The MIRA surgical robot's hand. (Craig Chandler/UNL)
In the near future, NASA and other space agencies will send astronauts beyond Low Earth Orbit (LEO) for the first time in over fifty years.
But unlike the Apollo Era, these missions will consist of astronauts spending extended periods on the Moon and traveling to and from Mars (with a few months of surface operations in between).
Beyond that, there's also the planned commercialization of LEO and cis-Lunar space, meaning millions of people could live aboard space habitats and surface settlements well beyond Earth.
This presents many challenges, which include the possibility that the sick and injured won't have licensed medical practitioners to perform potentially life-saving surgery.
To address this, Professor Shane Farritor and his colleagues at the University of Nebraska-Lincoln's (UNL) Nebraska Innovation Campus (NIC) have developed the Miniaturized In-vivo Robotic Assistant (MIRA).
In 2024, this portable miniaturized robotic-assisted surgery (RAS) platform will be flown to the International Space Station (ISS) for a test mission to evaluate its ability to perform medical procedures in space.
Farritor is the David and Nancy Lederer Professor of Engineering at the University of Nebraska who studied robotics at MIT. As part of his studies, he worked with the NASA Kennedy Space Center, Goddard Space Flight Center, and Jet Propulsion Laboratory in support of NASA's Mars Exploration Rover (MER) program.
This consisted of assisting in designing and assembling the Curiosity and Perseverance rovers, defining their motion planning, and inventing a process where the rover's Sun detectors are used to determine its direction of travel.
In 2006, he and Dmitry Oleynikov – a former University of Nebraska Medical Center (UNMC) professor of surgery – founded Virtual Incision, a startup company based at the NIC.
In April 2022, Farritor was named the inaugural winner of the Faculty IP Innovation and Commercialization Award – issued by the University of Nebraska for intellectual property.
For nearly 20 years, Farritor, Oleynikov, and their colleagues have been developing the MIRA robotic surgical suite, which has attracted over US$100 million in venture capital.
Recently, NASA awarded Virtual Incision a $100,000 grant through the US Department of Energy's (DoE) Established Program to Stimulate Competitive Research (EPSCoR) to help engineers and roboticists at the NIC prepare it for its test aboard the ISS.
Compared to conventional robotic surgical suites, MIRA offers two advantages. First, its instruments can be inserted through small incisions, allowing doctors to perform minimally-invasive operations (such as abdominal surgery and colon resections).
Second, the technology could allow for telemedicine, where surgeons can perform operations remotely and provide services to locations far from a medical facility. On Earth, this technology already allows doctors to assist people in faraway locations where services are not readily available.
However, the MIRA technology has the added benefit of performing operations autonomously, meaning that astronauts serving on the Moon and Mars could receive medical care without the need for a human surgeon.
Said John Murphy, CEO of Virtual Incision, in a accurate company press release:
"The Virtual Incision MIRA platform was designed to deliver the power of a mainframe robotic-assisted surgery device in a miniaturized size, with the goal of making RAS accessible in any operating room on the planet.
"Working with NASA aboard the space station will test how MIRA can make surgery accessible in even the most faraway places."
During the next year, Farritor will work with engineering graduate student Rachael Wagner to prep MIRA for operations aboard the ISS. Wagner began working with Farritor as an undergraduate student and took a position with Virtual Incision in 2018 after completing her bachelor's degree in mechanical engineering.
This will consist of writing software, configuring MIRA to fit inside an experiment locker, and testing the device to ensure it is rugged enough to survive being launched aboard a rocket and will function as needed in space.
In August 2021, MIRA successfully performed its first remote surgery as part of a clinical study under an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA).
The procedure – performed by Dr. Michael A. Jobst at the Bryan Medical Center in Lincoln, Nebraska – consisted of a right hemicolectomy (where one-half of the colon is removed) and was accomplished with a single incision within the naval.
Said Dr. Jobst: "The MIRA platform is a true breakthrough platform for general surgery, and it is extremely gratifying to be the first surgeon in the world to use the system.
"The procedure went smoothly, and the patient is recovering well. I'm excited to play a part in taking the first steps toward increasing access to robotically assisted surgery, which has clear benefits for patients."
