Optimizing Tissue Oxygenation in Reduction Mammoplasty: The Role of Continuous Diffusion of Oxygen: A Feasibility Pilot Randomized Controlled Trial.

INTRODUCTION: Bilateral reduction mammoplasty (BRM) aims to alleviate macromastia-related symptoms in women. This procedure involves a T-Junction suture at the medial inframammary fold that encompasses 12%-39% of wound breakdowns mainly due to reduced perfusion. Continuous diffusion of oxygen (CDO) may enhance breast tissue oxygenation to prevent such complication. We explored the feasibility of this therapy. METHODS: A 4-wk feasibility-pilot randomized controlled trial of women undergoing BRM was conducted. By internal randomization (left/right side), participants received standard of care (SOC) in one breast using topical skin adhesive, while their other breast received SOC + CDO at the T-junction covered by a silicon sheet (sCDO), or CDO directly to the T-Junction skin (dCDO). Feasibility outcomes included protocol delivery, outcome measurement, device-related adverse events, and device acceptability. Exploratory outcomes were T-Junction SatO2 and deoxyhemoglobin assessed with near-infrared spectroscopy and wound dehiscence. RESULTS: Sixteen participants (age = 33 ± 8 y; body mass index = 34.34 ± 5.85 kg/m2) were recruited, conforming n = 32 breasts (SOC, n = 16; dCDO, n = 10, sCDO, n = 6). At 4 wk, protocol delivery was 93.7%, outcome measuring 100%, and device-related adverse events 0%. Device acceptability showed an 85.4% strong agreement for attitude toward use, 78.2% perceived ease of use, and 77.7% perceived usefulness. Breasts undergoing sCDO showed higher SatO2 (P < 0.001), whereas lower deoxyhemoglobin (P < 0.001) compared to all other breast groups. However, wound dehiscence was not different between groups (P = 0.66). CONCLUSIONS: Self-applied CDO to the T-Junction is feasible, safe, and acceptable, in patients undergoing BRM. In a proper wound environment, CDO may enhance breast tissue oxygenation. However, it is unclear whether CDO leads to decreased wound dehiscence. This study showed reproducibility for larger randomized trials.

Frailty in People with Chronic Limb Threatening Ischemia and Diabetes-Related Foot Ulcers: A Systematic Review.

BACKGROUND: Frailty represents a state of multisystem impairment that may adversely impact people presenting with chronic limb-threatening ischemia (CLTI) and diabetes-related foot ulcers (DFUs). The aim of this systematic review was to explore the association between frailty and outcomes from CLTI and DFUs. METHODS: We performed a systematic literature search of electronic databases to find studies using a validated measure of frailty in individuals with CLTI and/or DFUs. The primary outcomes were the impact of frailty on the severity of initial clinical presentation and unfavorable follow-up outcomes including readmissions, major limb amputation, cardiovascular events, revascularization, and wound healing. RESULTS: Ten cohort studies were included. Two studies had a low risk of bias, 1 was unable to be assessed, 5 had moderate risk of bias, and 2 high risk of bias. The prevalence of frailty in people presenting with CLTI ranged from 27% to 88% and was 71% in people with DFUs. The presence of frailty in both people with CLTI and DFUs was associated with substantially increased severity at presentation (severity of ischemia and tissue loss) and poorer outcomes at follow-up (risk of readmission, limb amputation, and all-cause mortality). CONCLUSIONS: The presence of frailty in both people with CLTI and DFUs is likely associated with substantially higher complexity at presentation followed by a greater risk for readmission, amputation, and death during follow-up. Heterogeneity in the tools used to screen for frailty, poor definition of frailty, and unclear evaluation of exposure and outcomes limit further interpretation of findings.

Continuous Diffusion of Oxygen Adjunct Therapy to Improve Scar Reduction After Cervicotomy - A Proof of Concept Randomized Controlled Trial.

