A New Therapeutic Approach With Rose Stem-Cell-Derived Exosomes and Non-Thermal Microneedling for the Treatment of Facial Pigmentation.

Background: Facial dyspigmentation is a challenging concern which cannot easily be corrected. Although the application of topical exosomes has shown some efficacy, there is still scarce data addressing the role of plant-derived exosomes for skin hyperpigmentation. Objectives: This study using rose stem-cell-derived exosomes (RSCE) was performed as a proof-of-concept case series to evaluate the efficacy and safety of microneedling and topical RSCE, for the reduction of pigmentation and photoaging in adult volunteers. Methods: Twelve female volunteers were recruited, with a mean age of 46.64 years and a moderate-to-severe facial pigmentation, due to solar lentigines, melasma, postinflammatory hyperpigmentation, and periorbital hyperpigmentation. Three treatments were performed at 3 weeks intervals. These consisted of the topical application of RSCE with microneedling and a 20 min LED light with an RSCE-infused mask. A 3D facial analyzer was used to quantify improvement in superficial, deep pigmentation, skin redness, and wrinkles at baseline, Weeks 3, 6, and 12. Global Aesthetic Improvement Scale (GAIS), Dermatology Life and Quality Index (DLQI), and Melasma Quality of Life Scale (MELASQoL) scores were noted at the same time points. Results: GAIS scores improved by at least 1 scale point. Superficial pigmentation and spots decreased by 12.95% and deep pigmentation improved by 15.9%, by Week 12. Skin redness was reduced by 7.34% at the same time point. The measured wrinkle reduction was 6.34%. DLQI scores were reduced by 10 points, and MELASQoL scores had a mean reduction of 30 points at Week 12. Conclusions: Improvement of facial pigmentation is possible when combining nonthermal microneedling and the use of topical RSCE.

The Superior Effect of Radiofrequency With Targeted Ultrasound for Facial Rejuvenation by Inducing Hyaluronic Acid Synthesis: A Pilot Preclinical Study.

Background: The level of dermal hyaluronic acid (HA) can be depleted by 75% at age 70. HA provides dermal hydration, volume, and thickness, making it a major component of the extracellular matrix. Restoration of dermal and epidermal HA can be achieved by combining radiofrequency (RF) energy and targeted ultrasound (TUS). The monopolar RF generates heat, with the TUS stimulating HA production. The heat induces a regenerative response in the skin, increasing the fibroblast activity and producing various extracellular matrix compounds, including HA. Objectives: To investigate the effect of the simultaneous application of RF + TUS or RF + US on the stimulation of HA production. Methods: Twelve animals underwent 4 treatments. Six were treated with transcutaneous RF + TUS and 6 with the combination RF + US. The opposite untreated side served as a control. Punch biopsies of the skin were taken at baseline, immediately posttreatment, 1 month, and 2 months posttreatment. The tissue was evaluated with real-time quantitative polymerase chain reaction (RT-qPCR), matrix-assisted laser desorption (MALDI) and time of flight (TOF), and confocal microscopy. Results: The RT-qPCR focused on assessing the production of has1 and has2, enzymes responsible for HA synthesis. RT-qPCR results of the RF + TUS group revealed a +98% and +45% increase in hyaluronic synthetase (HAS) 1 and HAS2 production after the treatments, respectively. The MALDI-TOF revealed a +224% increase in measured HA 2 months after the treatments. The changes were also visible in the confocal microscopy. The control group showed no significant (P > .05) results in either of the evaluation methods. Conclusions: Concurrent application of RF and TUS significantly enhances the natural regenerative processes in skin tissue.

Developing the intersectionality supplemented Consolidated Framework for Implementation Research (CFIR) and tools for intersectionality considerations.

