Clinical Research Directory

Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers

To prospectively evaluate the safety and efficacy of an Autologous Platelet-Rich Fibrin Plasma system when applied in conjunction with Standard of Care for management of chronic lower extremity wounds.

A Real World Data Collection of Human Amniotic Membrane(s) on Diabetic Foot Ulcers, Venous Leg Ulcers, Pressure Ulcers and Post Operative Wounds

This study is designed to evaluate the effectiveness of Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ compared to the effectiveness of Standard of Care alone though a retrospective data collection.

Prevention of Community Acquired Pressure Ulcers Using SSKIN Bundle at Home

Pressure ulcers remain a significant healthcare burden in community and home care settings, particularly among immobile patients. Effective prevention strategies require caregiver education and implementation of evidence-based care bundles. The SSKIN care bundle (Surface, Skin inspection, Keep moving, Incontinence management, Nutrition) is an internationally recognized approach, but its effectiveness when implemented by informal home caregivers using culturally adapted materials remains unclear. This study aimed to compare the knowledge and competency of informal caregivers who received structured training on the SSKIN care bundle versus those receiving traditional verbal instructions, and to evaluate the impact of this training on the incidence of pressure ulcer development in community-dwelling patients at risk for pressure ulcers. Eligible patients were ≥18 years old, at risk for pressure ulcers due to limited mobility (bed-bound or requiring mechanical assistance for repositioning), able to provide informed consent, and receiving home health care services. Eligible caregivers were informal or hired caregivers responsible for daily patient care. Primary outcomes included the caregivers' knowledge of pressure ulcer prevention, assessed via pre-test and post-test questionnaires and the incidence of new pressure ulcers developed during the 6-month follow-up period. Secondary outcome was the mortality rate during the study period.

The Effect of Photobiomodulation on Pressure Ulcers

Photobiomodulation Group (Intervention Group): Before the intervention, the patient's skin sensitivity to light will be tested by applying light for 3 minutes to one-fourth of the forearm skin. If redness occurs and persists for more than 2 hours, this indicates photosensitivity, and the intervention will not be performed. The Patient Information Form will be completed during the first meeting with the patients included in the study. Subsequently, blood values will be determined, the Patient Assessment Form will be filled out, vital signs will be measured, and then the intervention will begin. After routine wound care/cleaning procedures in the intensive care unit, without applying any medication, cream, or lotion to the wound area, red light (660 nm wavelength) will be applied to the wound area for 5 minutes at a distance of 55 cm during the first 3 days, and for 10 minutes at the same distance on the following days. This application will continue once daily for 14 days. Wound assessments will be performed, and photographs will be taken on Day 1, Day 4, Day 7, and Day 14 (Baracho et al., 2021; Viecelli et al., 2024; Lima et al., 2020). Control Group: The Patient Information Form will be completed during the first meeting with the patients included in the study. Subsequently, blood values will be determined, the Patient Assessment Form will be filled out, and vital signs will be measured. No intervention will be performed other than the routine wound care procedure carried out in the intensive care unit. Wound assessments will be performed, and photographs will be taken on Day 1, Day 4, Day 7, and Day 14, in the same manner as in the intervention group.

