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At least 181 records · Page 10Linked to original sources
PubMed2006

Reproducibility and workability of the European test standard EN 12791 regarding the effectiveness of surgical hand antiseptics: a randomized, multicenter trial.

OBJECTIVES: To evaluate the reproducibility and workability of the in vivo test model of the European test standard EN 12791 regarding the effectiveness of surgical hand antiseptics and, as a secondary objective, to evaluate the power of the model to discriminate between the effectiveness of various formulations of surgical hand antiseptics. DESIGN: Prospective, randomized, multicenter study with a Latin square design. SETTING: Five laboratories at 2 universities, 2 disinfectant manufacturers, and 1 private testing institution. PARTICIPANTS: Twenty healthy adults in each laboratory. INTERVENTION: Surgical hand antisepsis was performed by scrubbing with chlorhexidine gluconate 4% detergent (CHG) or by rubbing the hands with propan-2-OL (70% by volume; Iso 70) or ethanol 85% (E 85); rubbing the hands and forearms for 3 minutes with propan-1-OL (N 60) was used as the reference disinfection procedure. We deliberately chose to use these antiseptics at the given concentrations because they were intended to cover the range of typical antiseptics submitted for approval according to EN 12791. METHODS: In once-weekly tests, the immediate effects of the 4 antiseptics were established according to the method laid down in EN 12791 by assessing the release of skin flora from the fingertips as viable bacteria counts per milliliter of sampling fluids before treatment and viable bacteria counts immediately after treatment, separately for both hands, such that after 4 weeks each volunteer had used every formulation once. RESULTS: The mean log reduction factor (RF) for the release of bacterial skin flora (the log RF was calculated as the log count before treatment minus the log count after treatment) and corresponding standard deviations for the 4 hand antisepsis formulations were as follows: for CHG, 1.1+/-0.3 colony-forming units (cfu) per milliliter of sampled fluid; for Iso 70, 1.7+/-0.3 cfu/mL; for E 85, 2.1+/-0.3 cfu/mL; and for N 60, 2.4+/-0.4 cfu/mL. The differences between these values proved significant (P<.001) by analysis of variance and in Tukey's "honestly significantly different" (HSD) post hoc test. Although, with regard to their immediate antibacterial activity, the same ranking of these antiseptics was found at all laboratories, the levels of efficacy were significantly different across laboratories (P<.001); no statistical difference was found between left and right hands (P>.01). Relating the log RF values of the other 3 formulations to those of the reference formulation (N 60) abolished differences between laboratories (P=.16); in addition, the interclass correlation coefficient decreased from 9.1% to 4.5%. With 20 volunteers, a minimum difference of 0.47 log between the mean log RFs of the reference formulation and an inferior test formulation will be detected as significant at an alpha of .05 (1-sided) and a 1- beta value of .8. CONCLUSION: The test method described in EN 12791 yielded the same conclusion on the effectiveness of the tested formulations in every laboratory and proved, therefore, reproducible and workable.

2-Propanol↗
PubMedDate not supplied

Efficacy and local tolerability of povidone iodine and octenidine hydrochloride solution for the antiseptic preparation of the orificium urethrae.

In a randomized clinical study, 61 hospitalized men were examined to test the local tolerability and antimicrobial efficacy of antiseptic treatment of the genitals with povidone iodine versus octenidine hydrochloride solution. Antibacterial efficacy was established by comparing the total aerobic bacterial colony count from standardized swabs from the orificium urethrae externum before, immediately after, and 30 and 60 min after antisepsis. Tolerability was assessed by dermatoscopy, applying a scale to rate the criteria of reddening, erosions and microbleeding. pH-value was taken and the nitracin yellow test carried out at several intervals. Patients assessed sensations (itching, burning, warmth, cold tension) in visual analogue scales. The test for equivalence in efficacy of both antiseptic agents produced no significant result (P = 0.3). The sum score of tolerability produced a better result for povidone iodine. In addition, the drop in the pH value after observed antisepsis with povidone iodine provides an additional protective mechanism against bacterial colonization.