In another experiment, former astronaut Clayton Anderson (a retired NASA astronaut) operated MIRA from the Johnson Space Center, directing it to perform surgery-like tasks in an operating room at the University of Nebraska Medical Center – located 1450 kilometers (900 miles) away.
During its upcoming test aboard the ISS, MIRA will operate autonomously without the help of a controller. For the sake of this test, the robot will cut tautly stretched rubber bands (simulating skin) and push metal rings along a wire (simulating delicate operations).
"These simulations are very important because of all the data we will collect during the tests," said Wagner in a Nebraska News release.
This test will be the most autonomous operation of the robot so far, which is intended to conserve space station communications bandwidth and minimize the time astronauts spend with the experiment.
However, the goal of this mission is not to demonstrate the robot's autonomy (which is still limited) but to fine-tune the robot's operation in zero gravity. These experiments will help validate the technology for future long-duration missions in and beyond LEO.
As Farritor said: "NASA has ambitious plans for long-duration space travel, and it's important to test the capabilities of technology that may be beneficial during missions measured in months and years.
"MIRA continues to push the boundaries of what's possible in RAS, and we are pleased with its performance so far during clinical trials. We're excited to take it a step further and help identify what could be possible in the future as space travel is becoming more of a reality for mankind."
As humans travel farther and farther from Earth, they will need to be as self-sufficient as possible. On the Moon, Mars, and other locations in deep space, resupply missions are impractical, as is flying doctors or patients to and from these locations.
This means that in addition to being able to grow their own food, utilize local resources to meet their needs (ISRU), rely on bioregenerative life support systems, and generate electricity locally, they will need to provide essential services like medical care and surgery.
This article was originally published by Universe Today. Read the original article.
That appeared to be the big message out of the Waltham, Massachusetts–based surgical robotics company’s Q2 earnings report yesterday evening.
Vicarious Surgical’s technology uses proprietary human-like surgical robots combined with 3D visualization to transport surgeons inside the patient to perform minimally invasive surgery. CEO Adam Sachs noted during the company’s earnings call that updates to the previous Beta 1 system are focusing on ergonomic changes for surgeon comfort — and improved 3D visualization, sensing and motion capabilities. The idea is to enable the surgeon to move freely within the abdominal cavity with the system, he said.
“With significant and very positive feedback on the initial Beta 2 ergonomic prototypes, we have completed the Beta 2 design, and we are beginning the integration phase of the build,” Sachs said during the call, transcribed by Seeking Alpha. “This is our next step towards bringing our robotics platform to market and ultimately demonstrating its capabilities through a cadaveric eventual hernia procedure in a hospital setting, which we plan to share greater details around later this year.”
A month ago, Vicarious Surgical signed collaborative Center of Excellence agreements with Nashville, Tennessee–based HCA Healthcare and its 182 hospitals across 20 U.S. states and the United Kingdom — as well as University Hospitals Ventures, the innovation and commercialization arm of University Hospitals (UH) in northern Ohio.
Sachs said the agreements go much deeper than mere post-market surgeon training; they represent collaboration throughout the extensive development, clinical, verification, validation and launch phases of Vicarious Surgical’s robotic system.
Despite the strides the company is making, Sachs acknowledged that Vicarious Surgical has experienced limited semiconductor supply and shortages of chips and other hardware in accurate months. “If these challenges continue, they can present a risk to our timeline.”
He added: “We continue to evaluate the details of our supply chain for opportunities to build internal redundancies and multi-source key components and enhance our product design to address constrained supply chain risk.”
For the quarter ended June 30, 2022, Vicarious Surgical saw an adjusted net loss of $19.1 million, or 16¢ per share. It was two pennies behind the 14¢ loss predicted by The Street. The company’s cash burn rate in Q2 was $15.7 million — with a projected full-year cash burn of $65 million to $75 million. The plan is to have roughly $100 million in cash and cash equivalents on hand by the end of the year.
BTIG analyst Ryan Zimmerman kept his Buy rating on Vicarious Surgical stock, even as he called out supply chain challenges as an unnecessary distraction: “We await RBOTs next clinical milestones, which include a potential demo of the system later this year at one of their Centers of Excellence.”
