Clinical Research Directory

Clinical Registry Collecting Real World Evidence on Wound Care Treatments

The proposed registry Sponsor (Siddhey LLC) will collect data on various wound treatments in real life settings. Data collection will facilitate the analysis of the safety and efficacy of wound treatments.

The Effect of Gamified Metaverse-Based Training on Nursing Students' Self-Efficacy and Metaverse Perception Regarding Pressure Injury Management

Introduction: Pressure ulcers are a largely preventable clinical problem that negatively impacts the quality of patient care and constitutes a significant economic burden for healthcare systems. The prevention and effective management of these ulcers are closely related to nurses' knowledge, skills, and self-efficacy levels. However, current nursing education programs show a limited number of practice-based and interactive training approaches for the prevention and management of pressure ulcers. In recent years, innovative and technology-supported training methods such as gamification and metaverse have emerged as promising approaches for improving students' knowledge and self-efficacy levels by increasing their active participation in learning processes. Aim: The aim of this research is to evaluate the effect of gamified metaverse-based training developed for nursing students on their knowledge level, academic self-efficacy, and metaverse perception regarding pressure ulcer management. Method: The research was planned as a randomized controlled experimental design. The population of the study will consist of students studying in the nursing department. The sample size was calculated using G\*Power based on PUKAT 2.0-T scores; Assuming a two-way α=0.05 and power=0.80, at least 26 participants were selected for each group, and the total sample size was planned as 60 students, taking into account possible losses. Participants will be administered a Demographic Information Form, the Pressure Ulcer Knowledge Level Assessment Tool 2.0-Updated Version (PUKAT 2.0-T), and the Nursing Students Academic Self-Efficacy Scale. Participants will be randomly assigned to intervention and control groups based on their pre-test scores. The intervention group will receive traditional classroom theoretical training and gamified metaverse-based training for two weeks, while the control group will receive traditional classroom theoretical training. Post-tests will be administered immediately after the intervention and one month later. In addition, the Metaverse Perception Scale will be administered to the intervention group. Data will be collected using the Pressure Ulcer Knowledge Assessment Tool 2.0-Updated Version (PUKAT 2.0-T), the Nursing Students Academic Self-Efficacy Scale, and the Metaverse Perception Scale for Nursing Students. Results: The obtained data will be analyzed using appropriate statistical methods. Conclusion: This research is expected to provide evidence regarding the effectiveness of innovative digital education models in nursing education and contribute to the development of educational strategies for the prevention of pressure ulcers.

Prevention of Pressure Injury (PI) in Hospitalised Infants, Children, and Young People (CYP) (Aged 0-19 Years)

What is the problem? Children and young people admitted to hospital can sometimes be harmed by what is called a pressure injury. Pressure injuries are sores (ulcers) that happen on areas of the skin that are under pressure. The pressure can come from lying in bed, sitting in a wheelchair, or wearing a cast for a long time. They usually form on bony parts of the body, such as the heels, elbows, hips, and tailbone. This can be uncomfortable for the patient and distressing for their families. As well, it means that more staff and treatments are needed for the patient. What is known? There is a difference in pressure injury seriousness for infants and children with dark skin tones to those without. Pressure injury care for hospitalised patients starts with an assessment using a tool. In the past, the assessment tools were developed without consideration for differences due to skin tone. This means that the current tools may not be the best way to identify pressure injury for dark skin tones. Healthcare professionals need to make sure that tools are fit for purpose for all. What are investigators going to do? Investigators will work with healthcare professionals, children, and parents together to develop and test the existing pressure injury risk assessment tool for use with dark skin tones. This study is a result of care priority discussions with parents and children. It came from the patients and will benefit the patients. Children, young people, and parents will be involved throughout to ensure their voices are heard. How are investigators going to do it? Investigators will: 1. Look at existing information about pressure injury for children with darker skin tones. If required, investigators will change and increase the accuracy of the existing tool. 2. Test the modified risk assessment tool at 10 children's hospitals in the UK. Investigators will do this to see if it can distinguish hospitalised children with dark skin tones, at high or low risk of pressure injury development during their hospital stay.

Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU

This observational study will evaluate the real-world effectiveness of four amniotic membrane-based products (Zenith™, Orion™, SurGraft FT™, Complete ACA™) in addition to standard care, compared with standard care alone. The study will use complete electronic health records (EHR) from multiple wound care centers across the United States (2022-2025) to generate study data for product-treated and propensity score-matched standard care cohorts for each product-indication combination. The overall study comprises 12 parallel sub-studies (one for each product-wound type combination), each aiming to answer whether adding the product improves healing outcomes versus standard care alone in that indication. The primary endpoint is the proportion of wounds achieving complete closure within 12 weeks, with subgroup analyses by wound severity measures, age groups, and number of product applications. Secondary outcomes are time-to-healing, early wound improvement (≥50% reduction in wound area by 4 weeks), wound-related complications, and subgroup analyses.

HEAL-4: Real-World Effectiveness of 4 Amniotic Allografts Adjunctive to Standard Care in DFU, VLU, and PU

This retrospective multi-site observational cohort study uses electronic health records (EHR) from U.S. wound care centers to evaluate the effectiveness of four amniotic membrane allografts (Acesso DL, Acesso TL, Neostim DL, Neostim TL) when added to standard wound care for diabetic foot ulcers (DFU), venous leg ulcers (VLU), and pressure ulcers (PU). The primary endpoint is complete wound closure by 12 weeks. Secondary outcomes include time-to-closure, ≥50% wound-area reduction at 4 weeks, wound-related complications (infection, hospitalization, emergency department visits, and major/minor amputation).