BACKGROUND: Dressing materials are known to influence post-operative surgical wound healing and scar formation (SF). A particular dressing that could promote wound hydration is essential to ensure quick epithelialization and reduce SF. This study examined the effectiveness of a novel Continuous Diffusion of Oxygen (CDO) dressing to reduce scar length post cervicotomy. METHODS: A randomized controlled trial was performed in patients undergoing cervicotomy, either for thyroid or parathyroid disease. Patients were randomized to either control (CG) or intervention (IG) groups. The IG received a portable CDO system (TransCu O2, EO2 Concepts Inc., TX, USA), whereas the CG received a standard dressing for a 4-week period. The primary outcome was >10% of scar length reduction and %change in scar length. RESULTS: 21 patients were recruited (Age: 53 ± 16 years; 90% female; CG = 9, IG = 12). 5 patients were lost to follow-up. At 4 weeks, 88.8% of the IG significantly achieved >10% of scar reduction (versus CG = 28.5%, d = 0.48, P = 0.049), showing a 40.4% smaller scar (15.7% versus 11.2%, d = 0.13, P = 0.72) compared to the CG. However, the difference was not significant. A sub-sample of patients undergoing thyroidectomy showed a significant scar reduction using CDO (IG = 11.6% versus CG = 5.1%, d = 2.96, P = 0.009). CONCLUSIONS: This is the first study to assess scar reduction using CDO adjunct therapy after cervicotomy. Advanced CDO dressings may assist wound healing showing improved outcomes for scar visualization in patients undergoing thyroidectomy. A larger sample is required to validate this observation.

Digital Biomarkers of Physical Frailty and Frailty Phenotypes Using Sensor-Based Physical Activity and Machine Learning.

Remote monitoring of physical frailty is important to personalize care for slowing down the frailty process and/or for the healthy recovery of older adults following acute or chronic stressors. Taking the Fried frailty criteria as a reference to determine physical frailty and frailty phenotypes (slowness, weakness, exhaustion, inactivity), this study aimed to explore the benefit of machine learning to determine the least number of digital biomarkers of physical frailty measurable from a pendant sensor during activities of daily living. Two hundred and fifty-nine older adults were classified into robust or pre-frail/frail groups based on the physical frailty assessments by the Fried frailty criteria. All participants wore a pendant sensor at the sternum level for 48 h. Of seventeen sensor-derived features extracted from a pendant sensor, fourteen significant features were used for machine learning based on logistic regression modeling and a recursive feature elimination technique incorporating bootstrapping. The combination of percentage time standing, percentage time walking, walking cadence, and longest walking bout were identified as optimal digital biomarkers of physical frailty and frailty phenotypes. These findings suggest that a combination of sensor-measured exhaustion, inactivity, and speed have potential to screen and monitor people for physical frailty and frailty phenotypes.

Digital Biomarker Representing Frailty Phenotypes: The Use of Machine Learning and Sensor-Based Sit-to-Stand Test.

Since conventional screening tools for assessing frailty phenotypes are resource intensive and unsuitable for routine application, efforts are underway to simplify and shorten the frailty screening protocol by using sensor-based technologies. This study explores whether machine learning combined with frailty modeling could determine the least sensor-derived features required to identify physical frailty and three key frailty phenotypes (slowness, weakness, and exhaustion). Older participants (n = 102, age = 76.54 ± 7.72 years) were fitted with five wearable sensors and completed a five times sit-to-stand test. Seventeen sensor-derived features were extracted and used for optimal feature selection based on a machine learning technique combined with frailty modeling. Mean of hip angular velocity range (indicator of slowness), mean of vertical power range (indicator of weakness), and coefficient of variation of vertical power range (indicator of exhaustion) were selected as the optimal features. A frailty model with the three optimal features had an area under the curve of 85.20%, a sensitivity of 82.70%, and a specificity of 71.09%. This study suggests that the three sensor-derived features could be used as digital biomarkers of physical frailty and phenotypes of slowness, weakness, and exhaustion. Our findings could facilitate future design of low-cost sensor-based technologies for remote physical frailty assessments via telemedicine.

Decrease in Mobility during the COVID-19 Pandemic and Its Association with Increase in Depression among Older Adults: A Longitudinal Remote Mobility Monitoring Using a Wearable Sensor.

