Clinical Research Directory

Evaluating the Efficacy of NeoThelium FT in the Treatment of Pressure Injuries

This is a randomized controlled trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating pressure injuries.

Predictive Validity and Clinical Utility of an Ultrasound-based Quantitative Risk Score for Pressure Injury in Critically Ill Patients

Pressure injuries are a common and serious complication for critically ill patients in the intensive care unit (ICU). Early and accurate identification of high-risk patients is crucial for effective prevention. This two-phase sequential study aims to evaluate a new, objective assessment tool: an ultrasound-based quantitative risk score. Phase 1 is an observational study designed to test the predictive validity of this ultrasound score. Researchers will use bedside ultrasound to examine tissue integrity and determine how accurately the score can predict the development of pressure injuries. Phase 2 is a pilot randomized controlled trial. In this phase, patients will be randomly assigned to receive either standard preventive care or a targeted nursing intervention guided by the ultrasound score. The primary goal is to assess the clinical effectiveness of this score-guided intervention in reducing the occurrence of pressure injuries and improving nursing care for critically ill patients.

Comparison of the Effectiveness of Fluidized Positioner and Memory Foam Pillow in the Prevention of Pressure Injury in the Children's Head

This study aims to compare the effectiveness of fluidized positioners and memory foam pillows in preventing pressure injuries in the head among pediatric patients. H1: There is a significant difference between the fluidized positioner and the memory foam pillow in terms of pressure injury incidence in pediatric intensive care patients. H2: The fluidized positioner reduces the risk of developing pressure injuries more effectively than the memory foam pillow. H3: There is a significant difference in the pressure applied to the head region of the patient between the fluidized positioner and the memory foam pillow. H4: The anatomical locations of pressure injuries (occipital, parietal, temporal, and ear regions) vary depending on the type of pillow used. H5: Compared to the memory foam pillow, the fluidized positioner is associated with a more homogeneous pressure distribution across the occipital, parietal, and temporal regions.

The Effect of a Color-Coded System on Pressure Injury Prevention in the Intensive Care Unit

This study is designed as a randomized controlled trial to examine the effect of using a color-coded classification system that identifies the risks of pressure injuries in the intensive care unit on the development of pressure injuries.

Using Music During Wound Care Among Seniors With Pressure Injuries

Pressure injuries (also known as pressure wounds or bed sores) are increasingly common among older adults living in care homes. These wounds often require regular dressing changes, which can be uncomfortable for some. The researchers believe that listening to music during wound care may have an effect on pain, wound healing, and the overall wound care experience, compared with wound care without music. The goal of this clinical study is to test this idea by examining whether listening to music before and during wound care is linked to differences in pain, wound healing, and the overall wound care experience in older adults with pressure injuries. The main questions this study aims to answer are: Does listening to music before and during pressure injury care affect pain during wound care? Does listening to music before and during pressure injury care affect how pressure injuries heal over time? Does listening to music affect the overall experience of pressure injury care? Researchers will compare wound care with music to wound care without music to better understand whether music makes a difference. The study will take place in eleven long-term care homes in Ontario. Participants will be residents aged 60 years and older who have a stage II, III, or IV pressure injury and who are already receiving regular wound care as part of their usual care. This study will not include residents who have infected or necrotic wounds, or who are at the end of life. Participants will continue to receive the same wound care they would normally receive. Some homes will include music during wound care, and some homes will not. Participants in homes using music will: Listen to a playlist of music they personally enjoy for about 15 minutes before wound care begins Continue listening to the music during the wound care procedure Be able to change the volume or stop the music at any time Participants in homes not using music will receive the same standard pressure injury care without music. Information for the study will come from clinical records that nurses already complete during routine wound care, such as notes about pain and wound healing. Staff involved in playing the music will also complete a short questionnaire about their observations of the wound care experience. Photos of wounds that are already taken as part of usual care may be reviewed to look at healing over time. Participants may take part in the study for up to six months or until their wound has healed. Taking part is voluntary, and participants or their decision-makers can choose to stop at any time. The study does not change the medical care participants receive.

