Complex physical therapy employing self-adjusting garment (ReadyWrap®) in breast cancer-related lymphedema cases in Brazilian women: a protocol for a randomized controlled trial.

BACKGROUND: Lymphedema is a common complication following breast cancer treatment. The aim of this study is to evaluate the effectiveness of a self-adjusting compression garment (ReadyWrap®) in reducing (phase 1) and maintaining (phase 2) upper limb volume in women presenting breast cancer-related lymphedema. METHODS: This study will comprise a randomized, controlled, single-blind clinical trial concerning women with breast cancer-related lymphedema undergoing treatment at a public cancer treatment reference hospital in the city of Rio de Janeiro, Brazil. The intervention will be carried out by adapting self-dressing versus the standard treatment of compressive bandaging (phase 1) and compressive mesh (phase 2). Both groups will be assessed at the beginning and end of intensive treatment and followed up for up to 12 months to evaluate immediate and late outcomes. Assessments will be carried out by physical upper limb examination (inspection, palpation, volume, dynamometry, and thermography) and questionnaires application to assess patient's quality of life pertaining to the health, functionality, and symptoms of the affected upper limb, as well adverse effects and adherence to treatment. Data will be analyzed descriptively and analytically through univariate and multiple linear regressions. P values < 0.05 will be considered statistically significant. DISCUSSION: This study will evaluate the effectiveness of a self-adjustable garment (ReadyWrap®) in the treatment of lymphedema secondary to breast cancer in Brazilian women compared to the gold standard treatment for limb volume reduction (phase 1) and maintenance (phase 2) phases comprising, respectively, a compressive bandaging and a compressive mesh. The outcome results will provide data based on both quantitative responses and self-reported participant outcomes. The study will also assess the cost-effectiveness of the ReadyWrap® treatment versus standard care. Finally, we expect to reaffirm one more product/therapy as a treatment for this extremely complex and impactful condition following the data analysis. TRIAL REGISTRATION: NCT04934098 [Clinical trials phase 1]. Registered on June 22, 2021. NCT04881604 [Clinical trials phase 2]. Registered on May 11, 2021.

Efficacy and safety of neuromuscular electrical stimulation in the prevention of pressure injuries in critically ill patients: a randomized controlled trial.

BACKGROUND: Pressure injuries (PIs), especially in the sacral region are frequent, costly, and increase morbidity and mortality of patients in an intensive care unit (ICU). These injuries can occur as a result of prolonged pressure and/or shear forces. Neuromuscular electrical stimulation (NMES) can increase muscle mass and improve local circulation, potentially reducing the incidence of PI. METHODS: We performed a randomized controlled trial to assess the efficacy and safety of NMES in preventing PI in critically ill patients. We included patients with a period of less than 48 h in the ICU, aged ≥ 18 years. Participants were randomly selected (1:1 ratio) to receive NMES and usual care (NMES group) or only usual care (control group-CG) until discharge, death, or onset of a PI. To assess the effectiveness of NMES, we calculated the relative risk (RR) and number needed to treat (NNT). We assessed the muscle thickness of the gluteus maximus by ultrasonography. To assess safety, we analyzed the effects of NMES on vital signs and checked for the presence of skin burns in the stimulated areas. Clinical outcomes were assessed by time on mechanical ventilation, ICU mortality rate, and length of stay in the ICU. RESULTS: We enrolled 149 participants, 76 in the NMES group. PIs were present in 26 (35.6%) patients in the CG and 4 (5.3%) in the NMES group (p ˂ 0.001). The NMES group had an RR = 0.15 (95% CI 0.05-0.40) to develop a PI, NNT = 3.3 (95% CI 2.3-5.9). Moreover, the NMES group presented a shorter length of stay in the ICU: Δ = - 1.8 ± 1.2 days, p = 0.04. There was no significant difference in gluteus maximus thickness between groups (CG: Δ = - 0.37 ± 1.2 cm vs. NMES group: Δ = 0 ± 0.98 cm, p = 0.33). NMES did not promote deleterious changes in vital signs and we did not detect skin burns. CONCLUSIONS: NMES is an effective and safe therapy for the prevention of PI in critically ill patients and may reduce length of stay in the ICU. Trial registration RBR-8nt9m4. Registered prospectively on July 20th, 2018, https://ensaiosclinicos.gov.br/rg/RBR-8nt9m4.