BACKGROUND: The concept of intersectionality proposes that demographic and social constructs intersect with larger social structures of oppression and privilege to shape experiences. While intersectionality is a widely accepted concept in feminist and gender studies, there has been little attempt to use this lens in implementation science. We aimed to supplement the Consolidated Framework for Implementation Research (CFIR), a commonly used framework in implementation science, to support the incorporation of intersectionality in implementation science projects by (1) integrating an intersectional lens to the CFIR; and (2) developing a tool for researchers to be used alongside the updated framework. METHODS: Using a nominal group technique, an interdisciplinary framework committee (n = 17) prioritized the CFIR as one of three implementation science models, theories, and frameworks to supplement with intersectionality considerations; the modification of the other two frameworks are described in other papers. The CFIR subgroup (n = 7) reviewed the five domains and 26 constructs in the CFIR and prioritized domains and constructs for supplementation with intersectional considerations. The subgroup then iteratively developed recommendations and prompts for incorporating an intersectional approach within the prioritized domains and constructs. We developed recommendations and prompts to help researchers consider how personal identities and power structures may affect the facilitators and inhibitors of behavior change and the implementation of subsequent interventions. RESULTS: We achieved consensus on how to apply an intersectional lens to CFIR after six rounds of meetings. The final intersectionality supplemented CFIR includes the five original domains, and 28 constructs; the outer systems and structures and the outer cultures constructs were added to the outer setting domain. Intersectionality prompts were added to 13 of the 28 constructs. CONCLUSION: Through an expert-consensus approach, we modified the CFIR to include intersectionality considerations and developed a tool with prompts to help implementation users apply an intersectional lens using the updated framework.

Repurposing the Ordering of Routine Laboratory Tests in Hospitalised Medical Patients (RePORT): results of a cluster randomised stepped-wedge quality improvement study.

BACKGROUND: Low-value use of laboratory tests is a global challenge. Our objective was to evaluate an intervention bundle to reduce repetitive use of routine laboratory testing in hospitalised patients. METHODS: We used a stepped-wedge design to implement an intervention bundle across eight medical units. Our intervention included educational tools and social comparison reports followed by peer-facilitated report discussion sessions. The study spanned October 2020-June 2021, divided into control, feasibility testing, intervention and a follow-up period. The primary outcomes were the number and costs of routine laboratory tests ordered per patient-day. We used generalised linear mixed models, and analyses were by intention to treat. RESULTS: We included a total of 125 854 patient-days. Patient groups were similar in age, sex, Charlson Comorbidity Index and length of stay during the control, intervention and follow-up periods. From the control to the follow-up period, there was a 14% (incidence rate ratio (IRR)=0.86, 95% CI 0.79 to 0.92) overall reduction in ordering of routine tests with the intervention, along with a 14% (ß coefficient=-0.14, 95% CI -0.07 to -0.21) reduction in costs of routine testing. This amounted to a total cost savings of $C1.15 per patient-day. There was also a 15% (IRR=0.85, 95% CI 0.79, 0.92) reduction in ordering of all common tests with the intervention and a 20% (IRR=1.20, 95% CI 1.10 to 1.30) increase in routine test-free patient-days. No worsening was noted in patient safety endpoints with the intervention. CONCLUSIONS: A multifaceted intervention bundle using education and facilitated multilevel social comparison was associated with a safe and effective reduction in use of routine daily laboratory testing in hospitals. Further research is needed to understand how system-level interventions may increase this effect and which intervention elements are necessary to sustain results.

The Effect of Hybrosome (Umbilical Cord Blood Exosome-Liposome Hybrid Vesicles) on Human Dermal Cells In Vitro.

Background: Wound healing is a process that involves multiple physiological steps, and despite the availability of various wound treatment methods, their effectiveness is still limited due to several factors, including cost, efficiency, patient-specific requirements, and side effects. In recent years, nanovesicles called exosomes have gained increasing attention as a potential wound care solution due to their unique cargo components which enable cell-to-cell communication and regulate various biological processes. Umbilical cord blood plasma (UCBP) exosomes have shown promise in triggering beneficial signaling pathways that aid in cell proliferation and wound healing. However, there is still very limited information about the wound-healing effect of UCBP exosomes in the literature. Objectives: The primary objective of this study was to investigate the "hybrosome" technology generated with calf UCBP-derived exosome-liposome combination. Methods: The authors developed hybrosome technology by fusing cord blood exosome membranes with liposomes. Nanovesicle characterization, cell proliferation assay, wound-healing scratch assay, immunohistochemistry analysis, anti-inflammation assay, real-time polymerase chain reaction (RT-PCR), enzyme-linked immunosorbent assay, and cellular uptake studies were performed using the novel hybrid exosomes. Results: Experimental results showed that hybrosome increases cell proliferation and migration by 40% to 50%, depending on the dose, and induces an anti-inflammatory effect on different cell lines as well as increased wound healing-related gene expression levels in dermal cells in vitro. All in all, this research widens the scope of wound-healing therapeutics to the novel hybrosome technology. Conclusions: UCBP-based applications have the potential for wound treatments and are promising in the development of novel therapies. This study shows that hybrosomes have outstanding abilities in wound healing using in vitro approaches.

