Clinical Research Directory

Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection

Burn wound infections remain a major source of morbidity in patients with thermal injuries and contribute to delayed healing, graft loss, and prolonged hospitalization. The emergence of antimicrobial-resistant organisms further complicates management and highlights the need for non-antibiotic antimicrobial strategies. Photodynamic therapy (PDT) is an antimicrobial approach that combines a photosensitizing agent with visible light to generate reactive oxygen species capable of killing bacteria. This randomized clinical trial will evaluate the safety and preliminary efficacy of methylene blue-mediated photodynamic therapy for the treatment of burn wound bacterial contamination. Participants receiving standard burn care will be randomized to receive either methylene blue-photodynamic therapy with blue light illumination or light therapy alone during routine dressing changes. Treatments will occur during two consecutive dressing changes. The primary objective is to determine whether methylene blue photodynamic therapy reduces bacterial burden in burn wounds compared with light therapy alone. Secondary outcomes include safety, tolerability, and effects on wound healing.

Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns

To compare MW-III to Silvadene® Cream 1% (Silver Sulfadiazine) with respect to "time to healing" (≥95% re-epithelialization) of a partial thickness target thermal burn.

Reducing Pain and Anxiety During Dressing Changes After Burn Surgery Using Virtual Reality

Burn injury and its treatment is an intensely painful experience. Most severely injured patients require numerous dressing changes and skin grafting procedures (removing skin from healthy part of the body and moving it to damaged area of the body). This procedure cause extensive pain and anxiety and many patients can become dependent on pain killers during their hospital stay and throughout rehabilitation. This can delay reintegration into society and increase the chance of opioid dependence. An effective pain management plan plays a large role in patient recovery. In addition to the physical pain experienced by these patients, burn injury is an intensely stressful and emotional life experience. This study will use a non-drug approach to reduce pain and extensive use of pain killers (opioids) during dressing changes. In particular, the study will use an immersive (allows to experience computer-generated environment as a real world) Virtual reality (VR) distraction tool during dressing change after skin graft surgery. Individuals who will decide to participate in this study will be asked to wear headgear to view immersive 360 videos specially designed by the study team. Before and after this exposure participants will be asked to complete a measurement of their anxiety level (VAS) and rate their pain. This study will help to determine if using VR as a distraction tool during painful dressing changes will reduce pain and anxiety, and therefore opioid medications requirements, and will rely on participants experience and adapt VR videos according to participants' response.

Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults

This is a prospective, observational, monocentric, phase II (exploratory) cohort study aiming to describe the evolutionary profile of the initial volume of glucose distribution (IDVG) during the first four days of management of severely burned patient.

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.

Impact of a Telerehabilitation Program With Technology Enhancement on Post-burn Recovery

The purpose of this study is to examine the effect of participating in a tele-rehabilitation program after a burn.

4-Aminopyridine to Treat Skin Burns

Many patients suffer from traumatic burns and current treatments do not increase the regenerative potential of either skin grafts or the remaining uninjured skin. There is a need to develop treatments to accelerate and improve healing of burn injuries. More research is needed to evaluate the role of 4-AP, a promising new agent with an excellent safety profile, on wound and burn healing. The investigational treatment will be used to test the hypothesis that 4-AP accelerates burn healing in traumatically burned patients.

A Study Protocol for the Implementation and Evaluation of a Self-management Support Program in Burns Aftercare for Burn Survivors in the Netherlands

