A range of factors must be considered when developing a topical antimicrobial for use in a healthcare personnel handwash, surgical scrub, or preoperative skin preparation. Antimicrobial effectiveness, low skin irritation, ease of use, and pleasing aesthetics are all essential if the product is to succeed. In addition, all facets of the product must comply with stringent regulatory requirements. With updated protocols and research, Topical Antimicrobials Testing and Evaluation, Second Edition comprehensively presents and reviews the latest techniques for testing antimicrobial compounds for effectiveness and regulatory compliance.
- The anatomical structure of the skin and skin microbiology relevant to product testing
- Use of antimicrobial products against specific microorganisms such as Staphylococcus and Streptococcus species
- Measurement of antimicrobial action of topical antimicrobials from experimental design, microbiological, biostatistical, and marketplace perspectives
- Various aspects of the topical antimicrobial products currently in common use in medical, food service, and consumer markets
- Statistical analysis and specific statistical designs for clinical trials
- Epistemological requirements in evaluating the effects of specific treatments
- Evaluation strategies and sample working protocols for hand and body soaps, food-handler antimicrobial products, and medical/healthcare industry antimicrobial products
The book is designed to inform industry and academia on the requirements to get products approved by the FDA and to market while also providing critical insight on ways to best service expanding markets.
Table of Contents
General Approach to Developing Topical Antimicrobials. Business. Quality Assurance. Moving Quality Control Outward. A Tighter Approach to Delivering a Useful Product. The Quadrant Model. A Recurring Problem: Reductionism. Skin Properties. Structure. Epidermis. Dermis. Dermal Vascularization. The Tissue Fluids. Skin Microbiology. Etiology of Infectious Diseases. Bacterial Cell. Mycology (Fungi). Specific Microorganisms. Staphylococcus. Streptococcus. Other Microorganisms. Fungi. Viruses. Measurement of Antimicrobial Action of Topical Antimicrobials. General Performance Characteristics. Current Topical Antimicrobials. Iodine Complexes. Chlorhexidine Gluconate. Tinctures of CHG and Alcohol. Parachlorometaxylenol. Alcohols Triclosan. Quaternary Ammonium Compounds. General Statistics. Sample Size Determination. What Type of Analysis Should I Use to Ensure the Study. Specific Statistical Designs for Clinical Trials. Preoperative Skin Preparation. Epistemological Requirements in Evaluating the Effects of Specific Treatments. Experimental Strategy. Choice of Qualitative or Quantitative Methods. Statistical Models. Statistical Model-Building and Analysis: Exploratory Phase. Statistical Model Selection. Parametric Statistics. Nonparametric Statistics. Qualitative Research Designs. Phenomenological Designs. Heuristic Designs. Historical Research Design. Evaluative Research Design. Evaluation Strategies and Sample Working Protocols. Consumer Antimicrobial Products. Antimicrobial Efficacy Studies. Sample Protocol: Healthcare Personnel Handwash. Evaluations. General-Use Handwash Evaluation. Medical/Healthcare Industry Antimicrobials. References. Index.
Daryl S. Paulson, Ph.D., a decorated Vietnam combat veteran, counselor in trauma-associated disorders, and President/CEO of BioScience Laboratories, Inc., has advanced degrees in microbiology, statistics, counseling, human science, and psychology. He has authored numerous articles and 14 books, including Biostatistics and Microbiology: A Survival Manual (Springer, 2009), Applied Statistical Designs for the Researcher (Marcel Dekker, 2003), Handbook of Topical Antimicrobial Testing and Evaluation, Competitive Business, Caring Business: An Integral Perspective for the 21st Century (Paraview Press, 2002), and Haunted by Combat: Understanding PSTD in War Veterans (Greenwood Publishing, 2007). Address correspondence to Daryl S. Paulson, 1765 South 19th Avenue, Bozeman, Montana 59718, or [email protected]