Effectiveness of combined use of targeted pressure energy, radiofrequency, and high-intensity focused electromagnetic fields to improve skin quality and appearance of fat and muscle tissue in different body parts.

BACKGROUND: Inevitable signs of aging are especially noticeable in middle to elder age when stretch marks, loose skin, cellulite, and body-contour changes naturally appear. AIMS: To verify efficacy of high-intensity focused electromagnetic field (HIFEM), radiofrequency (RF), and Targeted Pressure Energy (TPE) combination treatment to address unfavorable changes in skin, fat, and muscle tissue. METHODS: The device simultaneously emitting monopolar RF and TPE energies was consecutively combined with simultaneous HIFEM+RF procedure in 32 subjects (21-64 years, 17.4-33.5 kg/m2 ) for treatment of thighs (N = 15; back, inner, or front), buttocks/saddlebags (N = 7), abdomen (N = 8), and upper arms (N = 2). All patients underwent four weekly, combined treatments of 30-min HIFEM+RF procedure followed by 15-30 min RF+TPE, depending on treatment area. Circumferential measurements, digital photographs, subject satisfaction, and comfort questionnaires were assessed up to 3-months post-treatment. RESULTS: Majority of participants found treatments comfortable, no adverse events occurred. Subjects showed substantial improvement in all treated areas from 1-month follow-up. Combination of HIFEM+RF, monopolar RF, and TPE resulted in significant circumference decrease. Generally, more pronounced results were seen at 3 months when subjects showed -5.2 cm on abdomen, -3.0 cm on thighs, and -5.5 cm on saddlebags, respectively. Ninety-four percent of subjects were satisfied with treatment results, most noticed improvement in cellulite, skin laxity, and muscle definition. CONCLUSIONS: Results showed high patient satisfaction and efficacy in improving body contour and skin quality. Combining simultaneous HIFEM+RF procedure with simultaneous monopolar RF+TPE treatments considerably enhanced body contour and skin tissue. The procedure proved versatile and may effectively treat multiple body parts.

Safety and Efficacy of Simultaneous Application of High-intensity Focused Electromagnetic Field and Synchronized Radiofrequency for Non-invasive Fat Reduction and Muscle Toning in Inner Thighs: Magnetic Resonance Imaging Evaluation.

Background: High-intensity focused electromagnetic field (HIFEM) and radiofrequency (RF) are established stand-alone techniques used in body contouring. However, data on the simultaneous combination and effects of these modalities for inner thigh treatment is lacking. Objective: To investigate the efficacy and safety of the HIFEM+RF procedure for non-invasive fat reduction in the inner thigh, as well as toning and strengthening of the inner thigh muscles. Methods: Sixteen women with an average age of 47.31±12.51 years were recruited. Each patient received four 30-minute bilateral treatments on the inner thighs once a week. Magnetic resonance imaging (MRI) scans of the treated area were evaluated at baseline, one-, and three-month follow-up visits for subcutaneous fat and muscle thickness changes. Anthropometric data and digital photographs were collected. Subject satisfaction and therapy comfort were evaluated. Results: The results peaked at three months, showing significant changes in both treated tissues. On average, the fat thickness was reduced by 27.4 percent (p<0.001), while muscle tissue showed an average increase of 23.2 percent. Thigh circumference was reduced on average by 1.52cm, with a maximum change of -1.8cm, observed at 5cm below the gluteal crease. The treatment was considered comfortable with high patient satisfaction. Conclusion: Analysis of magnetic resonance images and thigh circumference showed that therapy combining HIFEM and RF is highly effective for subcutaneous fat reduction and increased muscle thickness in inner thighs.