Myriad™ Augmented Soft Tissue Reconstruction Registry

This is an observational study designed to evaluate the safety and clinical outcomes of Myriad™ in soft tissue reconstruction procedures. The study will enroll participants who are undergoing a surgical procedure, where the attending physician will use Myriad™ as part of the surgical intervention.

Prediction of Pressure Injury Risk in ICU Using Data Mining

This study is a retrospective record review conducted among adult patients hospitalized in the intensive care unit of a tertiary hospital between October 10, 2020, and October 10, 2025. The aim of the study is to predict the risk of pressure injury development using demographic, clinical, laboratory, and nursing care-related variables by applying multiple data mining algorithms. No intervention, treatment, or patient contact will occur. All data will be extracted from existing electronic and paper-based medical records and will be fully anonymized prior to analysis. The study poses no risk to participants and will be conducted with approval from the institutional review board or ethics committee.

Skin Change Actions by Nursing

Pressure injuries, local areas of damage to the skin and underlying soft tissue that are costly and painful, are often preventable with timely use of prevention strategies. Identifying early pressure induced tissue damage among nursing home residents by nursing staff during routine skin assessment is critical for this process. Finding early damage can prompt nursing home staff to start prevention actions and may allow viable tissue rescue, reducing other health problems or death. We propose use of sub-epidermal moisture (SEM) measures as the cue for nursing home staff to start prevention care. SEM provides early detection of skin damage by as much as 5 to 10 days prior to other methods, eliminates the inherent structural bias in visual skin assessment for residents with dark skin tones, and demonstrates a model of care using technology innovation in poorly-resourced healthcare settings to provide bedside, real-time, point-of-care feedback that is can be used immediately by nursing staff. In this study, nursing staff will use a device (the Provizio SEM Scanner) as part of standard skin assessments. The staff will use the values from the Provizio SEM Scanner during these assessments to decide if residents need preventive care for their skin. The study will look at these decisions and residents' subsequent health outcomes. The study will also use information about residents' skin health and prevention actions during the 52 weeks before the study as a comparison.

Digital Twin-Haptic Integrated Mixed Reality Simulation

The responsibility for the management of pressure injuries belongs to nurses; the development of pressure injuries indicates that nursing care is not adequate. Pressure injury management should be addressed starting from undergraduate education in line with current guidelines. However, programs in which traditional education methods are used in pressure injury management are insufficient. Therefore, pressure injuries should be addressed with a structured simulation practice integrated with advanced technological methods. Any study using mixed reality in pressure injury management was not found in the literature. There is a study using augmented reality with a smartphone to measure wounds and a study examining the effectiveness of augmented reality in leg ulcer care. The use of mixed reality simulation in pressure injury management is one of the unique values of the project. Within the scope of the project, anchoring and monitoring physical objects in all application steps in pressure injury management and creating a digital twin is the most important original value of this project, which is that the student is immersed in the virtual reality environment in real-time and experiences all the processes physically-haptically. The digital twin-haptic integrated mixed reality simulation proposed in this project will contribute to the pressure injury literature and education by increasing the retention of information in memory and providing a realistic experience to the student, as it appeals to both visual, auditory, and tactile senses. The main aim of this project is to develop a digital twin-haptic integrated mixed reality simulation in pressure injury management and to compare the effect of the developed digital twin-haptic integrated mixed reality simulation and the high reality simulation in the institutional infrastructure on the students' knowledge level, skill performance, perceived learning level, satisfaction, and confidence level in learning. The project is planned as a randomized and comparative type and will last 24 months. A total of 130 second-year nursing undergraduate students will be stratified and randomized into the digital twin-haptic integrated mixed reality simulation and high-fidelity simulation groups based on their course grades and gender. Data will be collected using tests and scales. In terms of project management, the project has been handled in four phases with six work packages; in the first preparation phase, validity and reliability studies of the data collection tools, scenarios, and theoretical training module developed by the project team will be carried out, and participant randomization will be carried out. In the second phase, simulation laboratories will be prepared. In the third stage, the mixed-reality simulation software will be created and tested. In the last stage, pre-test application, training with the theoretical training module, simulation application, post-test, and follow-up will be carried out. Data will be analyzed using SPSS®23. All work to be carried out within the scope of the project is defined concretely and according to the workflow, and who/s will carry out each work is defined according to the field of expertise. All possible risks that may be encountered during the project have been foreseen, and measures for risk management have been prepared as Plan B. Within the scope of the project, importance was given to the use of the facilities, infrastructure, and equipment available in the institution. Within the scope of the project, the digital twin-haptic integrated mixed reality simulation will be developed entirely with national resources and registered. The mixed reality simulation software will be commercialized for educational purposes. In addition, with the use of the digital twin-haptic integrated mixed reality simulation program in the management of pressure injury, the quality of education in the field of health will increase, and the IT infrastructure of the training curricula will be supported, and a standard will be provided throughout the country, thus creating a sufficient and qualified workforce in this field. As a result of this qualified training, it is predicted that pressure injury rates will decrease and patient safety will increase in the long term. With the mixed reality simulation program, the leadership power of our country in the international arena, its potential, and recognition in the field of education and technology will be increased.