Investors reacted by sending RBOT shares down more than 8% to $4.06 apiece in after-hours trading.
The Research Triangle Park, North Carolina–based surgical robotics and digital surgery company lost $19.6 million, or 8¢ per share, off $994,000 in revenue for the quarter ended June 20, 2022 — versus a loss of $13.2 million, or 6¢ per share, off $1.1 million in revenue for the same quarter a year ago.
Wall Street analysts had expected EPS of –8¢ on $1.25 million in revenue.
During Q2, Asensus announced the installation of a Senhance system at the University Hospital Tübingen in Germany. The company also has two additional orders that have not yet been installed — including one heading toward one of the countries in the Commonwealth of Independent States, the international organization that includes Russia and many other former republics of the Soviet Union.
The company is seeking to expand the use of its Intelligent Surgical Unit (ISU). It plans a full-scale commercial launch of 5 mm articulating instruments and a 510(k) application for pediatric clearance, both during the second half of 2022.
“We delivered yet another strong quarter of global Senhance system utilization growth and made great progress towards the ongoing development of our digital surgery platform with the Intelligent Surgical Unit (ISU) as we seek to make performance-guided surgery (PGS) a reality,” Asensus Surgical CEO Anthony Fernando said in a news release. “Our goal is to enable surgeons to perform safer, more predictable, and better quality procedures. By delivering real-time, data-driven clinical intelligence and guidance, Senhance and PGS will revolutionize surgery, and most importantly, help to Excellerate patient outcomes.”
Investors reacted by sending ASXC shares up more than 4% to 59¢ apiece in after-hours trading.
A person considering an abortion may wonder about any effects on future pregnancies. In most cases, a previous abortion does not affect fertility and has no impact on other pregnancies. In rare cases, a previous abortion could lead to subsequent pregnancy complications.
There are two abortion methods: medical and surgical. The type of abortion a person has may depend on several factors, including how far along the pregnancy is and the person’s preference.
Research suggests that abortions do not affect fertility and that the risks associated with both types of abortion are relatively low.
This means a person can get pregnant soon after having an abortion. Anyone who does not wish to become pregnant within weeks of abortion should use contraception if they are engaging in sexual activities that could lead to pregnancy.
Most of the time, people who have had abortions can go on to have healthy pregnancies. In rarer cases, a person who has had an abortion could experience some complications in later pregnancy.
This article discusses fertility and pregnancy after an induced abortion, including safety factors and risks.
According to the American College of Obstetricians and Gynecologists (ACOG), having a previous pregnancy does not increase the risk of infertility after the procedure.
People who do become pregnant after an abortion may experience some pregnancy complications, but the risk of this is low.
In one study that included data on 54,911 abortions among 50,273 women, researchers found that complications occurred in only 2.1% of cases and serious complications occurred in 0.23% of cases.
Abortions are safest when they happen as early as possible in pregnancy. Complications are more likely when a pregnancy is farther along, regardless of the method of abortion.
Whether a person experiences complications and the degree of their severity may also depend on the type of abortion, a person receives.
A medical abortion involves taking medication, and medical professionals tend to use this method for abortions during the first trimester. A combination of the medications mifepristone and prostaglandin, for example, has a success rate of up to 99%.
A surgical abortion, also known as dilation and curettage (D&C), involves removing the fetus with suction and a tool called a curette.
One large cohort study found a positive association between a surgical termination of pregnancy and later pregnancy complications. These complications include preterm delivery, cervical insufficiency, placental retention, and heavy postpartum bleeding
In rare cases, a surgical abortion can cause scarring of the uterine wall. Doctors call this Asherman syndrome. Scarring may make it more difficult for a person to get pregnant again and may lead to pregnancy loss in the future.
The risks of medical abortion appear to be lower than those of surgical abortion, though this may be true only because medical abortions are more common during early pregnancy. Overall, having an abortion early in pregnancy reduces the risk of complications.
If complications arise, further treatment may be necessary to reduce the risk of future problems. A doctor can advise each individual about the risks.
Many doctors recommend waiting until the bleeding ends after either type of abortion before having sex again. Bleeding from an abortion can last for 2 weeks or more.