Roundtable Discussion: Making Sense of Current Liposuction Technologies.

Suction-assisted lipectomy (or "liposuction") is a fundamental technique for all plastic surgeons, and like many procedures in aesthetic surgery, its applications are continuing to evolve. With the rapid introduction of new technologies, many plastic surgeons are left with questions about how these new devices work, what results to expect, and how to best apply these technologies in their practice. We recognized that there is a need for unbiased recommendations to guide surgeons on how to approach current liposuction devices (as well as their adjuncts) and how to use them effectively for their patients. Using available literature and personal experience, we answer the most common questions that we hear from our plastic surgery colleagues.

Combination treatment for buttock and abdominal remodeling and skin improvement using HIFEM procedure and simultaneous delivery of radiofrequency and targeted pressure energy.

BACKGROUND: High-intensity electromagnetic field procedure (HIFEM) is an effective tool for body shaping and muscle toning. Radiofrequency (RF) combined with targeted pressure energy (TPE) provides the solution for skin laxity and cellulite. AIMS: To document the effect of consecutive use of HIFEM, RF, and TPE for treatment of abdomen and buttocks. METHODS: Fifteen subjects (44.3 ± 14.2 years, 22.3 ± 2.3 kg/m2 ) finished treatments and consequent follow-ups. They were treated over the abdomen (Group 1, N = 7) or buttocks (Group 2, N = 8), receiving four treatment procedures consisting of HIFEM treatment administered first, immediately followed by the simultaneous RF & TPE treatment. Each session took approximately 50 min (30 min of HIFEM; up to 20 min of RF & TPE) depending on the treated area. Study outcomes were assessed by the circumference measurement, satisfaction and comfort questionnaires, and digital photographs. RESULTS: Combined treatments were safe and comfortable. At 1 month, the abdominal circumference significantly decreased by 4.4 cm, while buttocks showed a significant increase by 1.0 cm. The abdomen (-4.1 cm) and buttocks (+1.2 cm) circumference results were sustained for three months without a significant decline. Satisfaction was high in both groups (93.3%) since most subjects noted that the appearance of the treated area has been improved, referring to both body sculpting and skin appearance. CONCLUSIONS: The consecutive application of HIFEM, RF, and TPE treatments noticeably improved the appearance of the abdomen and buttocks. Subjects showed enhancement of abdominal body contour, buttock lifting, and improved skin quality manifested by reduced skin laxity and cellulite.

'Doing' or 'using' intersectionality? Opportunities and challenges in incorporating intersectionality into knowledge translation theory and practice.

Intersectionality is a widely adopted theoretical orientation in the field of women and gender studies. Intersectionality comes from the work of black feminist scholars and activists. Intersectionality argues identities such as gender, race, sexuality, and other markers of difference intersect and reflect large social structures of oppression and privilege, such as sexism, racism, and heteronormativity. The reach of intersectionality now extends to the fields of public health and knowledge translation. Knowledge translation (KT) is a field of study and practice that aims to synthesize and evaluate research into an evidence base and move that evidence into health care practice. There have been increasing calls to bring gender and other social issues into the field of KT. Yet, as scholars outline, there are few guidelines for incorporating the principles of intersectionality into empirical research. An interdisciplinary, team-based, national health research project in Canada aimed to bring an intersectional lens to the field of knowledge translation. This paper reports on key moments and resulting tensions we experienced through the project, which reflect debates in intersectionality: discomfort with social justice, disciplinary divides, and tokenism. We consider how our project advances intersectionality practice and suggests recommendations for using intersectionality in health research contexts. We argue that while we encountered many challenges, our process and the resulting co-created tools can serve as a valuable starting point and example of how intersectionality can transform fields and practices.

Lifting and Toning of Arms and Calves Using High-Intensity Focused Electromagnetic Field (HIFEM) Procedure Documented by Ultrasound Assessment.

