Clinical Research Directory

Hypertrophic Scar Prosthetic Pressure in Burn Amputee

Amputation following burn injury is rare but complex, affecting predominantly younger individuals with extensive burns, particularly electrical injuries, and often resulting in residual limbs characterized by scarring, contractures, grafted or flapped tissues, and heightened vulnerability to skin breakdown. Prosthesis-covered burn scars often appear to heal better than uncovered areas, suggesting a potential therapeutic pressure effect; however, excessive localized peak pressures may also contribute to recurrent wounds in grafted or scarred tissues. This study aims to quantify prosthesis-induced pressures on the residual limbs of burn-injured amputees and evaluate the feasibility and reliability of applying pressure measurement tools validated in burn care to this distinct clinical context.

Abdominal Massage and Range-of-motion Exercise in Enterally Fed ICU Patients With Pressure Injuries

The purpose of this study is to evaluate whether two nursing interventions, lower abdominal massage and range-of-motion (ROM) exercises (gentle movements of the arm and leg joints), affect the healing of pressure injuries (bed sores) in intensive care patients who are fed through a tube (enteral nutrition). Intensive care patients often stay in bed for long periods and are at high risk of pressure injuries. Adequate nutrition is important for wound healing, but tube-fed patients often have digestive problems such as constipation, vomiting, bloating, or food remaining in the stomach, which can interrupt feeding. The main question this study will address is: Compared with routine care, do lower abdominal massage or ROM exercises affect digestive tolerance, nutritional markers, and pressure injury healing in tube-fed intensive care patients? The researchers hypothesize that lower abdominal massage may reduce digestive problems and support uninterrupted feeding, and that ROM exercises may support circulation and tissue healing. Both effects may, in turn, support pressure injury healing. Adult patients who have a pressure injury and receive enteral nutrition in the intensive care units of a state hospital in Türkiye will be randomly assigned to one of three groups: * Group 1: lower abdominal massage in addition to routine care * Group 2: ROM exercises in addition to routine care * Control group: routine care only The interventions will be applied for 15 minutes once a day for 7 days. Digestive tolerance (bowel movements, gastric residual volume, nausea, vomiting, abdominal distension), serum albumin, and pressure injury healing (Pressure Ulcer Scale for Healing, PUSH) will be monitored daily. Detailed Description This is a three-arm, parallel-group, randomized controlled experimental study planned for the intensive care units of a secondary-level state hospital in Türkiye. Patients who meet the eligibility criteria will be allocated to lower abdominal massage, ROM exercise, or routine care using a computer-generated randomization list (Microsoft Excel). The sample size will be calculated with G\*Power before data collection (planned minimum: 90 patients; effect size 0.20, alpha 0.05, 95% confidence level). Interventions: Lower abdominal massage (15 minutes: superficial effleurage, palm petrissage, fingertip vibration, closing effleurage; clockwise along the colon, with hands warmed in liquid paraffin) will be performed by an intensive care nurse. ROM exercises (flexion-extension, abduction-adduction and rotation of the upper and lower limb joints, with the patient supine; 3 repetitions per movement, held 30 seconds at the point of resistance; 15 minutes in total) will be performed after the researchers receive ROM training from a physiotherapist. The control group will receive routine intensive care only (nasogastric tube position checks, monitoring of gastric residual volume, defecation, nausea and vomiting, daily Braden Scale assessment, two-hourly repositioning, and stage-appropriate topical wound care). Data will be collected daily at 10:00 using a Patient Information Form and an Intervention/Control Group Patient Monitoring Form. Gastric residual volume will be assessed between 02:00 and 04:00 when feeding is paused. Planned analysis: Normality will be assessed with skewness and kurtosis values (±3). Between-group comparisons will use chi-square/Fisher's exact test, one-way ANOVA or Kruskal-Wallis test with post hoc tests. Within-group changes over time will use repeated-measures ANOVA, Friedman test, or Cochran's Q test as appropriate (significance p\<0.05).

Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)

To examine the effects of Physical Therapist (PT) wound care modalities (pulsed wound irrigation (PWI) + electrical stimulation (ES), PWI only, and ES only) on wound healing in patients with spinal cord injuries (SCI).

The Effect Of Low-Fidelity Simulation Education Pressure Injuries

The nursing education curriculum comprises both theoretical and practical courses designed to educate and prepare nursing students for their professional roles, functions, and responsibilities. Simulation, in particular, offers nursing students the opportunity to practice various essential clinical skills and decision-making processes in a safe environment, without posing an immediate risk to patients. Simulation-based training has been reported to be effective in teaching about pressure injuries. While the significance, staging, and care and treatment approaches regarding pressure injuries are addressed theoretically within nursing curricula, it is not always possible to provide all students with the opportunity to observe and experience pressure injuries at various stages in clinical practice settings. Therefore, teaching the stages of pressure injuries and the associated care and treatment processes through simulation applications in a laboratory setting is considered a significant educational strategy. This study aims to determine the impact of low-fidelity simulation training on nursing students' knowledge levels regarding pressure injuries and their satisfaction with the learning experience.

Effect of Positioning Protocol on Skin Pressure Injury and Shoulder Traction Pain in Neurosurgical Patients

This study evaluates a modified lateral decubitus positioning method designed to prevent pressure injuries and reduce shoulder traction pain in patients undergoing neurosurgical procedures under general anesthesia. Participants will be randomly assigned to either the modified positioning group or the conventional positioning group. The main goal is to compare the incidence of Stage I pressure injuries (per NPUAP criteria) at the end of surgery and the severity of shoulder pain (measured by VAS) at 24 hours postoperatively. Secondary outcomes include positioning time, healthcare worker satisfaction, and changes in CORN intraoperative pressure injury risk scores. This research aims to provide evidence-based guidance for optimizing intraoperative nursing care and improving patient safety and comfort in the operating room.

Research and Application Evaluation of Accurate Pressure Ulcer Area Measurement Technology Based on AI Grid Intelligent Recognition: A Self-controlled Study

The goal of this clinical trial is to learn if AI grid image recognition can measure pressure ulcer wound area accurately and efficiently in adult patients with pressure ulcers. The main questions it aims to answer are: * Can AI grid image recognition shorten the single measurement time of pressure ulcer wound area? * Is the wound area measured by AI grid image recognition consistent with the result from traditional manual grid counting? Researchers will compare AI grid image recognition measurement with traditional manual grid counting measurement on the same pressure ulcer wound image collected at a single time point to see if AI recognition achieves comparable accuracy with less operation time. Participants will: * Have standardized transparent grid dressing applied on their pressure ulcer wound * Undergo one-time wound image collection * Receive sequential wound area measurement using both methods on the captured single wound image

Evaluation of Two Heel Protection Devices to Assess Off-loading Via Pressure Mapping.

The goal of this trial is to compare heel off-loading capabilities of two products

Evaluating the Efficacy of a Tocotrienols-Loaded Dressing in Wound Care for Pressure Ulcers

The goal of this clinical trial is to investigate the effects of the dressing containing Tocotrienols on patients with stage 1 and stage 2 pressure ulcers. The main questions it aims to answer are: * Will the dressing containing Tocotrienols lead to a reduction in the Pressure Ulcer Scale for Healing (PUSH) Score? * Will the dressing containing Tocotrienols help heal the participants' pressure ulcer wounds? * Will the dressing containing Tocotrienols lead to reduction in wound surface area? * What is the percentage of patients with completely healed wounds by the end of the study? Researchers will compare Tocotrienols-loaded formulated dressing to conventional dressing (standard of care as control) in pressure ulcers. Participants will: * Have their pressure ulcers checked by a study doctor to ensure they are infection-free and suitable ulcer fitting the inclusion criteria * Undergo 24-hour allergy testing with patch of Tocotrienol-loaded dressing and standard hydrocolloid dressing * Be randomly assigned to one of three groups if they qualify: control, vehicle-control, or treatment group * Assess skin sensitivity testing the next day, and if qualify, will be started on first dosing. * Attend follow-up visits on days 1, 3, 5, 7, 15, 22, 29, 35 and 43, where additional questions and assessments will be completed.

