Antimicrobial efficacy of a very stable hypochlorous acid formula compared with other antiseptics used in treating wounds: in-vitro study on micro-organisms with or without biofilm.

BACKGROUND: Many antiseptics have been used to treat wounds. AIM: To compare the microbicidal efficacy of ClHO (Clortech®) with other antiseptics used on wounds, healthy skin and mucous membranes. METHODS: The microbicidal efficacy of 13 antiseptic products on eight micro-organisms (three Gram-positive; three Gram-negative; two yeasts) inoculated on organic germ-carriers was studied. In addition, the loss of efficacy against Staphylococcus aureus and Pseudomonas aeruginosa with biofilm was assessed with the six best-performing products. FINDINGS: Chlorhexidine (1%) had the highest microbicidal effect at 1 min. At 5 min, 500 and 1500 mg/L ClHO showed similar, or better, activity than the other antiseptics studied. The ClHO concentration of 300 mg/L achieved this same efficacy at 10 min. The product that lost the most efficacy due to biofilm was 1% chlorhexidine, while 1% PVP-I and ClHO at either 300 or 500 mg/L were moderately affected by biofilm. The most effective in the presence of biofilm was ClHO at 1500 mg/L. CONCLUSIONS: ClHO at medium-low concentrations (300 or 500 mg/L) is a good antiseptic that can be used on wounds and mucous membranes for 5-10 min. Lower concentrations of ClHO, as well as of the other antiseptics studied, were less effective or more altered by the biofilm. ClHO at a concentration of 1500 mg/L is very effective in the presence or absence of biofilm that can be used on healthy skin for 5 min.

Types of antiseptics, presentations and rules of use. / Tipos de antisépticos, presentaciones y normas de uso.

Antiseptics are chemical substances that when applied topically onto intact skin, mucous membranes or wounds partially or completely reduces the population of living microorganisms in those tissues. Different types of antiseptics are available - those most commonly used in clinical practice being alcohols, iodinated compounds and chlorhexidine. When using an antiseptic, consideration is required of its spectrum of antimicrobial activity, latency, residual effects, possible interferences of the presence of organic material with the activity of the antiseptic, its side effects, compatibility with other antiseptics, and cost. This article is part of a supplement entitled "Antisepsis in the critical patient", which is sponsored by Becton Dickinson.

Principles of Wound Management and Wound Healing in Exotic Pets.

The care of wounds in exotic animal species can be a challenging endeavor. Special considerations must be made in regard to the animal's temperament and behavior, unique anatomy and small size, and tendency toward secondary stress-related health problems. It is important to assess the entire patient with adequate systemic evaluation and consideration of proper nutrition and husbandry, which could ultimately affect wound healing. This article summarizes the general phases of wound healing, factors that affect healing, and principles of wound management. Emphasis is placed on novel methods of treating wounds and species differences in wound management and healing.

Antiseptics for treating infected wounds: Efficacy on biofilms and effect of pH.

Biofilm recalcitrance is a persistent problem when managing difficult to heal and infected chronic wounds. The wound biofilm is a fundamental factor in the re-occurrence and delayed healing commonly observed in non-healing and infected chronic wounds. However, there is presently no single antimicrobial agent that is completely efficacious against both the planktonic and sessile polymicrobial communities evident in at risk or infected wounds. We will review currently available antimicrobials, with particular emphasis on silver and iodine, employed to help suppress biofilms in wounds. In addition, we will also review the effect of pH on antimicrobial efficacy. Available evidence suggests that it is best to take a multifactorial approach towards controlling biofilm in chronic, "at risk" and infected wounds. This highlights the growing importance of avoiding indiscriminate or inappropriate use of antimicrobials in the treatment of chronic wounds.

[Microbicides for preventing sexually transmitted infections: Current status and strategies for preclinical evaluation of new candidates]. / Microbicidas para la prevención de infecciones de transmisión sexual: estado actual y estrategias para la evaluación preclínica de nuevos candidatos.

Microbicides are a new tool, still under investigation, which could help prevent infection by the human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs). Increasing evidence shows that the complexity of sexual transmission of viral pathogens requires the identification of compounds able to block the early events during the cycle of viral infection. In this manuscript we provide a comprehensive review of the different microbicide strategies that have been studied or are currently being considered for STI prevention, particularly emphasizing those having the potential to block HIV infection. The manuscript also reviews the complex process that is required to conduct future clinical studies in humans and concludes with a brief discussion of the strategies that could be part of the immediate future in microbicide research.