OBJECTIVE: The HIFEM procedure demonstrates positive outcomes on abdomen and buttock. This multi-center study aims to investigate its effect on adipose tissue and muscle mass located in upper arms and calves. MATERIALS AND METHODS: Twenty subjects (45.10±15.19 years, 24.44±3.22 kg/m2) who underwent a HIFEM procedure (4 sessions; 20 minutes per muscle group) on arms and calves were evaluated. Overall, 7 patients were treated over biceps and triceps, 4 patients over calves, and 9 patients underwent treatment of both upper arms and calves. The changes in adipose and muscle tissue of musculus biceps brachii, triceps brachii, and gastrocnemius were evaluated by using ultrasound. The results from a 1-month, 3-month, and 6-month follow-up were compared to the baseline. Digital photographs, weight measurements, satisfaction, and comfort questionnaires were assessed at baseline and follow-ups. RESULTS: Ultrasound images revealed a significant (P<0.05) increase in the muscle mass of all studied muscles, with the most noticeable improvement in biceps brachii (+16.13% at 3 months). The fat deposits over arms and calves showed significant improvement (P<0.05), reaching -15.12% at 3 months. The results peaked at 3 months and were sustained up to 6 months with a slight but insignificant decline. Aesthetic enhancement of treated areas was documented while patients were highly satisfied. CONCLUSIONS: The achieved outcomes showed that the HIFEM procedure is effective for muscle toning and fat reduction in arms and calves. The results suggest that the use of the HIFEM procedure is not limited only to abdominal and buttock shaping but is also effective for toning of arms and calves. J Drugs Dermatol. 2021;20(7):755-759. doi:10.36849/JDD.5878.

Activation of Skeletal Muscle Satellite Cells by a Device Simultaneously Applying High-Intensity Focused Electromagnetic Technology and Novel RF Technology: Fluorescent Microscopy Facilitated Detection of NCAM/CD56.

BACKGROUND: Myosatellite cells are myogenic stem cells that can transform to provide nuclei for existing muscles or generate new muscle fibers as documented after extended exercise programs. OBJECTIVES: The authors investigated whether the simultaneous application of High-Intensity Focused Electromagnetic (HIFEM) and Synchrode radiofrequency (RF) affects the levels of satellite cells similarly as the prolonged exercise does to achieve muscle growth. METHODS: Three 30-minute simultaneous HIFEM and Synchrode RF treatments (once a week) were administered over the abdominal area of 5 Large White swine aged approximately 6 months. All animals were anesthetized during the treatments and biopsy acquisition. Biopsies of muscle tissue were collected at baseline, 4 days, 2 weeks, and 1 month post-treatment. After binding the specific antibodies, the NCAM/CD56 levels, a marker of activated satellite cells, were quantified employing the immunofluorescence microscopy technique with a UV lamp. RESULTS: Examined slices showed a continuous increase in satellite cell levels throughout the study. Four days after the treatment, we observed a 26.1% increase in satellite cells, which increased to 30.2% at 2-week follow-up. Additional histological analysis revealed an increase in the cross-sectional area of muscle fibers and the signs of newly formed fibers of small diameters at 2 weeks after the treatment. No damage to muscle tissue and no adverse effects related to the treatment were observed. CONCLUSIONS: The findings indicate that the simultaneous application of HIFEM and novel Synchrode RF treatment can initiate differentiation of satellite cells to support the growth of existing muscles and, presumably, even the formation of new myofibers.

The Aging neck-A Case base treatment algorithm.

BACKGROUND: Effective nonsurgical treatments for the aging face are widely accepted and utilized. Although changes in the aging neck, often patients to seek esthetic rejuvenation protocols are neither well defined nor well designed. Increasingly, patients desire less invasive cosmetic treatments with less morbidity and downtime. A significant challenge exists in managing expectations and educating patients about the pros and cons of a surgical approach compared to the plethora of nonsurgical options. When equipped with state of the art information and technique, using a multi-modality nonsurgical approach, surprisingly outstanding results may be obtained. AIMS: In this paper, we aim to revisit the neck's anatomy and then demonstrate current nonsurgical techniques in managing actual cases. METHODS: To achieve that, we have utilized an intuitive four-point grading scale to guide both physician and patient regarding appropriate treatment combinations. RESULTS: The proposed four-point scale was applied to six patients and their treatment plan was described in detail. CONCLUSIONS: Skin laxity is not the only factor that comes into play when assessing the neck. careful analysis of the neck and face hold the key for treatment choice and execution.