Other doctors advise waiting until at least one menstrual period has come and gone. Delaying sex will help reduce the risk of infection.
In some cases, it is necessary to delay having sex longer, especially if the abortion took place later in the pregnancy or if there were complications from the abortion procedure itself.
Ovulation can occur as soon as 2 weeks after an abortion. This means a person may become pregnant again before their next period. However, menstrual cycles vary in length, and people with shorter cycles may ovulate sooner.
Another factor that influences the timing of ovulation is the duration of the pregnancy before the abortion. If an abortion takes place later in the pregnancy, the person may not ovulate for several weeks afterward. This can occur when pregnancy hormones linger in the body.
A person who wants to avoid pregnancy soon after an abortion may want to use contraception. According to the ACOG, a person can use any contraceptive method, including an intrauterine device, immediately after pregnancy ends.
Anyone who wonders whether they have become pregnant soon after an abortion should take a pregnancy test. If the result is positive, they should see a doctor, who can determine whether there is a new pregnancy or whether leftover pregnancy hormones are present.
People can become pregnant within 2 weeks of an abortion. For those who are ready to get pregnant again, there is generally no medical reason to delay trying to conceive — unless a doctor advises otherwise.
A person does not need to take extra steps to become pregnant after an abortion.
However, some doctors recommend waiting until the first menstrual period has ended. This will make it easier to estimate the delivery date of the next pregnancy.
Those who have had abortions for medical reasons may want a full medical assessment before trying to conceive again. A checkup can help determine whether a person will experience similar issues with future pregnancies.
Shortly after an abortion, a pregnancy test may provide a false-positive result. This occurs because the body still contains significant levels of the hormone human chorionic gonadotropin (hCG).
While hCG levels tend to fall quickly after an abortion, they can take several days or weeks to return to baseline.
Usually, a home pregnancy test shows an accurate negative result 3 weeks after the end of a pregnancy.
If a pregnancy test shows a positive result after 3 weeks, it may indicate a new pregnancy. To be certain, a person should see a doctor who can carry out a blood test or an ultrasound.
In most cases, an abortion does not affect fertility or future pregnancies. It is possible to ovulate and become pregnant within 2 weeks after an abortion.
In rare cases, surgical abortion can cause scarring of the uterine wall or damage to the cervix. These complications may make it more difficult to get pregnant again. They can also increase the risk of future pregnancy loss, preterm birth, or low birth weight.
However, both medical and surgical abortions are low risk. The right method will depend on the stage of pregnancy and on a person’s preference. A medical professional can help with this decision.
Anyone who has questions or concerns about pregnancy after an abortion should consult a healthcare professional.
The Lee Health Surgical Optimization Center, located in the medical office building at Gulf Coast Medical Center, maximizes outcomes for patients undergoing orthopedic (total hip and total knee) surgeries. Based on the American Society of Anesthesiologists’ Perioperative Surgical Home (PSH) model, the Center aims to Excellerate surgical outcomes, use fewer resources, reduce hospital stays and readmissions, and decrease complications for patients referred there.
When a patient is referred to the Surgical Optimization Center, the staff assesses their family history, personal medical history, medications, current conditions, and screening or test results to help minimize the unknown risks of surgery. Following the assessment, the care team, often in conjunction with a primary care provider or specialist, provides patients with a personalized plan to prepare them for surgery. The plan may include suggestions for dietary changes, therapy, pain management and treatment for any underlying conditions.
“A good way to understand the process that the care team at the Surgical Optimization Center carries out is by comparing it to a coach preparing an athlete for a marathon,” says John Dunn, D.O., the anesthesiologist on the Lee Health Medical Staff who introduced the PSH model to our health system. “It is unlikely that an individual could run a marathon on a whim and successfully finish the race, so why should patients undergo body-straining, major surgery with no preparation? They shouldn’t, so the care team guides each patient to an optimal condition before surgery, which may take weeks or months of preparation, but ensures the best outcome.”
Created with high-risk surgeries in mind, there are benefits for any patient referred to the Center because the team is dedicated to each patient’s entire surgical journey, from beginning to end. The care team strives to:
Educate patients on self-care before and after surgery.