Administration, Cutaneous↗
PubMed1995

[Efficacy of various methods for preoperative vaginal antisepsis].

In a prospective clinical study we investigated 115 patients prior to vaginal surgical interventions to determine the antimicrobial efficacy of six different procedures for vaginal antisepsis. To sample the microorganisms we used a cotton swab moistened with a neutralising fluid. Immediately after the time of action of the antiseptic procedures (3 minutes), providone-iodine solution, applied undiluted or diluted 1:10, yielded the strongest median reduction of the vaginal flora (log RF 3.60 and 2.68, respectively). Of three detergents with antiseptic efficacy, octenidine 0.1% was the most efficient formula (log RF 2.32). After 30 minutes the log reduction factors (log RF) of almost all procedures (log RF 2.79-3.25) were in a fairly close range, excepting chlorohexidine 0.05% (log RF 2.07). Overall, the antiseptic detergents showed a marked residual effect, which was less pronounced, if at all, with providone-iodine solutions. A germ-reducing effect of povidone-iodine vaginal suppositories, applied 2 to 3 hrs prior to surgery, was not confirmed, while additional findings indicated that providone-iodine solution applied with the help of a vaginal douche yields a similarly strong germ reduction as the application by means of a ball swabs.

Adult↗
PubMed1989

Topical iodine-containing antiseptics and neonatal hypothyroidism in very-low-birthweight infants.

The thyroid function of very-low-birthweight (VLBW; below 1500 g) infants admitted to neonatal intensive-care units was studied at two hospitals; one routinely used topical iodinated antiseptic agents and the other used chlorhexidine-containing antiseptics. Serial monitoring of urinary iodine excretion and serum thyrotropin and thyroxine levels was undertaken from birth for the first 4 weeks of life. Urinary iodine excretion rose dramatically in the 54 iodine-exposed infants and was up to fifty times greater than in the 29 non-exposed infants. Within 14 days, 25% (9 of 36) of the infants exposed to iodine had serum thyrotropin levels above 20 mIU/l, compared with none of the control group. The mean serum thyroxine level in these 9 infants (44.1 nmol/l) was significantly lower than that in exposed infants with normal thyrotropin levels (83.1 nmol/l) and in the non-exposed control group (83.0 nmol/l); thyroxine levels fell before serum thyrotropin rose. These disturbances in thyroid function correlated positively with urinary iodine excretion and hence iodine absorption. Thyroid function had returned to normal by the time of discharge from hospital. It is concluded that iodine absorption, from topical iodine-containing antiseptics, may cause hypothyroidism during a critical period of neurological development in the newborn infant. The routine use of iodine antisepsis in VLBW infants should be avoided because of this effect.

Administration, Topical↗
PubMedDate not supplied

A clinical study comparing the skin antisepsis and safety of ChloraPrep, 70% isopropyl alcohol, and 2% aqueous chlorhexidine.

ChloraPrep (2% chlorhexidine gluconate + 70% isopropyl alcohol [CHG + IPA] in a 3.0-mL applicator) is a recently approved antiseptic for preoperative skin preparation. This controlled open-label trial assessed the immediate and persistent antimicrobial efficacy and safety of CHG + IPA compared with 70% IPA or a 2% CHG aqueous solution alone. Each antiseptic significantly reduced abdominal and inguinal microbial counts from baseline at 10 minutes, 6 hours, and 24 hours (P =.0001). CHG + IPA provided significantly more persistent antimicrobial activity on abdominal sites than IPA (P =.003) or CHG (P =.028) at 24 hours. No skin irritations were reported for any of the three antiseptics.

2-Propanol↗
PubMed2006

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.

Disinfectants↗
PubMed2002

Hand-rubbing with an aqueous alcoholic solution vs traditional surgical hand-scrubbing and 30-day surgical site infection rates: a randomized equivalence study.