Manual Lymphatic Drainage on Pressure Injuries

Pressure injuries are a significant health problem, often resulting from pressure, friction, and impaired tissue perfusion, and are particularly common in individuals in intensive care, those with immobility, and those with chronic diseases. The literature extensively addresses interventions such as pressure reduction, the use of appropriate support surfaces, wound care practices, and nutritional support in the prevention and treatment of pressure injuries. However, the role of manual therapies aimed at improving circulation and lymphatic flow, such as manual lymphatic drainage (MLD), in pressure injuries has been examined in a limited number of studies. This research aims to fill a significant gap in the literature by evaluating the potential effects of manual lymphatic drainage on reducing edema, improving tissue perfusion, and supporting the wound healing process in individuals with pressure injuries.

Use of Hydroprep Wound Therapy With Motion Negative Pressure Therapy for Treatment of Chronic Lower Extremity Wounds

Use of a motorized waterjet to debride wounds to improve healing outcomes.

BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation

The study aims to demonstrate the substantial equivalence of the cureVision cV system's performance in detecting moderate to high bacterial loads in direct comparison to the comparator device for fluorescence imaging in wounds, the MolecuLight i:X , to be able to offer the complete cureVision cV system to the US market.

AI-Based Wound Monitoring: Automated Wound Progression Assessment Via Marker-Free Image Sequence

This study aims to develop a low-cost, marker-free intelligent wound assessment system that can analyze wound photos taken with a standard smartphone. By comparing wound images over time, the system will generate a quantifiable Wound Progression Index (WPI) to provide objective feedback on whether a wound is improving, stable, or worsening. The long-term goal is to support early detection of wound deterioration and improve wound care in both clinical and home settings.

Barrier Functions oF Skin in ICU: SKIN-BAR

This study aims to investigate skin barrier function in intensive care unit (ICU) patients using biosensor-based measurements. Biophysical parameters including transepidermal water loss (TEWL), skin pH, stratum corneum hydration, local skin temperature, and sebum will be assessed in anatomical regions at risk for pressure injuries. The study will examine temporal changes in these parameters, their interrelationships, and their association with pressure injury development.

Evaluate the Feasibility and Effectiveness of a Community-based Care Bundle in Managing and Preventing Pressure Injuries

Community-acquired pressure injuries are pressure injuries that developed outside of hospital, typically in the patient's own home environment. Pressure injuries (PI) used to be commonly known as bedsores or pressure ulcers. The goal of this clinical trial is to evaluate if a community-based pressure injury (PI) care bundle is effective in treating and preventing pressure injuries in home settings. It will also assess how feasible it is to implement this care bundle in Singapore's community care context. The main questions it aims to answer are: 1. Does the PI care bundle help improve pressure injury healing (shown by at least a 3-point reduction on the PUSH score)? 2. Can the care bundle prevent the development of new pressure injuries? 3. How well do caregivers learn and apply PI care knowledge after receiving the educational intervention? 4. How practical and acceptable is this care bundle for use in home settings? The investigators will compare the PI care bundle to routine care (control group) to see if the care bundle works better for managing pressure injuries at home. Success will be measured using the PUSH tool, which scores pressure injuries from 0 (completely healed) to 17 (most severe). A reduction of at least 3 points on this scale will indicate meaningful improvement. Participants and their caregivers will: Be split into two groups - one group will use the new care plan (receive the PI care bundle), and the other will continue with their routine care. Have their pressure injuries checked regularly for 6 weeks. Have their caregivers learn about pressure injury care. Answer questions about how well the care plan works for them. The investigator hopes this study will help find better ways to treat or prevent pressure injuries at home and support the caregivers at home.