Introducción a los antisépticos / Introduction to antiseptics

Los antisépticos son agentes antiinfecciosos de uso local sobre piel o mucosas, lo cual los distingue de los desinfectantes, que se usan sobre superficies inanimadas, debido normalmente a su toxicidad. En este capítulo explicamos las diferencias entre los múltiples posibles antisépticos, prestando especial atención a los más comunes como el alcohol, la clorhexidina, la povidona yodada y el agua oxigenada. Finalmente hacemos hincapié en las diferentes formulaciones de los antisépticos, que los hacen más útiles para indicaciones determinadas

Antiseptics are anti-infectious agents for local use on the skin or mucosa, which distinguishes them from disinfectants, which are used on inanimate surfaces usually because of their toxicity. The present article explains the differences among the multiple possible antiseptics; special attention is paid to the most common, such as alcohol, chlorhexidine, povidone iodine, and oxygenated water. Finally, we stress the different antiseptic formulations, which increase the usefulness of these agents in specific indications

Microbicidas para la prevención de infecciones de transmisión sexual: estado actual y estrategias para la evaluación preclínica de nuevos candidatos. / [Microbicides for preventing sexually transmitted infections: Current status and strategies for preclinical evaluation of new candidates].

Microbicides are a new tool, still under investigation, which could help prevent infection by the human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs). Increasing evidence shows that the complexity of sexual transmission of viral pathogens requires the identification of compounds able to block the early events during the cycle of viral infection. In this manuscript we provide a comprehensive review of the different microbicide strategies that have been studied or are currently being considered for STI prevention, particularly emphasizing those having the potential to block HIV infection. The manuscript also reviews the complex process that is required to conduct future clinical studies in humans and concludes with a brief discussion of the strategies that could be part of the immediate future in microbicide research.

Contemporary perspective on plaque control.

The aim of this review article is to provide a scientific platform that will enable the dental team to develop a rational approach to plaque control based on the latest knowledge of the role of the oral microflora in health and disease. The resident oral microflora is natural and forms spatially-organised, interactive, multi-species biofilms on mucosal and dental surfaces in the mouth. These resident oral microbial communities play a key function in the normal development of the physiology of the host and are important in preventing colonisation by exogenous and often undesirable microbes. A dynamic balance exists between the resident microflora and the host in health, and disease results from a breakdown of this delicate relationship. Patients should be taught effective plaque control techniques that maintain dental biofilms at levels compatible with oral health so as to retain the beneficial properties of the resident microflora while reducing the risk of dental disease from excessive plaque accumulation. Antimicrobial and antiplaque agents in oral care products can augment mechanical plaque control by several direct and indirect mechanisms that not only involve reducing or removing dental biofilms but also include inhibiting bacterial metabolism when the agents are still present at sub-lethal concentrations.

Controlling the oral biofilm with antimicrobials.

The aim of this article is to review the properties of compounds available for the control of dental plaque biofilms, and describe their mode of action. The mouth is colonised by a diverse but characteristic collection of micro-organisms, which confer benefit to host. Numerous antiplaque (e.g. surfactants, essential oils) and antimicrobial agents (e.g. bisbiguanides, metal ions, phenols, quaternary ammonium compounds, etc.) have been successfully formulated into toothpastes and mouthrinses to control plaque biofilms. At high concentrations, these agents can remove biofilm and/or kill disease-associated bacteria, while even at sub-lethal levels they can inhibit the expression of pathogenic traits. Successful antimicrobial agents are able to meet the apparently contradictory requirements of maintaining the oral biofilm at levels compatible with oral health but without disrupting the natural and beneficial properties of the resident oral microflora.

Treatment protocols: nonfluoride management of the caries disease process and available diagnostics.

This article reviews the evidence for saliva diagnostics and some antibacterial concepts with potential to interfere with the caries process. It concludes that there is incomplete evidence to evaluate the role of chair-side tests and to recommend general topical applications of antibacterial agents to prevent caries lesions. However, such measures may be considered to control the disease in caries-active individuals. There is evidence that xylitol has antibacterial properties that alter the oral ecology but the clinical evidence for caries prevention is rated as fair. However, preventive programs should include as many complementary strategies as possible, especially when directed toward caries-active patients. Therefore, any antibacterial intervention should always be combined with a fluoride program, until stronger evidence for its use in caries prevention and management becomes available.

Willingness to use microbicides is affected by the importance of product characteristics, use parameters, and protective properties.