Create an organized discharge plan.
Minimize patient hospital stays.
Decrease recovery time for patients.
The Surgical Optimization Center is a great, tangible example of Lee Health’s mission of being a trusted partner, empowering healthier lives through care and compassion. I am so proud to have this level of personalized, truly empowering care in our community and available for our patients undergoing total knee and hip surgeries.
To learn more, visit LeeHealth.org and search “Surgical Optimization Center.”
More: Lee Health: New podcast – Be inspired to live a healthy life
More: Lee Health: Illnesses are circulating, care is available from home
Larry Antonucci, M.D., MBA is the president & CEO of Lee Health, Southwest Florida’s major destination for health care offering acute care, emergency care, rehabilitation and diagnostic services, health and wellness education, and community outreach and advocacy programs. Visit www.LeeHealth.org to learn more.
This article originally appeared on Naples Daily News: Lee Health: Surgical care team coaches patients toward safe surgeries
The MarketWatch News Department was not involved in the creation of this content.
Jul 28, 2022 (The Expresswire) -- To prosper in this competitive marketplace, businesses are highly benefited if they adopt innovative solutions such as theBowie Dick Test Pack Market Sizeresearch report. A number of estimations and calculations have been executed in this market report by assuming a definite base year and the historic year. The market document also provides the knowledge of all the drivers and restraints which are derived through SWOT analysis. The Bowie Dick Test Pack Marketreport considers various factors that have a great effect on the growth of the business which includes historic data, present market trends, environment, technological innovation, upcoming technologies, and the technical progress in the Healthcare industry.
The market is projected to grow from USD 178.7 million in 2021 to USD 254.6 million in 2028 at a CAGR of 5.2% in the 2021-2028 period.
Get a trial Copy of the Report at https://www.fortunebusinessinsights.com/enquiry/request-sample-pdf/105168
The Bowie Dick Test Pack Market is driven by the rising cases of male pattern baldness. The incidence of baldness among men has become common among men globally. The prevalence of the condition is increasing with rise in risk factors such as smoking, poor eating habits, stress, and deficiency of essential nutrients and minerals. The rising cases of baldness among men have increased the adoption of hair transplants, which, in turn, is driving the growth of the market.
Drivers and Restraints
There is an increase in the number of invasive surgical procedures for the treatment of various health conditions. During these procedures, the surgical instrument comes in contact with the tissue, increasing the risk of infection. To ensure patient safety, the surgical instruments,medical devices, and equipment must be adequately sterilized. According to the Association for the Advancement of Medical Instrumentation (AAMI) guidelines, it is compulsory to perform a Bowie Dick test for the steam penetration before starting loading.
The competitive landscape of the Bowie Dick Test Pack Market has been discussed in detail. The report highlights leading companies, their performance over the past few years, and their key strategies. The Bowie Dick Test Pack Market report provides a comprehensive evaluation of several factors that have contributed to the growth of the market in accurate years. In addition to the growth stimulators, the report also discusses the challenges facing the market. Furthermore, the report provides forecast values for the market for the period 2020-2029. Additionally, it identifies areas that have witnessed the highest demand and applications for the product in accurate years. Besides this, some of the leading products, major companies, and major accurate industry developments have been highlighted in this report.
Key players covered in the globalBowie Dick Test Pack Market research report:
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Table of Content:
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Fortune Business Insights™ delivers accurate data and innovative corporate analysis, helping organizations of all sizes make appropriate decisions. We tailor novel solutions for our clients, assisting them to address various challenges distinct to their businesses. Our aim is to empower them with holistic market intelligence, providing a granular overview of the market they are operating in.
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COMTEX_411212252/2598/2022-07-28T23:55:57
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Study: Plant-Based Synthetic Organs Prove Effective for Fluorescence-Guided Surgical Training
Aug 03, 2022 (PRNewswire via COMTEX) -- PR Newswire
YASHIO, Japan, Aug. 3, 2022
YASHIO, Japan, Aug. 3, 2022 /PRNewswire/ -- A new study on the effectiveness of plant-based organs for use in surgical training was performed by Dr. Naoki Nishio at the Nagoya University Graduate School of Medicine. The study was published in the Laryngoscope Investigative Otolaryngology Journal. In it, Dr. Nishio found that KOTOBUKI Medical's Versatile Training Tissue (VTT) provided a cost-effective and accurate practice model for near-infrared (NIR) fluorescence-guided tumor removal.