The Quality of Mobile Apps Used for the Identification of Pressure Ulcers in Adults: Systematic Survey and Review of Apps in App Stores.

BACKGROUND: The increasing global use of smartphones has contributed to the growing use of apps for various health conditions, showing promising results. Through mobile apps, it is possible to perform chronological and iconographic follow-up of wounds, such as pressure ulcers, using a simple and practical tool. However, numerous surveys have pointed out issues related to the functionality, design, safety, and veracity of app information. OBJECTIVE: The objective of this study was to perform a systematic review of published studies regarding mobile apps and a systematic survey in app stores looking for apps developed to identify, evaluate, treat, and/or prevent pressure ulcers in adults, and to evaluate those apps based on software quality characteristics. METHODS: This review followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The main bibliographic databases were searched between January 1, 2007 and October 15, 2018, and an app survey was performed in app stores. The selected studies were evaluated according to software quality characteristics by the International Organization for Standardization/International Electrotechnical Commission (ie, ISO/IEC 25010:2011) that involve functionality, efficiency, compatibility, usability, reliability, safety, maintenance, and portability. RESULTS: The search in databases and web-based app stores returned a total of 2075 studies. After removal of duplicates and screening of titles and abstracts, 48 complete articles were evaluated for eligibility, and among these, six were included for qualitative synthesis. CONCLUSIONS: In this review, it was observed that all studies involved the initial phase of app development or improvement, and therefore, the apps still need to be evaluated using different software quality characteristics, so that in the future, a gold standard can be approached. Therefore, the prescription of an app for the identification, evaluation, treatment, and/or prevention of pressure ulcers in adults is currently limited. However, the evaluated studies provided important insights for future research. It is of utmost importance that future surveys develop apps jointly with users, using collaborative and cocreative processes and assess patients in real-world situations across different service settings, and they should consider different ethnicities, so that apps are useful to end users, such as patients, family members, health professionals, and students, in the health area. In addition, it is necessary for studies to describe the methodological course of app development in a clear and objective way in order to ensure reproducibility of the study and to offer inputs to allow future research to approach the development of ideal apps that are geared to positively impact the health of end users. TRIAL REGISTRATION: PROSPERO CRD42018114137; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=114137.

Effect of ultrasound and hyaluronidase on gynoid lipodystrophy type II - an ultrasonography study.

INTRODUCTION: The objective of this study was to evaluate the effect of ultrasound and the technique of phonophoresis with hyaluronidase in patients with cellulite edematous type II in the gluteal region. METHODS: Forty-two individuals, all females, were selected and randomly divided into two groups with 21 patients in each. Group I was treated with ultrasound without hyaluronidase and Group II was treated with ultrasound with hyaluronidase. To evaluate individuals, inspection, palpation, photography data and diagnostic ultrasound were performed before and after the treatment. The gluteal region was divided into four areas of 2.5 cm(2); each area received an application of ultrasound. RESULTS: After 10 days of application, both treatments were effective in improving skin appearance and reducing its thickness (epidermis and dermis), as well as that of the hypodermis (p > 0.05). Ultrasound with hyaluronidase induced a larger reduction in skin thickness in the upper medial quadrant and in the lower lateral and medial quadrants, compared to treatment without hyaluronidase. Moreover, there was a significant reduction of the hypodermis in the upper lateral quadrant with hyaluronidase (p > 0.05). CONCLUSION: Both treatments effectively reduced the thickness of skin and the hypodermis; however, the group treated with hyaluronidase-associated ultrasound showed more significant results than that treated with ultrasound only.