Edema

This research aims to evaluate the Dayspring Active Wearable Compression Technology in improving lymph flow and to assess its safety and effectiveness in patients who have undergone lymphatic surgery for breast cancer-related lymphedema BCRL. The study focuses on adults diagnosed with upper extremity edema after lymphatic surgery and investigates how this device may help manage symptoms associated with BCRL. Participants will use the Dayspring Active Wearable Compression System, a device designed to enhance lymph movement following lymphatic surgery. The study is open-label and non-randomized, involving patients with breast cancer-related lymphedema who meet specific volume difference criteria between limbs. The intervention period includes baseline assessments and follow-up evaluations at 28 days. During the study, participants will undergo ICG Fluorescence Lymphatic Imaging both at the start and on day 28 to measure lymphatic function. Researchers will monitor safety and effectiveness through these imaging assessments and track participant adherence to device use. The total participation duration includes initial and follow-up visits within the 28-day study period.

Researchers are evaluating the safety and effectiveness of the Symani Surgical System in microsurgical anastomosis during free tissue transfer and lymphovenous anastomosis surgeries. The study focuses on how well the device maintains vessel connection at the first attempt and monitors any device-related adverse events. Participants include adults with clinical indications for these specific microsurgical procedures. The Symani Surgical System, designed for open microsurgery with articulated and interchangeable instruments, is used during surgeries involving vessels between 0.1 and 2.5 mm in diameter. Participants undergo treatment as part of standard care and may be in either free tissue transfer surgery or lymphovenous anastomosis surgery groups. Those in the lymphovenous anastomosis group complete questionnaires and follow prescribed self-care and compression garment use over the study. Participants provide consent for researchers to access their medical information and agree to attend follow-up visits, completing all study procedures and questionnaires. Researchers measure outcomes including device-related adverse events up to 30 days post-procedure and intraoperative vessel patency at first attempt and prior to closure. Additional assessments include procedure times, suturing details, and technical success. The study runs from 2025 to 2027, with ongoing monitoring during the procedure and follow-up visits.

Researchers are gathering detailed real-world information on people with chronic wounds and ulcers to better understand their medical journey and treatment outcomes. This observational registry collects data from over 1,400 healthcare providers across the USA and Puerto Rico using a specialized electronic health record system. It includes all major wound types such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, arterial ulcers, surgical wounds, traumatic wounds, and inflammatory ulcers. Participants receive care as usual from their clinicians, who use standard and advanced wound treatments like specialized dressings, compression therapy, offloading devices, cellular and tissue-based products, negative pressure therapy, ultrasound therapy, topical oxygen, hyperbaric oxygen, growth factors, debridement, and topical antibiotics. Data on treatment practices, wound characteristics, patient health conditions, and complications are collected continuously during routine care. Patients may be followed for over five years to track long-term outcomes. During the study, researchers collect information on patient demographics, wound details, treatment methods, visit frequency, and complications. They monitor healing progress, amputations, deaths, wound recurrence, hospitalizations, and other outcomes. The registry uses a wound healing index to adjust for risk and supports quality improvement and research by linking clinical data with insurance claims for comprehensive analysis. This ongoing effort helps to better understand wound healing and treatment effectiveness in everyday healthcare settings.

Researchers are studying the long-term quality of life outcomes in patients with lymphedema who either choose to have surgery using vascularized lymph node transfer VLNT or opt for non-surgical management. The study aims to compare these two groups to better understand the impact of surgical versus non-surgical treatment on patient well-being. This observational study is sponsored by Memorial Sloan Kettering Cancer Center and focuses on adults with primary or secondary lymphedema affecting the upper or lower limbs. Participants are divided into two groups based on their treatment choice those who undergo VLNT surgery and those who receive non-surgical care. There is no additional treatment or intervention during the study follow-up period the research simply observes and assesses quality of life over time. The study uses established questionnaires such as the Upper Limb Lymphedema ULL-27, Lymphedema Life Impact Scale version 2 LLISv2, and LYMQOL-Leg to evaluate patient outcomes. During the study, participants complete quality of life assessments up to 40 months after enrollment. There are no therapeutic procedures administered as part of the study itself. The research team monitors patient responses to these questionnaires to measure the impact of different treatment choices on daily living and overall health. The study includes adults between 18 and 80 years old who speak English and meet specific lymphedema stage criteria.

Researchers are evaluating whether a thorough prevention program can help drain lymph fluid from the arm and prevent lymphedema in women diagnosed with breast cancer who undergo axillary lymph node dissection. The study, sponsored by Memorial Sloan Kettering Cancer Center, is a phase 3 prospective cohort study focusing on reducing lymphedema and improving quality of life after treatment for breast cancer. The program includes immediate lymphatic reconstruction performed during axillary lymph node dissection, followed by self-directed lymphatic massage and range of motion exercises starting 24 to 48 hours after surgery. Participants will also use compression garments daily for at least 8 hours a day for 3 months or until 3 months after completing any additional treatments like chemotherapy or radiation. Arm volume measurements will be taken at each in-person postoperative visit to monitor progress. Participants will be involved in regular follow-up visits for up to 24 months, during which their arm volume will be measured to assess changes from baseline. The study tracks adherence to lymphatic massage, exercises, and compression garment use. Researchers will use these assessments to evaluate the programs effect on reducing arm swelling and improving quality of life after breast cancer surgery.