Near-infrared (NIR) fluorescence-guided surgery utilizes a fluorescent dye called ICG to mark tumors and lesions. This ensures a more thorough removal of cancerous tissue.
Dr. Nishio conducted his study at Nagoya University's Medical xR Center. There, he and his team performed tumor enucleation and resection surgeries on VTT, a synthetic plant-based tissue created by KOTOBUKI Medical. They used NIR fluorescence-guided surgical techniques with electrocautery scalpels and ICG dye.
In his study, Dr. Nishio wrote that VTT was an ideal simulator for NIR fluorescence-guided surgical training, as VTT models contain no plastics or chemicals that could create smoke when used with electrocautery scalpels. The plant-based tissue also showed the fluorescent ICG dye, as well as other models or test subjects, would.
"VTT models with ICG-containing tumors could be a very useful tool for teaching surgeons how to remove the tumor by using electrocautery as 'off-the-job' training," Dr. Nishio said.
This study highlights KOTOBUKI Medical's plant-based VTT models as efficient surgical simulators that create no waste and are easy to obtain. It also quantifies the effectiveness of NIR fluorescence-guided surgery as a promising method for tumor removal.
About KOTOBUKI MedicalKOTOBUKI Medical is a medical manufacturing company poised to introduce high-fidelity surgical simulation technology to the world. Founded in 2018, KOTOBUKI Medical aims to introduce eco-friendly and cost-effective alternatives to using animal and even human cadavers for surgical training.
KOTOBUKI Medical uses patented plant-based synthetic tissue to simulate different parts of the human body. The company's Laparo Training Binder won the Good Design Award in 2018. KOTOBUKI Medical has collaborated with Jichi Medical University and the National Cancer Center Hospital East. Learn more about us at https://kotobukimedical.com/en/, or follow us on Twitter and TikTok.
For more information, please email Erin Himeno at 341897@email4pr.com or (+81) 048-951-5211.
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SOURCE KOTOBUKI Medical, Inc.
COMTEX_411499420/2454/2022-08-03T08:46:32
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A total of 897 patients were randomly assigned to a study group: 431 to the chlorhexidine–alcohol group and 466 to the povidone–iodine group (Figure 1). Of the 849 patients who qualified for the intention-to-treat analysis, 409 received chlorhexidine–alcohol and 440 received povidone–iodine. Thirty-six patients were excluded from the per-protocol analysis: 25 underwent clean rather than clean-contaminated surgery, 4 dropped out of the study 1 or 2 days after surgery, and 7 died before completion of the 30-day follow-up (4 in the chlorhexidine–alcohol group and 3 in the povidone–iodine group). Therefore, 813 patients (391 in the chlorhexidine–alcohol group and 422 in the povidone–iodine group) were included in the per-protocol analyses. The patients in the two study groups were similar with respect to demographic characteristics, coexisting illnesses, risk factors for infection, antimicrobial exposure, and duration and types of surgery (Table 1, and Table 1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). All patients received systemic prophylactic antibiotics within 1 hour before the initial incision, and there were no significant differences in the type or number of antibiotics given to the two study groups, even when only patients who underwent colorectal surgery were considered (Table 2 in the Supplementary Appendix).
For the patients in the intention-to-treat population, the overall rate of surgical-site infection was significantly lower in the chlorhexidine–alcohol group (9.5%) than in the povidone–iodine group (16.1%, P=0.004) (Table 2). The relative risk of any surgical-site infection among patients whose skin was preoperatively cleansed with chlorhexidine–alcohol versus povidone–iodine was 0.59 (95% confidence interval [CI], 0.41 to 0.85). Similarly, chlorhexidine–alcohol was associated with significantly fewer superficial incisional infections (relative risk, 0.48; 95% CI, 0.28 to 0.84) and deep incisional infections (relative risk, 0.33; 95% CI, 0.11 to 1.01). However, there were no significant differences between the two study groups in the incidence of organ-space infection (relative risk, 0.97; 95% CI, 0.52 to 1.80) or sepsis from surgical-site infection (relative risk, 0.62; 95% CI, 0.30 to 1.29).