Effectiveness of an Online Interactive E-book in Enhancing Home Care Nurses' Knowledge, Perceived Barriers, and Self-efficacy in Home Pressure Injury Care

The goal of this study is to learn if an interactive e-book helps home care nurses improve their skills in managing pressure injuries at home. It will also learn if digital learning can overcome the challenges of traditional training. The main questions it aims to answer are: 1. Does the e-book increase home care nurses' knowledge about pressure injury prevention and treatment? 2. Does it improve their confidence and reduce the barriers they face when providing wound care? 3. How long do the learning benefits last after completing the program? Researchers will compare an interactive e-book to standard PDF training materials from the Ministry of Health and Welfare (MOHW) to see which is more effective for nursing education. Participants will: 1. Use an online interactive e-book covering 11 units of wound care for 1 month 2. Use standard PDF training materials from the MOHW Long-term Care section 3. Complete surveys about their knowledge and skills before the study, immediately after the program, and 1 month later Expected Outcomes and Contributions: This study aims to solve the problem of nursing shortages and training difficulties in rural areas. The researchers expect that home care nurses will become more competent in wound management, leading to better patient health and fewer hospital readmissions. These results will support Taiwan's "Long-term Care 3.0" policy by driving innovation in digital education.

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.

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.

Adhesive Devices Versus Elastic Devices for Urinary Catheter Securement in Critically Ill Patients Experimental Study

Nowadays there are two types of urinary catheter securement devices, adhesive and elastic bands. The goal of this clinical trial is to determine which type of device-adhesive or elastic-is more effective for securing urinary catheters in critically ill patients. The study also aims to evaluate the prevention of urethral meatus injuries, patient discomfort, and the incidence of catheter-associated urinary tract infections . The main questions the trial aims to answer are: * Which device type better prevents injuries to the urethral meatus? * Which device reduces discomfort for patients? * Which device lowers the incidence of catheter-associated urinary tract infections? Participants will: * Use either an adhesive or an elastic device to secure their urinary catheter during their stay in critical care * Be monitored regularly to assess any injuries, discomfort, or infections related to the catheter * Provide feedback on their comfort and any complications experienced, if they are able to communicate

Virtual Escape Room Game About Medical Device in Nurses

The research was planned as a pre-test-post-test single-group, quasi-experimental design in order to develop a web-based digital education game to improve nurses' knowledge level on pressure injuries related to medical devices and to evaluate the effect of the developed game on nurses' knowledge acquisition on pressure injuries related to medical devices, as well as the use of the game and user experience. The sample of the research will consist of nurses working in the intensive care unit at Kahramanmaraş Necip Fazıl City Hospital who meet the research criteria and agree to participate in the research. In the first stage of the research, the materials necessary for the game development and evaluation process will be prepared and the content validity study of these materials will be conducted. In the second stage, the development and preliminary evaluation of the virtual escape room game will be done. In the third stage, the virtual escape room game will be applied and data will be collected. Data will be collected from the nurses with the 'Introductory Features Form' and the 'Medical Device Related Pressure Injury Knowledge Level Assessment Test' (pre-test) before the game application; and after the game application, the 'Medical Device Related Pressure Injury Knowledge Level Assessment Test' (post-test) and the Virtual Escape Room Game Evaluation Form. After 4 weeks of the game application (retest), nurses will be asked to answer the questions of the 'Medical Device-Related Pressure Injury Knowledge Level Assessment Test'. H1a: What is the effect of the virtual escape room game on nurses' knowledge levels regarding TCBBY? H1b: What are the usage and user experiences of the virtual escape room game developed for the purpose of educating nurses on the prevention of TCBBY?

Gamified Learning for Pressure Injury Prevention

The goal of this Randomized Controlled Trial is to define the effect of gamified teaching methods for pressure injury prevention in intensive care nurses. The main questions it aims to answer are: H1: The gamified learning experience will increase the nurses' knowledge of pressure injury prevention compared to the control group. H2: The gamified learning experience will increase the nurses' skills in pressure injury prevention compared to the control group. H3: The gamified learning experience will increase the nurses' attitude toward pressure injury prevention compared to the control group. Researchers will compare two arm to see if there is a difference in knowledge, skills, and attitudes. Participants in the experimental group will be educated via a gamified mobile learning application.