BACKGROUND: Social isolation during COVID-19 may negatively impact older adults' wellbeing. To assess its impact, we measured changes in physical activity and sleep among community-dwelling older adults, from pre-to post-pandemic declaration. METHOD: Physical activity and sleep in older adults (n = 10, age = 77.3 ± 1.9 years, female = 40%) were remotely assessed within 3-month pre-to 6-month post-pandemic declaration using a pendant-wearable system. Depression was assessed pre-and post-pandemic declaration using the Center for Epidemiologic Studies Depression scale and was compared with 48 h continuous physical activity monitoring data before and during pandemic. RESULTS: Compared to pre-pandemic, post-pandemic time spent in standing declined by 32.7% (Cohen's d = 0.78, p < 0.01), walking by 52.2% (d = 1.1, p < 0.01), step-counts by 55.1% (d = 1.0, p = 0.016), and postural transitions by 44.6% (d = 0.82, p = 0.017) with increase in sitting duration by 20.5% (d = 0.5, p = 0.049). Depression symptoms increased by 150% (d = 0.8, p = 0.046). Interestingly, increase in depression was significantly correlated with unbroken-prolong sitting bout (ρ = 0.677, p = 0.032), cadence (ρ = -0.70, p = 0.024), and sleep duration (ρ = -0.72, p = 0.019). CONCLUSION: This is one of the early longitudinal studies highlighting adverse effect of the pandemic on objectively assessed physical activity and sleep in older adults. Our observations showed need for timely intervention to mitigate hard to reverse consequences of decreased physical activity such as depression.

Harnessing Digital Health Technologies to Remotely Manage Diabetic Foot Syndrome: A Narrative Review.

About 422 million people worldwide have diabetes and approximately one-third of them have a major risk factor for diabetic foot ulcers, including poor sensation in their feet from peripheral neuropathy and/or poor perfusion to their feet from peripheral artery disease. The current healthcare ecosystem, which is centered on the treatment of established foot disease, often fails to adequately control key reversible risk factors to prevent diabetic foot ulcers leading to unacceptable high foot disease amputation rate, 40% recurrence of ulcers rate in the first year, and high hospital admissions. Thus, the latest diabetic foot ulcer guidelines emphasize that a paradigm shift in research priority from siloed hospital treatments to innovative integrated community prevention is now critical to address the high diabetic foot ulcer burden. The widespread uptake and acceptance of wearable and digital health technologies provide a means to timely monitor major risk factors associated with diabetic foot ulcer, empower patients in self-care, and effectively deliver the remote monitoring and multi-disciplinary prevention needed for those at-risk people and address the health care access disadvantage that people living in remote areas. This narrative review paper summarizes some of the latest innovations in three specific areas, including technologies supporting triaging high-risk patients, technologies supporting care in place, and technologies empowering self-care. While many of these technologies are still in infancy, we anticipate that in response to the Coronavirus Disease 2019 pandemic and current unmet needs to decentralize care for people with foot disease, we will see a new wave of innovations in the area of digital health, smart wearables, telehealth technologies, and "hospital-at-home" care delivery model. These technologies will be quickly adopted at scale to improve remote management of diabetic foot ulcers, smartly triaging those who need to be seen in outpatient or inpatient clinics, and supporting acute or subacute care at home.

Smart Offloading Boot System for Remote Patient Monitoring: Toward Adherence Reinforcement and Proper Physical Activity Prescription for Diabetic Foot Ulcer Patients.

BACKGROUND: A critical factor in healing diabetic foot ulcers is patient adherence to offloading devices. We tested a smart offloading boot (SmartBoot) combined with a smartwatch app and cloud dashboard to remotely monitor patient adherence and activity. In addition, the impact of SmartBoot on balance, gait, and user experience was investigated. METHODS: Fourteen volunteers (31.6±8.7 years; 64% female) performed natural activities (eg, sitting, standing, walking) with and without the SmartBoot for approximately 30 minutes. All participants completed balance tests, 10-meter walking tests at slow, normal, and fast pace while wearing the SmartBoot, and a user experience questionnaire. The accuracy of real-time adherence reporting was assessed by comparing the SmartBoot and staff observation. Center of mass (COM) sway and step counts were measured using a validated wearable system. RESULTS: Average sensitivity, specificity, and accuracy for adherence and non-adherence were 90.6%, 88.0%, and 89.3%, respectively. The COM sway area was significantly smaller with the SmartBoot than without the SmartBoot regardless of test condition. Step count error was 4.4% for slow waking, 36.2% for normal walking, 16.0% for fast walking. Most participants agreed that the SmartBoot is easy to use, relatively comfortable, nonintrusive, and innovative. CONCLUSIONS: To our knowledge, this is the first smart offloading system that enables remote patient monitoring and real-time adherence and activity reporting. The SmartBoot enhanced balance performance, likely due to somatosensory feedback. Questionnaire results highlight SmartBoot's technical and clinical potential. Future studies warrant clinical validation of real-time non-adherence alerting to improve wound healing outcomes in people with diabetic foot ulcers.

