Most chronic wounds are related to comorbidities, for which no clinical trials are performed. This retrospective propensity matched-cohort study examined data from 2 074 000 lower extremity wounds across 644 institutions to determine the effectiveness of TheraSkin plus standard of care (SOC; n = 1997) versus SOC alone (n = 1997). Multivariate modelling comparing outcomes such as healing rates, percent area reductions (PARs), amputations, recidivism, treatment completion, and medical transfers were evaluated. A higher proportion of wounds in the treatment group compared with the controls were more likely to close (68.3% versus 60.3%), particularly wounds with exposed structures (64% versus 50.4%) and with lower recidivism at 6 months (24.9% versus 28.3%). The control group was 2.75x more likely to require amputation than the treatment group. The combination of propensity matching and logistic regression analysis on a particularly large database demonstrated that wounds treated with TheraSkin had higher healing rates, higher PARs (78.7% versus 68.9%), fewer amputations, lower recidivism, higher treatment completion (61.0% versus 50.6%), and lower medical transfers (16.1% versus 23.5%) than SOC alone. This study considered data from complex wounds typically excluded from controlled trials and supports the idea that real-world evidence studies can be valid and reliable.
Abiosensor is an analytical device that uses a biological molecule to measure a biological or chemical reaction through electrical signals proportional to the concentration of an analyte in the reaction (Fig. 1). 1 Biosensors are used for clinical diagnostics, point-of-care (POC) testing, monitoring disease progression, drug discovery, detection of oncologic biomarkers, analysis of bodily fluids, and cardiac monitoring. 1 The purpose of this report is to describe the components that constitute a biosensor and outline the history of biosensors, clinical applications, applications specific to plastic surgery, and future uses for this technology.The sensor detects the analyte; the bioreceptor is a biological molecule that recognizes the analyte, and can be a cell, organelle, aptamer, enzyme, nucleic acid, or antibody. The bioreceptor binds with the analyte, causing an energy conversion by the transducer, which produces a quantifiable signal. The signal may be optical, electrical, thermal, or piezoelectric, and may change in pH or change in charge. The strength of the signal is dependent on the strength of the analyte-bioreceptor interaction. The electronic component of the biosensor processes the signal and converts it into a digital form that is quantified by the display, creating a numeric, graphic, or tabular output. 1 Compared with mass spectrometry and liquid chromatography, biosensors are advantageous because they are rapid, are portable, may be miniaturized using microfluidics, have high sensitivity and specificity for the analytes they sense, and are less costly and less toxic. 2 In 1906, M. Cremer demonstrated that the concentration of an acid in a liquid is proportional to the electric potential that rises between parts of the fluid located on opposite sides of the glass membrane, laying the foundation for modern-day biosensors. 1 The development of an electrode for pH measurement by W.S. Hughes in 1922 was the next step, and the first biosensor was developed by Leland C. Clark, Jr., in 1956 for the purpose of oxygen detection. 1,3 In 1962, Clark and Lyons developed the amperometric oxygen electrode, which monitored oxygen consumption through the oxidation-reduction reaction involving glucose oxidase and glucose. 4 Glucose concentration is measured by an increase in hydrogen peroxide or decrease in oxygen, which are both inversely proportional to glucose content. This biosensor became the basis of modern-day glucose sensing. It was acquired by the Yellow Spring Instrument Company, which developed the first commercial biosensor for the detection of blood glucose concentration in 1975. Following the successful invention of a glucose biosensor, Guilbault and Montalvo Jr. developed a potentiometric biosensor to detect urea in 1969.Summary: A biosensor uses a biological molecule to measure a chemical reaction. Wearable biosensors that attach to the body externally, including tooth enamel biosensors, contact lens biosensors, sweat biosensors, and skin tattoo biosensors, are in development. Nanoparticle-based b...
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