Figure 2.Patients who received chlorhexidine–alcohol were significantly more likely to remain free from surgical-site infection than were those who received povidone–iodine (P=0.004 by the log-rank test). In the chlorhexidine–alcohol group, 39 patients had events (9.5%) and data from 370 patients (90.5%) were censored; in the povidone–iodine group, 71 patients had events (16.1%) and data from 369 patients (83.9%) were censored.
The per-protocol analysis yielded similar efficacy results. The Kaplan–Meier estimates of the risk of surgical-site infection (Figure 2) showed a significantly longer time to infection after surgery in the chlorhexidine–alcohol group than in the povidone–iodine group (P=0.004 by the log-rank test).
Table 3.The interaction between treatment group and type of surgery (abdominal vs. nonabdominal) was included in a logistic-regression model with the main effects of group and surgery type and was found not to be significant (P=0.41). When considered separately in a subgroup analysis (Table 3), the rate of infection after abdominal surgery was 12.5% in the chlorhexidine–alcohol group versus 20.5% in the povidone–iodine group (95% CI for the absolute difference [chlorhexidine–alcohol minus povidone–iodine], −13.9 to −2.1 percentage points). For patients undergoing nonabdominal surgery, the rate of infection was 1.8% in the chlorhexidine–alcohol group versus 6.1% in the povidone–iodine group (95% CI for the absolute difference, −7.9 to 2.6 percentage points).
Both the intention-to-treat analysis (Table 3) and the per-protocol analysis showed lower rates of surgical-site infection in the chlorhexidine–alcohol group than in the povidone–iodine group for each of the seven types of operations studied. Although the trial was not powered to compare the rates of infection for subcategories of patients, infection occurred significantly less often in the chlorhexidine–alcohol group than in the povidone–iodine group in the intention-to-treat analysis for patients who underwent small intestinal surgery (P=0.04) or abdominal surgery (P=0.009) or who did not shower preoperatively (P=0.02).
The Breslow–Day tests indicated homogeneity in showing no significant differences between hospitals with respect to the incidence of either any type of surgical-site infection (P=0.35) or individual types of infection (P≥0.19). Even so, we accounted for hospital site in all logistic-regression models by including this term as a random effect through the use of GEE.
The multivariate logistic-regression analysis identified the following risk factors for surgical-site infection in the intention-to-treat population: use of povidone–iodine, abdominal surgery, alcohol abuse, liver cirrhosis, cancer, diabetes mellitus, malnutrition, gastrointestinal disease, longer duration of surgery, longer duration of placement of surgical drain, and preoperative shower with povidone–iodine (Table 3 in the Supplementary Appendix). Since an analysis of risk factors other than the assigned intervention constitutes an exploratory analysis, which involves multiple simultaneous statistical tests, it could inflate the probability of a false positive finding (type II error).
Culture of the surgical site in 60 of 61 infected patients yielded growth of organisms (a total of 107 isolates), and similar proportions of infected patients in the two study groups (23 of 39 [59%] in the chlorhexidine–alcohol group and 37 of 71 [52%] in the povidone–iodine group) had an identifiable microbiologic cause of infection (Table 4 in the Supplementary Appendix). Gram-positive aerobic bacteria (63 isolates) outnumbered gram-negative aerobic bacteria (25 isolates) by a factor of 2.5, and 38% of cultures were polymicrobial. There were no significant differences in the frequency of isolating certain categories of organisms or particular organisms in the chlorhexidine–alcohol group (total of 44 isolates) as compared with the povidone–iodine group (total of 63 isolates), with the exception of streptococci, which were less common in the former group (1 of 44 [2.3%] vs. 10 of 63 [15.9%], P=0.03).