This research is investigating the added value of reconstructive lymphatic surgery in patients with upper or lower limb lymphoedema. The study compares this surgery combined with usual care, called decongestive lymphatic therapy, to usual care alone. The goal is to see if surgery improves lymphoedema-specific quality of life 18 months after treatment. Lymphoedema is a chronic condition causing limb swelling and physical and mental challenges, impacting daily function and work ability. Participants are randomly assigned to one of two groups one group receives reconstructive lymphatic surgery, which may include lymphovenous anastomosis, lymph node transfer, or both, plus usual care. The other group receives usual care alone, consisting of maintenance decongestive lymphatic therapy including skin care, compression garments, exercises, and manual lymph drainage. Surgery choice is based on each patients condition following a surgical algorithm. During the study, participants will undergo assessments at various time points up to 36 months. These include quality of life questionnaires, limb volume measurements, physical activity monitoring, work capacity evaluations, and tracking of compression garment use. Researchers will also monitor infections, surgery complications, lymphatic transport, and costs related to lymphoedema. The main outcome is quality of life related to lymphoedema at 18 months. Follow-up continues to evaluate longer-term effects and safety.

This research investigates the effects of an Aescin-based herbal extract called Reparil compared with Ibuprofen in managing symptoms after surgical removal of impacted lower wisdom teeth. The study focuses on people aged 18 to 40 who undergo this common oral surgery, aiming to find out if the herbal treatment offers pain relief and reduces swelling and limited mouth opening with fewer side effects than traditional nonsteroidal anti-inflammatory drugs NSAIDs. Participants will be randomly assigned to receive either Reparil tablets containing 20 mg Aescin or 400 mg Ibuprofen tablets, each taken orally three times a day for five days after surgery. Both groups follow the same schedule, and a rescue pain medication is available if needed. Assessments will occur before surgery and on days 2 and 7 afterward to measure pain, facial swelling using 3D scanning, and mouth opening using a digital caliper. During the study, participants will have their pain levels, facial swelling, and jaw movement tracked at specific intervals. Researchers will record any adverse effects and analyze data to compare the treatments impacts. The total involvement includes the surgery and follow-up visits on days 2 and 7, helping to evaluate the herbal extract as a potential alternative to Ibuprofen for managing post-surgical symptoms.

Researchers are investigating how to develop a detailed and practical algorithm to guide surgical treatment for chronic lymphedema that occurs after breast cancer surgery. This observational study aims to fill the current gap in evidence-based recommendations by analyzing data from patients who previously underwent breast cancer-related surgery and later developed lymphedema. The goal is to improve treatment decisions and patient quality of life while supporting insurance coverage approval through stronger scientific data. The study involves reviewing past cases of patients who had chronic lymphedema lasting more than three months and underwent one or more specific surgical procedures for this condition. These procedures include Lymph Node-Vein Anastomosis, Lymphaticovenous Anastomosis, Tumescent Liposuction, Vascularized Lymph Node Transfer, and Water-Assisted Liposuction. Researchers will analyze these surgical treatments and their outcomes to create the Basel Lymphedema Protocol as an evidence-based surgical guideline. Participants data will be collected retrospectively, including details such as surgery dates, type and duration of surgery, lymphedema stage and location, use of compression stockings, and postoperative complications. The study will assess patient characteristics, tumor information, and follow-up results to understand treatment effects better. This comprehensive evaluation will allow researchers to design an integrated algorithm by the end of 2024 and ultimately improve personalized surgical care for chronic lymphedema after breast cancer treatment.

Researchers are evaluating whether artificial intelligence AI can help doctors detect broken bones, joint effusions, dislocations, and bone lesions more quickly and accurately in emergency room settings. This prospective, randomized, controlled trial compares traditional diagnostic methods to AI-assisted X-ray interpretation. The study also aims to see if AI can save time and reduce healthcare costs while improving clinical workflows in orthopedic emergency care. Participants will be assigned to one of two groups one using standard physician interpretation of X-rays without AI assistance, and the other using AI tools Aidoc or Gleamer BoneView integrated into the hospitals imaging system to highlight potential injuries in real time. Both groups will receive standard X-ray imaging of injured arms or legs. The AI serves as a diagnostic aid, with physicians making final diagnoses. The study includes around 4,800 patients presenting with isolated extremity injuries or joint complaints. During the study, participants will undergo routine X-ray imaging and have their images reviewed with or without AI support depending on group assignment. Researchers will collect baseline demographic and clinical data and assess diagnostic accuracy, time to diagnosis, physician confidence, and cost efficiency. Diagnoses will be independently reviewed by experts to ensure accuracy. The study adheres to ethical guidelines and requires informed consent from participants. Results may inform future use of AI in emergency care settings.

Researchers are evaluating the precision of the complete crown technique for superimposing 3D digital models to measure changes in gingival tissue volume. This technique was introduced in an earlier in-vitro study as a way to accurately and simply quantify gingival recession. The study focuses on patients scheduled for esthetic crown lengthening, comparing this new method to the gold standard technique for digital volumetric assessment in the esthetic zone. The study involves taking a digital intraoral scan before surgery T0 and another scan 6 months later T6. Both scans will be processed using specialized software where the models will be trimmed, repaired if needed, and aligned using either the complete crown technique or the gold standard method. The complete crown technique selects the crown of the tooth near the gingival margin, while the gold standard uses surrounding teeth and palatal gingiva. Accuracy of superimposition will be assessed with heat maps and further analyzed with 3D measurement software. Participants will undergo baseline and 6-month follow-up scans to monitor gingival volume changes and superimposition accuracy. Researchers will carefully check model quality and use software tools to measure alignment precision and tissue changes. The primary outcome is superimposition accuracy at 6 months, with secondary outcomes including marginal and volumetric tissue changes. The total study duration for each participant is 6 months, with follow-up visits for digital assessment and monitoring.