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure Ulcers

This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Chronic Pressure Ulcers

Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic

Spinal cord injury (SCI) is a permanent condition affecting every aspect of life including health, daily activities, and participation and quality of life. Persons with SCI are at high risk of pressure injury (PrI) throughout their lives due to loss of sensation, nerve damage and immobility. PrIs are local areas of damage to the skin and underlying soft tissue caused by pressure and shear commonly located over bony prominences. While most PrIs are hospital- or nursing home-acquired, in people with SCI, PrIs typically develop in the community. Community-acquired pressure injuries (CAPrIs) are common, devastating, and costly. This grant proposal will assess how well a decision support tool, called the Community Acquired Pressure Injury Prevention Field Implementation Tool (CAPP-FIT), is used in the clinic and how well it prevents CAPrIs. The CAPP-FIT will be implemented at seven sites across the country in a staggered fashion. The CAPP-FIT includes: 1) an automated Veteran survey to identify risks, actions, and resources needed to prevent CAPrIs and 2) a companion Provider Report immediately available in the electronic health record listing Veteran responses to survey items with recommended evidence-based provider actions. The Veteran survey can be completed via a secured email on the computer or phone. There are three aims in the proposal: Aim 1 is implementing the CAPP-FIT at the seven geographically diverse VA SCI clinics. After CAPP-FIT implementation, each site will determine how the CAPP-FIT will be maintained in clinical practice to support sustainability. Aim 2 assesses how well the CAPP-FIT prevents CAPrIs and CAPrI-associated hospitalizations and assesses provider and Veteran satisfaction. Aim 3 assesses how well the CAPP-FIT is implemented in the SCI clinic.

Zinc Oxide VS MEBO

randomize control trial to evaluate the efficacy of using zinc oxide versus moist exposed wound ointment in treatment of second stage pressure ulcer.

A Real-World Registry of Chronic Wounds and Ulcers

WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers. Data are collected during routine care from over 1,400 clinicians across the USA and Puerto Rico using a highly structured certified electronic health record (EHR) or electronic data capture (EDC) system. Data are transmitted daily to the U.S. Wound Registry (USWR), a CMS-recognized Qualified Clinical Data Registry (QCDR). The registry captures real-time, research-ready data on patient demographics, comorbidities, wound characteristics, standard-of-care treatments, complications, and advanced therapeutics. It supports robust, fit-for-purpose real-world evidence generation by enabling risk-adjusted outcome analysis, comparative effectiveness research, and quality improvement across diverse sites of care.