Evaluation of Pressure Injury Risks in Hemofiltration

Purpose: Patients treated in intensive care units are at high risk of developing pressure injuries due to their critical illnesses as well as many risk factors such as immobility, changes in level of consciousness, hemodynamic instability, mechanical ventilation, sedative and vasoactive drug use, nutritional deficiencies and long-term hospitalization. In patients receiving hemofiltration treatment, the long duration of treatment, exposure to medical devices, limitation of movement and the severity of the clinical condition may further increase this risk. Pressure injuries can negatively affect the patient's quality of life, increase the duration of care and health care costs, and lead to significant complications. Therefore, it is important to determine the risks of pressure injuries in intensive care patients receiving hemofiltration at an early stage and to reveal risk-related factors. The aim of this study is to evaluate the risks of pressure injury in patients receiving hemofiltration therapy in the intensive care unit and to determine the clinical and treatment-specific factors associated with the development of pressure injury. Method: The research was planned as descriptive. The study will be carried out between 15 July 2025 and 1 July 2026 by Prof. Dr. It is planned to be carried out in Süleyman Yalçın City Hospital Anesthesia and Reanimation Intensive Care Unit. The population of the research will consist of patients who will receive hemofiltration treatment in the intensive care unit between the specified dates. The sample size was calculated based on logistic regression analysis using the G\*Power 3.1 program; It was determined that a minimum of 109 participants should be reached, taking into account the 5% significance level, over 95% statistical power and OR = 2.5 effect size. Patients who are 18 years of age or older, receive hemofiltration, and are approved to participate in the research by their legal representatives will be included in the study. Patients whose planned intensive care unit stay is less than 48 hours and whose skin integrity is impaired due to special treatments other than hemofiltration will be excluded from the study. Data will be collected using the Intensive Care Clinical Observation and Patient Information Form created by the researchers, as well as the Glasgow Coma Scale (GCS), Richmond Agitation-Sedation Scale (RASS), APACHE II, Braden Pressure Sore Risk Assessment Scale and Medical Device-Dependent Pressure Sore Risk Assessment Scale. Clinical characteristics of the patients, such as age, gender, height, weight, body mass index, diagnosis and reason for hospitalization, length of stay in the intensive care unit, smoking history, mechanical ventilation status and parameters, diet, frequency of positioning, medications used and paralytic agents will be recorded. In addition, daily blood gas measurements and albumin, hemoglobin, CRP and other relevant laboratory values will be evaluated. Patients' clinical and treatment-related data will be recorded on the first day, last day of hemofiltration and 72 hours after leaving treatment. Skin integrity and pressure injury development will be evaluated on the first day, last day of hemofiltration and 72 hours after leaving treatment, taking into account EPUAP and NPIAP guidelines. The presence, location, size, stage, infection status and clinical symptoms of the pressure injury will be recorded. General risk of pressure injury by Braden Scale; With the Medical Device-related Pressure Sore Risk Assessment Scale, the risk of pressure injury due to medical devices will be evaluated. Thus, the relationship of variables such as hemofiltration duration, level of consciousness and sedation, disease severity, medical device exposure, positioning frequency, nutritional status and blood parameters with the risk of pressure injury will be examined. Evaluation of Data: Research data will be analyzed using SPSS 22.0 package program. Descriptive data will be presented as numbers, percentages, mean and standard deviation. Chi-Square and Fisher exact tests will be used to compare categorical variables in independent groups. Logistic regression analysis will be performed to determine the independent factors affecting the development of pressure injury. Statistical significance level will be accepted as p\<0.05. Conclusion: The findings from this study are expected to contribute to the identification of important risk factors for pressure injuries in intensive care patients receiving hemofiltration, the early identification of high-risk patients, and the development of risk-based approaches to prevent pressure injuries in nursing care. It is also thought that the study will contribute to intensive care nursing practices and improving patient safety in terms of evaluating the risk of pressure injury due to medical devices.

Urinary Bladder Matrix (UBM) Registry

The purpose of this registry is to collect real-world information on patients treated with Urinary Bladder Matrix (UBM) products. The study will evaluate patient characteristics, treatment patterns, and clinical outcomes to better understand how UBM products are used in routine clinical practice and the outcomes experienced by patients over time.

Evaluation of the Safety and Efficacy of Dehydrated Human Placenta Tissue (dHPT) for Wound Healing

The retrospective trial is observational, intended to stand alone, complement and integrate data collected in ongoing clinical studies to aid in establishing payor coverage in the United States (U.S.) for Cellution Biologics allograft products with real-world evidence to support the clinical adoption in patients to manage chronic or surgical wounds.

Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears

This post-market clinical follow-up investigation is designed to evaluate the performance and safety of Mepilex® Up when used for the management of exuding ulcers and skin tears on the leg and foot. Approximately 70 adult participants will be treated with Mepilex® Up and followed for up to 6 weeks to assess wound progression and safety.

Effectiveness and Costs of Pressure Ulcer Treatment and the Quality of Life of Patients With Pressure Ulcers Receiving Home-Based and Institutional Care

A study aimed at comparing the effectiveness of treatment, costs, and quality of life of patients with pressure ulcers in home care and institutional care. Eighty individuals aged 60-90 years with stage II-IV pressure ulcers can participate in the study. Participants will be assessed for factors such as health status, independence, mood, and quality of life. The study will allow for better tailoring care to patients' needs. Other benefits of participating in the study is that the participants will receive a detailed assessment of their health, nutrition, quality of life, as well as support in managing their pressure ulcers. They will receive regular care and medical evaluations, which may positively impact their health and well-being. Refusing to participate in this study will not affect the patients treatment in any way. Please ask if there is anything that is unclear or if you would like additional information. Taking part in this study is entirely voluntary.

Effect of a Risk-Based Perioperative Pressure Injury Prevention Bundle in Elective Surgery Patients

This study evaluates whether a risk-based perioperative pressure injury prevention bundle reduces the development of pressure injuries in patients undergoing elective surgery lasting 3 hours or longer. Pressure injuries that develop during and after surgery are a common patient safety problem, especially in older adults and in longer procedures. In this randomized controlled trial, patients will be assigned by chance to either an intervention group or a control group. In the intervention group, each patient's pressure injury risk will be assessed before surgery using the Braden Scale together with additional perioperative risk factors, and patients will then receive one of three prevention bundles matched to their risk level (low, moderate, or high). The high-risk bundle includes prophylactic silicone foam dressings on the sacrum and heels, targeted positioning, and pressure-redistributing support surfaces. The control group will receive standard perioperative care without risk-based bundling, although Braden Scale assessment will still be performed. Skin assessments will be conducted at four time points: before surgery, in the post-anesthesia care unit, at 2-4 hours after surgery, and at 24 hours after surgery. The main outcome is whether patients develop early signs of pressure injury, including non-blanchable erythema, within the first 24 postoperative hours. The study hypothesizes that patients receiving the risk-based prevention bundle will have a lower incidence of postoperative pressure injury and non-blanchable erythema compared with patients receiving standard care.

