Wound cleaning and wound healing: a concise review.

Chronic wounds present a significant societal burden in their cost of care, and they reduce patient quality of life. Key components of wound care include such measures as debridement, irrigation, and wound cleaning. Appropriate care removes necrotic tissue and reduces wound bioburden to enhance wound healing. Physical cleaning with debridement and irrigation is of documented efficacy. Wounds may be washed with water, saline, or Ringer's solution or cleaned with active ingredients, such as hydrogen peroxide, sodium hypochlorite, acetic acid, alcohol, ionized silver preparations, chlorhexidine, polyhexanide/betaine solution, or povidone-iodine--the majority of which are locally toxic and of limited or no proven efficacy in enhancing wound healing. Although the consensus opinion is that these topical cleaning agents should not be routinely used, recent clinical evidence suggests that polyhexanide/betaine may be nontoxic and effective in enhancing wound healing. Further well-designed studies are needed.

A Study on the Application and Use of Artificial Intelligence to Support Drug Development.

PURPOSE: The Tufts Center for the Study of Drug Development (CSDD) and the Drug Information Association (DIA) in collaboration with 8 pharmaceutical and biotechnology companies conducted a study examining the adoption and effect of artificial intelligence (AI), such as machine learning, on drug development. The study was conducted to clarify and understand AI adoption across the industry and to gather detailed insights into the spectrum of activities included in the definition of AI. The study investigated and identified analytical platforms and innovations across pharmaceutical and biotechnology companies currently being used or planned for in the future. METHODS: A 2-part method was used that comprised in-depth interviews with AI industry experts and a global survey conducted across pharmaceutical and biotechnology organizations. Eleven in-depth interviews focused on use and implementation of AI across drug development. The survey assessed use of AI and included perceptions about current and future use. The survey also examined technology definitions, assessment of organizational and personal AI expertise, and use of partnerships. A total of 402 responses, including data from 217 unique organizations, were analyzed. FINDINGS: Although 7 in 10 respondents reported using AI in some capacity, a wide range of use was reported by AI type. Patient selection and recruitment for clinical studies was the most commonly reported AI activity, with 34 respondents currently using AI for this activity. In addition, identification of medicinal products data gathering was the top activity being piloted or in the planning stages, reported by 49 respondents. The study also revealed that the most significant challenges to AI implementation included staff skills (55%), data structure (52%), and budgets (49%). Nearly 60% of respondents noted planned increases in staff within 1-2 years to support AI use or implementation. IMPLICATIONS: Despite the challenges to AI implementation, the survey revealed that most organizations use AI in some capacity and that it is important to the success of an organization's workforce. Many organizations reported expectations for increasing staff as implementation of AI expands. Further research should examine the changing development landscape as the role of AI evolves.

Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries: Twelve-Month Results of the SUPERB Trial.

BACKGROUND: Stent-based therapy in the superficial femoral and popliteal arteries in patients with peripheral artery disease is compromised by restenosis and risk of stent fracture or distortion. A novel self-expanding nitinol stent was developed that incorporates an interwoven-wire design (Supera stent, IDEV Technologies, Inc, Webster, TX) to confer greater radial strength, flexibility, and fracture resistance. METHODS AND RESULTS: This prospective, multicenter, investigational device exemption, single-arm trial enrolled 264 patients with symptomatic peripheral artery disease undergoing percutaneous treatment of de novo or restenotic lesions of the superficial femoral or proximal popliteal (femoropopliteal) artery. Freedom from death, target lesion revascularization, or any amputation of the index limb at 30 days (+ 7 days) postprocedure was achieved in 99.2% (258/260) of patients (P < 0.001). Primary patency at 12 months (360 ± 30 days) was achieved in 78.9% (180/228) of the population (P < 0.001). Primary patency by Kaplan-Meier analysis at 12 months (360 days) was 86.3%. No stent fracture was observed by independent core laboratory analysis in the 243 stents (228 patients) evaluated at 12 months. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford-Becker category in 88.7% of patients. CONCLUSIONS: The SUPERB Trial, an investigational device exemption study using an interwoven nitinol wire stent in the femoropopliteal artery, achieved the efficacy and safety performance goals predesignated by the Food and Drug Administration. On the basis of the high primary patency rate, absence of stent fracture, and significant improvements in functional and quality-of-life measures, the Supera stent provides safe and effective treatment of femoropopliteal lesions in symptomatic patients with peripheral artery disease. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00933270.

Accidental intravenous infusion of air: a concise review.

The unintended intravenous infusion of small volumes of air is common in clinical practice. International Electrotechnical Commission guidelines for infusion pumps permit infusion of up to 1 mL in 15 minutes and discount bubbles smaller than 50 µL. A review of the literature, however, suggests that these limits may be too generous. Neonates and patients with right-to-left cardiac shunts (eg, patent foramen ovale [PFO]) are at risk from lower volumes. Because PFO is prevalent in 20% to 27% of healthy adults and generally asymptomatic, all patients are at risk from small air bubbles, although clinically significant air embolism from intravenous infusion is rare. Attention to good clinical practice and use of an inline air filter should be considered to reduce any risk.

The effect of a wound care solution containing polyhexanide and betaine on bacterial counts: results of an in vitro study .

Polyhexanide and betaine topical solution is used in the management of infected wounds as a cleaning agent. An in vitro study was conducted to examine the antimicrobial effects of a solution containing 0.1% of the antimicrobial agent polyhexanide and 0.1% of the surfactant betaine. Three batches of each product were tested, and culture results of 13 microorganisms were evaluated after 7, 14, and 28 days using USP <51> methodology. Growth reduction was identical at each day following exposure to the solution in all micro-organisms except Aspergillus brasiliensis. A range of 5.3-log to 5.8-log reduction was seen for the following micro-organisms: Staphylococcus epidermidis, Pseudomonas aeruginosa, Serratia marcescens, Candida albicans, S. aureus, vancomycin-resistant Enterococcus faecalis, Proteus mirabilis, Escherichia coli, methicillin-resistant S. aureus, Acinetobacter baumannii, Enterobacter cloacae, and E. faecalis. For A. brasiliensis, reductions were 2.1-log, 2.3-log and 2.8-log at 7, 14, and 28 days, respectively. The results of this study indicate a 4+ log inhibition of activity in 12 of 13 micro-organisms exposed to the solution. Research to elucidate the potential clinical effects of these observations is needed.