Noninvasive Induction of Muscle Fiber Hypertrophy and Hyperplasia: Effects of High-Intensity Focused Electromagnetic Field Evaluated in an In-Vivo Porcine Model: A Pilot Study.

BACKGROUND: High-intensity focused electromagnetic (HIFEM) field technology has been reported to increase muscle thickness and hypertrophy. However, this process has not yet been confirmed on a histologic level. OBJECTIVES: The aim of this study was to evaluate in-vivo structural changes in striated porcine muscle tissue following HIFEM treatment. METHODS: Three Yorkshire pigs received four 30-minute HIFEM treatments applied to the biceps femoris muscle on 1 side only. The fourth pig served as a control subject. At baseline and 2 weeks after the last treatment, biopsy specimens of the muscle tissue were collected from the treatment site. The control pig underwent muscle biopsy from a similar but untreated site. Twenty-five histology slides were evaluated from each pig. A certified histopathologist analyzed sliced biopsy samples for structural changes in the tissue. RESULTS: Histologic analysis showed hypertrophic changes 2 weeks posttreatment. The muscle mass density increased by 20.56% (to a mean of 17,053.4 [5617.9] µm2) compared with baseline. Similarly, muscle fiber density (hyperplasia) increased: the average change in the number of fibers in a slice area of 136,533.3 µm2 was +8.0%. The mean size of an individual muscle fiber increased by 12.15% (to 332.23 [280.2] µm2) 2 weeks posttreatment. Control samples did not show any significant change in fiber density or hyperplasia. CONCLUSIONS: Histopathologic quantification showed significant structural muscle changes through a combination of fiber hypertrophy and hyperplasia. Control biopsies showed a lack of similar changes. The data correlate with findings of other HIFEM research and suggest that HIFEM could be used for noninvasive induction of muscle growth.

The Calgary Audit and Feedback Framework: a practical, evidence-informed approach for the design and implementation of socially constructed learning interventions using audit and group feedback.

BACKGROUND: Audit and feedback interventions may be strengthened using social interaction. The Calgary office of the Alberta Physician Learning Program (CPLP) developed a process for audit and group feedback for physicians. This paper extends previous work in which we developed a conceptual model of physician responses to audit and group feedback based on a qualitative analysis of six audit and group feedback sessions. The present study explored the mediating factors for successfully engaging physician groups in change planning through audit and group feedback. METHODS: To understand why some groups were more interactive than others, we completed a comparative case analysis of the six audit and group feedback projects from the prior study. We used framework analysis to build the case studies, triangulated our observations across data sources to validate findings, compared the case studies for similarities and differences that influenced social interaction (mediating factors), and thematically categorized mediating factors into an organizing framework. RESULTS: Mediating factors for socially interactive AGFS were a pre-existing relationship between the program team and the physician group, projects addressing important, actionable questions, easily interpretable data visualization in the reports, and facilitation of the groups that included reflective questioning. When these factors were in place (cases 1, 2A, 3), the audit and group feedback sessions were dynamic, with physicians sharing and comparing practices, and raising change cues (such as declaring commitments to de-prescribing, planning educational interventions, and improving documentation). In cases 2C-D, the mediating factors were less well established and in these cases, the sessions showed little physician reflection or change planning. We organized the mediating factors into a framework linking the factors for successful sessions to the conceptual model of physician behaviors which these mediating factors drive. CONCLUSIONS: We propose the Calgary Audit and Feedback Framework as a practical tool to help foster socially constructed learning in audit and group feedback sessions. Ensuring that the four factors, relationship, question choice, data visualization, and facilitation, are considered for design and implementation of audit and group feedback will help physicians move from reactions to their data towards planning for change.

Microneedling with Biologicals: Advantages and Limitations.

Microneedling is a popular and cost-effective treatment with little down time. The application of topical agents to enhance outcomes is common practice. Microchannels created with nonthermal needling close at 4 hours to 6 hours due to fibrin plugs. Channels created with thermal needling or fractional laser stay open longer and enhance drug or biological uptake more due to the dermal sponge injury pattern that is created. Nonthermal microneedling devices may need Food and Drug Administration clearance, which also notes that dermaceuticals should be considered drugs in many cases.