BACKGROUND: Along with efficacy, a microbicide's acceptability will be integral to its impact on the pandemic. Understanding Product Characteristics that users find most acceptable and determining who will use which type of product are key to optimizing use effectiveness. OBJECTIVES: To evaluate psychometrically the Important Microbicide Characteristics (IMC) instrument and examine its relationship to willingness to use microbicides. RESULTS: Exploratory and confirmatory factor analyses revealed 2 IMC subscales (Cronbach's coefficient alpha: Product Characteristics subscale (alpha = 0.84) and Protective Properties subscale (alpha = 0.89)). Significant differences on Product Characteristics subscale scores were found for history of douching (P = 0.002) and employment status (P = 0.001). Whether a woman used a method to prevent pregnancy or sexually transmitted disease (STD) in the last 3 months (P < 0.001) and whether she used a condom during the last vaginal sex episode (P < 0.001) were significantly related to her rating of the importance of microbicides being contraceptive. Product Characteristics (r = 0.21) and Protective Properties (r = 0.27) subscale scores and whether a microbicide had contraceptive properties (r = 0.24) were all significantly associated (P < 0.001) with willingness to use microbicides. CONCLUSIONS: Formulation and use characteristics and product function(s) affect willingness to use microbicides and should continue to be addressed in product development. The IMC instrument serves as a template for future studies of candidate microbicides.

A review of anti-septic agents for pre-operative skin preparation.

Pre-operative skin preparation of the surgical site using appropriate anti-septic product is recognized by the Centers for Disease Control and Prevention Guideline for Prevention of Surgical Site Infection, 1999, as a strongly recommended intervention to prevent surgical site infection. This article reviews anti-septic surgical skin preparation products according to the Food and Drug Administration classifications, efficacy, and safety. It also examines pertinent research regarding anti-septic products. This information provides the peri-operative registered nurse with information to make appropriate decisions when choosing anti-septic skin preparation products for surgical patients.

The classification of antiseptic products to be administered to wounds--another borderline case between medicinal products and medical devices?

The importance of a correct demarcation between a Medicinal Product (MP) and a Medical Device (MD) is undisputedly one of the major topics related to the development and launch of a new healthcare product. However, for some products the correct demarcation between MPs and MDs can turn out to be somewhat complicated. This article aims to provide an overview on the existing legislation and its adequate application based on a suitable example at hand. Article 2 (2) of the European Directive 2001/83/EC as amended by Directive 2004/27/EC on the Community code relating to medicinal products for human use stipulates that the respective Medicinal Products Legislation must be applied whenever a product can be covered by both the definitions for MPs and for products regulated by other legal provisions enacted by the European Community, e.g. Cosmetic Products (CPs) or MDs. This basic principle implies that the decision to base the risk-benefit assessment of the product in question on the Medical Device Directive (MDD) would contradict the aforementioned constitutional principle, pursuant to which the stricter of the regulatory procedures theoretically possible is to apply in cases of doubt. In contrast to the approval procedure established for MPs, the MDD requires a Conformity Assessment Procedure to be performed by the manufacturer himself and a "Notified Body". Thus, in the majority of cases the responsibility for the risk assessment of MDs lies solely with the manufacturer and is prior to launch not subject to further scrutiny by regulators. Only in specific cases, i.e. for the Conformity Assessment Procedure of Class III MDs which contain an Active Pharmaceutical Ingredient one of the Member States competent authorities designated in accordance with Directive 65/ 65/EEC has to be involved before taking a decision. It is therefore important that the classification of the product is carried out carefully in full compliance with existing legal provisions, also taking into account the related guidance documents issued by the European Commission. The adequate application of these rules is explained using the example of the antiseptic compound polihexanide, which is used both in approved medicinal products (wound antiseptics) and wound irrigation solutions labelled as medical devices.

Frequently asked questions (FAQ).

As Americans use botanical medicines in ever-increasing numbers, they are moving beyond capsules and tinctures, and turning to assorted preparations that will complete their herbal medicine chest. According to The Arthritis Foundation, almost 45% of patients apply ointments or rubs for osteoarthritis. Topical preparations have a long history in traditional herbal medicine systems, and make up a significant proportion of the armamentarium of indigenous practitioners. Although contemporary patients are often resistant to the inconvenience of topical preparations, they often will become compliant after a notable success. The nomenclature of these topical preparations, as one would expect, is murky. There are no clear and consistent definitions for the assorted terms, and different sources will use different terms for the same material or process.

An economic evaluation of two ototopical treatments for acute otitis media in tympanostomy tube patients.