Association between Fall History and Gait, Balance, Physical Activity, Depression, Fear of Falling, and Motor Capacity: A 6-Month Follow-Up Study.

Maintaining function in older adults is key to the quality of life and longevity. This study examined the potential impact of falls on accelerating further deterioration over time in gait, balance, physical activity, depression, fear of falling, and motor capacity in older adults. 163 ambulatory older adults (age = 76.5 ± 7.7 years) participated and were followed for 6 months. They were classified into fallers or non-fallers based on a history of falling within the past year. At baseline and 6 months, all participants were objectively assessed for gait, balance, and physical activity using wearable sensors. Additional assessments included psychosocial concerns (depression and fear of falling) and motor capacity (Timed Up and Go test). The fallers showed lower gait performance, less physical activity, lower depression level, higher fear of falling, and less motor capacity than non-fallers at baseline and 6-month follow-up. Results also revealed acceleration in physical activity and motor capacity decline compared to non-fallers at a 6-month follow-up. Our findings suggest that falls would accelerate deterioration in both physical activity and motor performance and highlight the need for effective therapy to reduce the consequences of falls in older adults.

Safety and efficacy of electrical stimulation for lower-extremity muscle weakness in intensive care unit 2019 Novel Coronavirus patients: A phase I double-blinded randomized controlled trial.

Background: Intensive care unit (ICU) prolonged immobilization may lead to lower-extremity muscle deconditioning among critically ill patients, particularly more accentuated in those with 2019 Novel Coronavirus (COVID-19) infection. Electrical stimulation (E-Stim) is known to improve musculoskeletal outcomes. This phase I double-blinded randomized controlled trial examined the safety and efficacy of lower-extremity E-Stim to prevent muscle deconditioning. Methods: Critically ill COVID-19 patients admitted to the ICU were randomly assigned to control (CG) or intervention (IG) groups. Both groups received daily E-Stim (1 h) for up to 14 days on both gastrocnemius muscles (GNMs). The device was functional in the IG and non-functional in the CG. Primary outcomes included ankle strength (Ankles) measured by an ankle-dynamometer, and GNM endurance (GNMe) in response to E-Stim assessed with surface electromyography (sEMG). Outcomes were measured at baseline, 3 and 9 days. Results: Thirty-two (IG = 16, CG = 16) lower extremities in 16 patients were independently assessed. The mean time between ICU admission and E-Stim therapy delivery was 1.8 ± 1.9 days (p = 0.29). At 3 days, the IG showed an improvement compared to the CG with medium effect sizes for Ankles (p = 0.06, Cohen's d = 0.77) and GNMe (p = 0.06, d = 0.69). At 9 days, the IG GNMe was significantly higher than the CG (p = 0.04, d = 0.97) with a 6.3% improvement from baseline (p = 0.029). E-Stim did not alter vital signs (i.e., heart/respiratory rate, blood saturation of oxygen), showed no adverse events (i.e., pain, skin damage, discomfort), nor interfere with ICU standard of care procedures (i.e., mechanical ventilation, prone rotation). Conclusion: This study supports the safety and efficacy of early E-Stim therapy to potentially prevent deterioration of lower-extremity muscle conditions in critically ill COVID-19 patients recently admitted to the ICU. If confirmed in a larger sample, E-Stim may be used as a practical adjunctive therapy. Clinical trial registration: [https://clinicaltrials.gov/], identifier [NCT04685213].