CONTEXT: Surgical site infections prolong hospital stays, are among the leading nosocomial causes of morbidity, and a source of excess medical costs. Clinical studies comparing the risk of nosocomial infection after different hand antisepsis protocols are scarce. OBJECTIVE: To compare the effectiveness of hand-cleansing protocols in preventing surgical site infections during routine surgical practice. DESIGN: Randomized equivalence trial. SETTING: Six surgical services from teaching and nonteaching hospitals in France. PATIENTS: A total of 4387 consecutive patients who underwent clean and clean-contaminated surgery between January 1, 2000, and May 1, 2001. INTERVENTIONS: Surgical services used 2 hand-cleansing methods alternately every other month: a hand-rubbing protocol with 75% aqueous alcoholic solution containing propanol-1, propanol-2, and mecetronium etilsulfate; and a hand-scrubbing protocol with antiseptic preparation containing 4% povidone iodine or 4% chlorhexidine gluconate. MAIN OUTCOME MEASURES: Thirty-day surgical site infection rates were the primary end point; operating department teams' tolerance of and compliance with hand antisepsis were secondary end points. RESULTS: The 2 protocols were comparable in regard to surgical site infection risk factors. Surgical site infection rates were 55 of 2252 (2.44%) in the hand-rubbing protocol and 53 of 2135 (2.48%) in the hand-scrubbing protocol, for a difference of 0.04% (95% confidence interval, -0.88% to 0.96%). Based on subsets of personnel, compliance with the recommended duration of hand antisepsis was better in the hand-rubbing protocol of the study compared with the hand-scrubbing protocol (44% vs 28%, respectively; P =.008), as was tolerance, with less skin dryness and less skin irritation after aqueous solution use. CONCLUSIONS: Hand-rubbing with aqueous alcoholic solution, preceded by a 1-minute nonantiseptic hand wash before each surgeon's first procedure of the day and before any other procedure if the hands were soiled, was as effective as traditional hand-scrubbing with antiseptic soap in preventing surgical site infections. The hand-rubbing protocol was better tolerated by the surgical teams and improved compliance with hygiene guidelines. Hand-rubbing with liquid aqueous alcoholic solution can thus be safely used as an alternative to traditional surgical hand-scrubbing.

Anti-Infective Agents, Local↗
PubMed2006

Safety and impact of chlorhexidine antisepsis interventions for improving neonatal health in developing countries.

Affordable, efficacious, and safe interventions to prevent infections and improve neonatal survival in low-resource settings are needed. Chlorhexidine is a broad-spectrum antiseptic that has been used extensively for many decades in hospital and other clinical settings. It has also been given as maternal vaginal lavage, full-body newborn skin cleansing, and/or umbilical cord cleansing to prevent infection in neonates. Recent evidence suggests that these chlorhexidine interventions may have significant public health impact on the burden of neonatal infection and mortality in developing countries. This review examines the available data from randomized and nonrandomized studies of chlorhexidine cleansing, with a primary focus on potential uses in low-resource settings. Safety issues related to chlorhexidine use in newborns are reviewed, and future research priorities for chlorhexidine interventions for neonatal health in developing countries are discussed. We conclude that maternal vaginal cleansing combined with newborn skin cleansing could reduce neonatal infections and mortality in hospitals of sub-Saharan Africa, but the individual impact of these interventions must be determined, particularly in community settings. There is evidence for a protective benefit of newborn skin and umbilical cord cleansing with chlorhexidine in the community in south Asia. Effectiveness trials in that region are required to address the feasibility of community-based delivery methods such as incorporating these interventions into clean birth kits or training programs for minimally skilled delivery assistants or family members. Efficacy trials for all chlorhexidine interventions are needed in low-resource settings in Africa, and the benefit of maternal vaginal cleansing beyond that provided by newborn skin cleansing needs to be determined.

Anti-Infective Agents↗