OBJECTIVE: The goal of this research was to determine the cost-effectiveness of ciprofloxacin 0.3%/dexamethasone 0.1% (CD) otic suspension versus ofloxacin 0.3% otic solution (OFX) for treatment of acute otitis media in tympanostomy tube patients. METHODS: A decision-analytic model was used to emulate the ototopical treatment of acute otitis media in patients with tympanostomy tubes. The economic outcome was the cost per otorrhea-free day (OFD) achieved per episode of care. Three tiers of antimicrobial therapy were modeled, with each successive tier representing the retreatment of clinical failures from the preceding tier. First-tier therapy compared CD and OFX using outcome measures obtained from a randomized clinical trial (n = 599). Second-tier therapy modeled the use of amoxicillin/clavulanate (ACA) using outcome measures obtained from a physician survey and medical literature. Third-tier therapy was modeled as pathogen-specific and curative. It could follow one of three pathways: 1) intramuscular ceftriaxone; 2) oral fluconazole; or 3) hospitalization for intravenous antibiotics. Third-tier outcomes were based on a physician survey. Cost data were obtained from standard references and presented from a payer perspective. RESULTS: The expected therapeutic costs were 249.40 dollars for the CD pathway and 265.44 dollars for the OFX pathway. The estimated number of OFDs per episode of care was 25.88 for the CD pathway and 23.86 for the OFX pathway. The cost-effectiveness ratios for CD and OFX therapies were 9.64 dollars and 11.13 dollars per OFD, respectively. CONCLUSION: CD is both more effective and less costly than OFX for the treatment of acute otitis media in patients with tympanostomy tubes.

Topical antiseptics in healthcare.

Topical antiseptics are essential for infection control. Antiseptic formulations employ a variety of mechanisms, act at various rates and persistence intervals, demonstrate various levels of toxicity, and are more or less likely to trigger resistance. The desired characteristics are considered when selecting antiseptics for hand washing, surgical scrubbing, and patient preoperative skin preparation. The selection process requires evidence of product safety and efficacy. This article explores currently available topical antimicrobial agents used in medical settings.

A study of the potential of the pig as a model for the vaginal irritancy of benzalkonium chloride in comparison to the nonirritant microbicide PHI-443 and the spermicide vanadocene dithiocarbamate.

A porcine model was established to test the mucosal toxicity potential of a thiophene thiourea (PHI-443)-based anti-HIV microbicide and a vanadocene-based spermicide, vanadocene dithiocarbamate (VDDTC) in comparison to benzalkonium chloride (BZK). Nine domestic pigs (Duroc) in nonestrus stage received a single intravaginal application of 2% BZK, 2% PHI-443, or 0.1% VDDTC-containing gel. At various times after gel application, cell differentials and levels of inflammatory cytokines (IL-1beta, IL-4, IL-6, IL-8, IL-10, IL-18, IFN-gamma, and TNF-alpha) in cervicovaginal lavage (CVL) fluid were monitored by flow cytometry and ELISA, respectively. Eight pigs were exposed intravaginally to a gel with and without BZK or VDDTC for 4 consecutive days and vaginal tissues were scored histologically for inflammation using a new scoring system. Only CVL fluid from pigs exposed to BZK showed a significant increase of IL-1beta, IL-8, and also IL-18 production when compared to the controls, PHI-443 or VDDTC-treated groups. Maximum levels of BZK-induced IL-1beta (100-fold), IL-8 (2,500-fold), IL-18 (80-fold), and IFN-gamma (10-fold) were found at 24 hours. In the in vivo porcine vaginal irritation model, increased levels of vaginal IL-1beta, IL-8, and IL-18 were associated with histological changes consistent with vaginal inflammation. These results demonstrate that key cervicovaginal inflammatory cytokines are useful in vivo biomarkers for predicting the mucosal toxicity potential of vaginal products in the physiologically relevant and sensitive porcine model.

[Calcium hydroxide-based pastes used in endodontics]. / Les pâtes à base d'hydroxyde de calcium utilisées en endodontie.

The aim of the present study is to propose a classification of calcium hydroxide pastes on the basis of the vehicle that retains the calcium hydroxide. The vehicle determines the working characteristics of the calcium hydroxide: viscous and only vehicles prolong the action of the calcium hydroxide as compared with water-soluble substances. Physicochemical properties of the vehicle may limit the effectiveness in disinfecting the entire root canal system. As calcium hydroxide is not effective against all bacterial species found in root canal infections, associations with other medicaments have been proposed to enhance the efficacy of the intracanal medication.