The Influence of Standardized Process Management of Laryngeal Mask Airway Placement Based on Pressure Monitoring on the Incidence of Adverse Reactions in Elderly Patients During the Perioperative Period

The laryngeal mask airway (LMA) is a supraglottic ventilation device designed according to human anatomy. It was developed in 1981 by Dr. Archie Boubrain in the United Kingdom to compensate for the deficiencies of tracheal intubation and mask ventilation. It has been widely used in clinical practice because of its simple operation, small airway stimulation, and hemodynamic stability. In 1990, LMA entered the Chinese market. In 1993, LMA was included in the American Society of Anesthesiologists guidelines for the emergency management of the difficult airway. In the past, tracheal intubation was the standard method of airway control during general anesthesia. In the past decade, the proportion of LMA ventilated general anesthesia has increased significantly in China and European and American countries. By 2022, the utilization rate of LMA in China climbed to 95.96%. With the continuous improvement and development of LMA, it can be used to establish safe airway management in special positions such as lateral position and prone position, long-term surgery and special site surgery. However, the wide application has also exposed some key problems. The lack of standardized process management of LMA placement may lead to improper placement, airway obstruction, laryngspasm, reflux, and aspiration during the application of LMA, which may cause a series of pulmonary and extrapulmonary complications. Studies have shown that many adverse events during LMA implantation may be related to LMA pressure monitoring. Inadequate pressure monitoring may lead to pressure imbalance, and improper pressure management may lead to poor coordination between LMA and pharynx. Coupled with the change in intraoperative position and postoperative transfer, the risk of postoperative sore throat and LMA displacement increases. Therefore, there is an urgent need for standardized process management, dynamic pressure monitoring and position adjustment during the use of LMA. The standardized management of LMA insertion involves the standardized selection, placement, maintenance management and transportation of LMA. Especially for the elderly population, LMA displacement is more likely to occur due to the atrophy of pharyngeal mucosa and muscle, weakened cough reflex, and decreased chest wall compliance, which increases the incidence of pulmonary and extrapulmonary complications. For elderly patients with atherosclerosis, LMA displacement and relatively high cuff pressure may compress the jugular and jugular veins in the neck and surrounding tissues, increasing the risk of stroke in elderly patients. Effective and safe anesthesia airway and respiratory management strategies during general anesthesia will directly affect the occurrence of postoperative pulmonary complications (PPCs) and the incidence of sore throat in elderly patients. Standardized management of LMA and continuous pressure monitoring and adjustment can improve the above adverse reactions. At present, there is a lack of large-scale and reliable evidence-based medical evidence to evaluate the effect of standardized process management of laryngeal mask insertion based on pressure monitoring on perioperative adverse reactions in elderly patients with high risk of pulmonary complications. Especially in the elderly population with a high incidence of PPCs, the safety, short - and long-term advantages and disadvantages of widespread use of LMA ventilation are still unclear. Therefore, it is particularly urgent to carry out the effect of standardized process management of laryngeal mask insertion based on pressure monitoring on perioperative adverse reactions in elderly patients, and to further explore the appropriate range of laryngeal mask related pressure indicators. This study based on the concept of enhanced recovery after surgery (ERAS) can not only fill the current research gap, but also provide strong support for safe and efficient airway management in elderly patients during the perioperative period, and effectively promote the further optimization of clinical practice, which has extremely important clinical significance and practical value.

Effectiveness of Platform-Based Lateralization Therapy in Reducing Interface Pressure Between The Patient And The Support Surface

Pressure injury (PI) is characterized as damage to the skin and/or underlying tissues resulting from sustained pressure or a combination of pressure and shear forces between the patient and the support surface. Prolonged pressure is a well-established risk factor in the development of PIs. Frequent repositioning and routine patient care have been recognized for decades as integral components of PI prevention and treatment protocols. The duration of interface pressure is as critical as its magnitude. When interface pressure exceeds the mean capillary blood pressure, blood flow can be compromised, leading to ischemia in affected areas, which may progress to necrosis if sustained over time. Furthermore, it is widely accepted in the literature that tissue becomes at risk when interface pressure exceeds 30 to 32 mmHg. In this context, continuous lateral rotation therapy (CLRT) offers a potential alternative for managing critically ill patients. CLRT involves continuous mechanical rotation of the patient in the lateral plane. However, its effects on skin integrity remain poorly understood. Despite the rationale behind and widespread recommendation of repositioning, the lack of robust evaluations on how repositioning impacts interface pressure creates uncertainty, underscoring the need for high-quality trials to assess different strategies for implementation. Although lateralization is a pragmatic strategy for preventing pressure injuries, its use in critically ill patients requires an integrated assessment of respiratory, hemodynamic, and gastroesophageal effects. Therefore, this study proposes an innovative approach by evaluating, for the first time, the effectiveness of automated postural change with simultaneous monitoring of tissue integrity, pulmonary function, cardiovascular stability, and gastroesophageal protection. The aim is to optimize pressure injury prevention, improve pulmonary mechanics, ensure hemodynamic stability, and preserve gastroesophageal safety in critically ill patients.

Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Matched Standard of Care Controls in the Management of Nonhealing Pressure Ulcers

The purpose of this study it to evaluate several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.

Adaptation of the Intensive Care Unit-specific Pressure Injury Risk Scale to Turkish (RAPS-ICU)

The aim of this study was to evaluate the translation, cross-cultural fit, and psychometric properties of the ICU-specific pressure injury risk scale

Mobile Application-Assisted Pressure Injury Management

Pressure injuries develop due to decreased movement, especially in bedridden individuals receiving home care. In Turkey, the management of pressure injuries is carried out by nurses in acute and long-term care settings, and mostly by caregivers for individuals receiving home care. Studies have shown that individuals providing home care have a significant need for training. Today, digital health technologies are used to facilitate access to healthcare professionals and provide workload and cost efficiency. Telehealth services in these technologies can be provided via telephone or mobile applications. In this context, the aim of the study is to examine the effect of nursing services provided via mobile applications on the management of pressure injuries in individuals receiving home care. The study was designed as a randomized controlled experimental type. In the power analysis conducted to calculate the sample size, the sample size was determined as 56, and considering that there may be data losses, 60 people will be included in the study. The "Structured Information Form, Pressure Injury Information Form for Caregivers, Pressure Injury Skill Checklist for Caregivers, and Pressure Injury Follow-up Form" will be used as data collection tools in the study. In this study, it is thought that the nurse's remote monitoring of individuals receiving home care with a mobile application in the management of pressure injuries will contribute to patient safety and care costs.

Telemedicine Wounds

This study aims to explore the effectiveness of the flipped education model applied to distance digital learning in enhancing the pressure injury staging interpretation skills of long-term care nursing staff. A quasi-experimental design was employed, dividing participants into a flipped education group and a conventional digital learning group. Pre- and post-intervention assessments were conducted to evaluate knowledge and skills, and differences in satisfaction and cognitive load were compared.

Development of a Nursing Care Bundle to Prevent Pressure Injuries and Its Impact on Rates and Costs

Pressure injuries (PIs) represent a significant clinical complication for patients worldwide and pose financial and quality challenges for healthcare systems. These wounds, which are highly challenging to treat and care for both patients and caregivers, lead to physical and psychological trauma, negatively affect daily life activities, reduce quality of life, and increase care costs (Padula et al., 2019; Yilmazer \& Tüzer, 2022). Moreover, the expenses associated with treatment are 2.5 times higher than those for prevention (Lyder \& Ayello, 2007). Additionally, they often prolong hospital stays and increase the time nurses spend on care (Yilmazer \& Tüzer, 2022). According to the National Pressure Injury Advisory Panel (NPIAP, 2019), providing high-quality care for patients with PIs requires adopting a multidisciplinary, standardized care approach tailored to the specific needs of patients (Heasler, 2019). Past and current literature supports the use of evidence-based care bundles to reduce PIs (Coyer et al., 2015; Chaboyer et al., 2015; Amr et al., 2017; Deakin et al., 2020; Yilmazer \& Tüzer, 2022; Wang et al., 2023). A care bundle is a critical element for standardizing and enhancing the quality of nursing care through the utilization of evidence-based clinical practice guidelines by healthcare professionals. Therefore, adopting these evidence-based approaches will improve the consistency and quality of nursing care, enhance patient outcomes, and reduce institutional costs. Moreover, the use of care bundles during interventions promotes teamwork and collaboration while supporting the development of a common language (Anderson et al., 2015; Institute for Healthcare Improvement, 2021). This study aims to reduce PIs, enhance the quality of patient care, lower healthcare costs, and improve overall patient outcomes through the development and implementation of a nursing care bundle based on evidence in the literature. The widespread use of the care bundle, grounded in achieved outcomes, will contribute to the prevention of PIs. Additionally, it will serve as a supportive tool for nurses to improve the quality of care.

