychological aspects of nursing. CARING FOR PATIENTS, on the other hand, is a humanistic way of interacting with patients that demonstrates sincere care and concern for patients simply because they are human beings.