In the intention-to-treat analysis, adverse events occurred in equal proportions among the patients in the chlorhexidine–alcohol group and the povidone–iodine group (228 of 409 [55.7%] and 256 of 440 [58.2%], respectively), as did serious adverse events (72 of 409 [17.6%] and 70 of 440 [15.9%], respectively) (Table 4, and Table 5 in the Supplementary Appendix). Findings were similar in the per-protocol analysis. Three patients (0.7%) in each study group had an adverse event (pruritus, erythema, or both around the surgical wound) that was judged to be related to the study drugs; however, no serious adverse events were judged to be related to the study drugs. There were no cases of fire or chemical skin burn in the operating room. A total of seven patients died: four (1.0%) in the chlorhexidine–alcohol group who did not have surgical-site infections and three (0.7%) in the povidone–iodine group who died from sepsis due to organ-space infection.
With pandemic-related recommendations and regulations continually evolving along with the coronavirus itself, masks will likely remain a part of people’s lives for some time. Nearly two years into the pandemic, the CDC updated its guidance to clarify that medical-style masks, such as N95s, KN95s, and surgical-style masks, are more protective than cloth ones. Fortunately, these disposable masks, made with nonwoven materials, are now much easier to find compared with early on in the pandemic. Assuming the mask fits well and its filtration has been rigorously tested, these masks are some of the most protective face coverings you can buy.
Still, separating the good options from the bad can be tough. We’ve tried 39 models and confirmed the filtration claims of our favorites with government agencies or our own lab testing performed in collaboration with Colorado State University. Here we recommend legitimate N95, KN95, and surgical masks you can buy from trusted retailers now.
For reusable options, consider the picks in our guide to the best cloth masks for adults. For advice on the best disposable and cloth face masks for children, see our buying guide to kids face masks. To know what masks to avoid, see our blog post on the signs that suggest you have a fake N95, KN95, or KF94.
This odd-looking, oddly comfortable N95 is a NIOSH-approved respirator meant for nonmedical use. Its headbands are soft yet help form a tight seal, and its long nose-bridge wire reduces glasses fogging.
*At the time of publishing, the price was $42.
Despite its weird duckbill shape, the Kimberly-Clark N95 Pouch Respirator is the real deal. Its malleable material and soft headbands form a good seal for most faces, and this mask’s generous cut allows more air to filter in for easier breathing.
The WellBefore WB-N-200 N95 Respirator Mask feels more heavy duty than the typical disposable bifold respirator. Its adjustable headbands help prevent gaps, but they aren’t so snug as to be uncomfortable. Plus, this respirator tents high and wide off the face, so there’s more room to breathe. However, it usually costs more than twice as much as our other respirator picks.
This easy-on, easy-off KN95 respirator mask has ear loops that stretch well for a wider fit but also knot easily for a snugger one.
*At the time of publishing, the price was $10.
If you prefer headbands to ear loops, you may find that this ear-friendly respirator mask provides a better fit.
*At the time of publishing, the price was $12.
The Powecom KN95 design comes in both ear-loop and headband versions, so you have a greater chance of finding something that feels right. Its rounded (instead of flat) fasteners are easier than most to knot, should you need to adjust the fit. Both versions come in black, while the ear-loop masks also come in gray, pink, dark blue, light blue, and red.
Also great for layering, this featherweight surgical mask features notably soft ear loops and foldable edges. It’s costlier than most disposable pleated masks but frequently goes on sale.
*At the time of publishing, the price was $30.
The strikingly soft ear loops on the DemeTech DemeMask Surgical Mask are gentle on the ears. The mask is also FDA-cleared, meeting ASTM Level 3 standards, which means it blocks 98% of particles as small as 0.1 micron in diameter (when worn with a good seal; you may need to knot the ear loops and pleat the mask to achieve this). Besides the typical box of 50, the masks are available in small batches of 10, in both regular and small sizes, and with ties instead of loops.
Surgical masks with proof of high-filtration efficiency typically don’t cost less than $10 for a box of 50 (before tax and shipping), so we were elated to find this box of Medline ASTM Level 1 masks, which are capable of blocking at least 95% of 0.1-micron particles (when worn with a good seal). The ear loops are slightly wider than most we’ve seen, so they easily fit on larger faces or knot and fold (video) for a more secure fit on smaller faces.