Diagnostic Precision and Accuracy Using the Teed Scoring System Versus the O'Neill Grading System

This validation study investigates the diagnostic precision and accuracy when grading otic barotrauma using two alternative gradings systems including the TEED and the OGS grading systems. Background There are two grading systems used to grade otic barotrauma. They include the Teed Score (TEED) and the O'Neill Grading System (OGS). Teed has been utilized more extensively but among physicians has been found to have limitations. The OGS is an alternative grading system with less classification categories than what the Teed classification system utilizes. The OGS system is tied directly to treatment decision making, specific to the respective grading level. Methods This study will utilize a sample of clinical examiners who will independently grade 120 digital color photos of actual patient tympanic membranes with and without evidence of eustachian tube dysfunction and middle ear barotrauma including variable stages or grades of otic barotrauma. They will use the TEED chart as a reference in selecting the appropriate TEED score for each of the photos. Simultaneously they will also utilize the OGS chart as a reference in selecting the appropriate OGS grade for each of the photos. The grading will be conducted by physicians, nurses, and technicians. This will allow for comparisons at varying provider levels. The comparisons will be made using the kappa statistics across the disciplines. This will allow comparison between observed agreement, and expected agreement due to chance for all reviewers. Research Hypothesis Ho: There is no difference in diagnostic precision and accuracy when grading otic barotrauma between clinical examiners using either the TEED or OGS grading systems. Ha: There is a difference in diagnostic precision and accuracy when grading otic barotrauma between clinical examiners using either the TEED or OGS grading systems.

Prevent Medical Device-Related Pressure Injury

Medical Device-Related Pressure Injury (MDRPI) is a localized skin and/or subcutaneous tissue injury that occurs due to the pressure exerted by devices used for diagnostic or therapeutic purposes, taking the form of the medical device used. Medical device-related pressure injuries are an important adverse event with a high incidence and prevalence both in our country and in the world, accounting for more than 30% of hospital-related injuries. Medical device-related pressure injury significantly affects the quality of life of patients, but also negatively affects the cost of care for both the patient and providers. Although the most important task in preventing medical device-related pressure injuries falls on nurses, it is quite noticeable that nurses' knowledge levels of MDRPI are low in the studies conducted. MDRPI is an important issue that is ignored in nursing education and work areas in our country. In order to prevent pressure injuries associated with medical devices, it is necessary to invest more in early detection of MDRPI and improving the quality of care, studies including MDRPI risk assessment and reporting strategies are needed. In the project to be carried out in this context, it is aimed to evaluate the impact of training applied to nurses to prevent MDRPI.

Comparing Aloe Vera Gel and Rosemary Oil in Pressure Injury Prevention

Most patients admitted to the orthopedic ward are at risk of developing pressure ulcers. Today, the tendency to use medicinal herbs in pressure ulcer treatment has increased due to the variety of effective compounds and their fewer side effects.

Digital Multimedia in Clinical Nurse Education for Pressure Injury Prevention Via LINE@

The goal of this clinical trial is to integrate past indicators affecting the effectiveness of pressure injury care education among nurses and to explore the learning outcomes of nurses through different educational interventions. The main questions it aims to answer are: What are the outcomes of nurses' knowledge, attitudes, and self-efficacy in preventing pressure injuries after receiving education through traditional media? What are the outcomes of nurses' knowledge, attitudes, and self-efficacy in preventing pressure injuries after receiving education through digital multimedia combined with practical courses? What is the satisfaction level of nurses with pressure injury prevention education after receiving education through traditional media or digital multimedia combined with practical courses?