The Effect of Pulse Oximeter Probe Replacement Interval on Pressure Injury Development in Intensive Care Patients

Patients admitted to intensive care units (ICUs) are at increased risk of medical device-related pressure injuries (MDRPIs) due to the prolonged use of monitoring devices. Pulse oximeter probes are routinely used for continuous monitoring of oxygen saturation and pulse rate and may contribute to pressure injury development when left in the same position for extended periods . Current international guidelines recommend regular assessment of the skin and repositioning of medical devices but do not specify an optimal repositioning interval. This randomized controlled trial aims to evaluate the effect of different pulse oximeter probe replacement intervals on the development of pressure injuries in adult ICU patients. The findings are expected to provide evidence to guide clinical practice and improve the prevention of medical device-related pressure injuries.

Study Title: A Multicenter, Prospective, Modified Platform Trial 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.

A multicenter prospective modified platform trial evaluating several cellular, acellular, and matrix like products and standard of care versus matched standard of care controls in the management of nonhealing pressure ulcers.

PAW-Hydrogel for Chronic Wound Healing

The goal of this randomized controlled trial is to evaluate the efficacy and safety of a novel hydrogel made of Carbopol® 940 functionalized with Plasma-Activated Water (PAW) in patients with chronic wounds (diabetic foot ulcers, pressure injuries, dehiscent wounds, arterial and venous ulcers). The main questions it aims to answer are: * Does PAW-hydrogel accelerate wound closure (reduction in surface area) compared to standard advanced wound care? * Does PAW-hydrogel reduce bacterial load in the wound bed? * Is PAW-hydrogel safe and well-tolerated (local adverse events, pain)? Participants will be randomly assigned to one of two groups: * Experimental group: Topical application of PAW-hydrogel (Carbopol® 940 neutralized to pH 5.5, loaded with reactive oxygen and nitrogen species from plasma activation) 2-3 times per week. * Control group: Standard advanced wound care (cleaning, debridement, conventional dressings). Wound area (planimetry), bacterial load (semi-quantitative cultures), pain (Visual Analog Scale), tissue quality (Bates-Jensen scale), and adverse events will be assessed over a 12-week follow-up period.

Laser Photobiomodulation for Hard-to-heal Ulcers in Frail Older Adults

The aim of this quasi-experimental prospective study is to evaluate the effectiveness of photobiomodulation treatment on hard-to-heal ulcers of various diagnosed aetiologies in frail older adults, admitted to municipal home healthcare. The study also include evaluation of cost-effectiveness, and healthcare providers experiences of treating frail older adults hard-to-heal ulcers with photobiomodulation treatment in home healthcare.

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.

Evidence-Based Nursing to Reduce Adverse Events Regarding Ventilator Associated Pneumonia, Pressure Injuries and Central Line Bloodstream Infection in Intensive Care Unit in Bangladesh

Quality of care is crucial for preventing adverse events such as infection in the intensive care units (ICUs). The most common ICU-acquired infections include pneumonia such as Ventilator Associated Pneumonia (VAP), Pressure Ulcer (PU), Medical Device Related Pressure Ulcer (MDRPU), and Central Line-Associated Bloodstream Infection (CLABSI). VAP, PU, and MDRPU are significant indicators of the quality of care, while CLABSI is a critical marker of healthcare quality in ICUs, as it is largely preventable through strict adherence to infection control protocols. VAP is a lung infection that occurs in patients receiving mechanical ventilation for more than 48 hours. A PU is defined as localized damage to the skin or underlying tissue caused solely by pressure, while MDRPUs may also result from friction or pressure from medical devices or other objects. CLABSI is a severe infection caused by improperly inserted or maintained central venous catheters, which underscores the need for stringent catheter management protocols.

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.

Evaluation of Cold Plasma in Chronic Wound Healing

The goal of this clinical trial is to evaluate the effectiveness of cold atmospheric plasma treatment in promoting the healing of chronic wounds in adult participants suffering from chronic wounds. The main questions is the following: Does the application of cold atmospheric plasma accelerate wound healing compared to standard wound care alone? Researchers will compare standard of care plus plasma treatment with standard of care alone to see if the plasma-treated group shows faster wound healing. Participants will: * Receive either standard wound care alone or standard wound care combined with cold atmospheric plasma treatment, depending on randomization. * Attend scheduled hospital visits for wound care, treatment administration, and clinical assessments, including wound photography and quality of life questionnaires. * Be followed up at home by nurses for wound care, treatment administration and clinical assessment too. * Complete a wound-related quality of life questionnaire at baseline, at week 6, and at the end of the study.