This study aims to evaluate a new self-management support intervention for burn survivors called BreeZe. The overall goal of BreeZe is to enhance burn survivors' self-management skills in order to integrate treatment and life goals and subsequently optimize burn survivors' quality of life and health-related outcomes. The BreeZe intervention is based on the content of the ZENN intervention, an evidence-based self-management support intervention for transplant recipient patients, which we adapted to the context of burn care. The BreeZe intervention is based on the theoretical framework of the Self-Regulation Theory. The main intervention strategies are based on evidence-based techniques, namely goal setting and pursuit, Solution-Focused Brief-Therapy, and Motivational Interviewing. In practice, this means that the intervention focuses on a positive approach in order to enhance burn survivors' intrinsic motivation and self-efficacy to encourage sustainable behaviour change regarding self-management in burns aftercare. To achieve this, we will implement BreeZe using various implementation strategies. These will include educating healthcare professionals on self-management, training them in communication skills (e.g. motivational interviewing), and providing supportive materials such as a decision aid tool (i.e., self-management web) and a workbook tailored for burn survivors. This multicenter stepped-wedge hybrid type 2 effectiveness-implementation study aims to evaluate BreeZe's effectiveness, and to evaluate the effects of our implementation approach. The study includes a pre-implementation phase (usual care), implementation phase, and a post-implementation phase (with BreeZe), and involves the three designated burn centers in the Netherlands. The phases will be rolled out sequentially from April 2024 to November 2024, and enrollment of participants concludes in July 2025. For evaluation, this study uses the RE-AIM evaluation framework, focusing on Reach, Effectiveness, Adoption, Implementation, and Maintenance. Our co-primary outcomes are 1) BreeZe's effectiveness in improving self-management skills in burn survivors, and 2) the effects of our implementation approach on the implementation outcomes Reach, Adoption, Implementation and Maintenance. Secondary effectiveness outcomes are self-regulation, participation, dependency, and patient-centeredness for burn survivors, and self-management support skills for healthcare professionals. Data collection for burn survivors occurs at 2 weeks, 6 months, and 12 months post-discharge, using questionnaires. Data collection for healthcare professionals occurs pre-implementation, and 3, 6 and 12 months after implementation, using questionnaires, interviews, and video observations.

Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns

This is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using NovoSorb® Biodegradable Temporizing Matrix (BTM).

Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Thermal Burns

This observational pilot study aims to establish criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS device in adult patients with burn injury. Participants will be prospectively enrolled into the treatment group and compared with a retrospectively selected control group. Each patient in the treatment group will undergo two hemoadsorption sessions, each lasting 6-12 hours, with a 24 hours interval between sessions. The procedures may be performed in combination with hemofiltration or hemodiafiltration at the investigator's discretion.

The Effect of Cartoon Character-Printed Band Use During Burn Dressing on Fear, Stress, Pain, and Physiological Parameters in Children: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effect of using cartoon character-printed medical bands during burn dressing procedures on children's fear, stress, pain, and physiological parameters. Burn dressing is often a distressing and painful procedure for pediatric patients, which may lead to increased anxiety, physiological instability, and negative treatment experiences. In this study, child-friendly cartoon-printed adhesive bands are used as a non-pharmacological intervention to provide distraction and emotional comfort during burn dressing. By incorporating familiar and visually engaging designs, the intervention seeks to reduce children's perception of pain, alleviate stress, and improve physiological stability (heart rate, oxygen saturation, and respiratory rate) during the procedure. Participants will include children aged 7-11 years receiving burn care in a pediatric burn unit. They will be randomly assigned to either the intervention group (cartoon-printed band use) or the control group (standard plain band use). Fear, pain, and stress will be assessed using validated scales before, during, and after the dressing procedure. Physiological parameters will be measured using a pulse oximeter. The study is expected to contribute to the development of child-centered, non-pharmacological methods that make medical procedures less stressful and more tolerable for pediatric patients. Results may guide the design of more comforting and engaging treatment environments in pediatric burn care.

The Effect of Mobile Robot Assisted Gait Training on Gait Performance in Chronic Patients With Impaired Gait Function After Burn Injury

This study aims to examine the clinical effectiveness of gait training using wearable robots in patients with impaired gait function after burn injury. The participants were chronic patients who underwent split-thickness skin grafting or burns of more than 50% of the lower extremities and still had impaired gait dysfunction 6 months later. Eligible participants were aged over 18 years and had a Functional Ambulation Category (FAC) score of 3 or higher. Physiotherapy was performed on a one to one basis by qualified physiotherapists for 1 hour per day, 5 days a week Monday through Friday, for 12 weeks. Assessments were carried out before and immediately after the 12-week training period. Physical ability were assessed using the functional ambulatory category(FAC) scale, the 6-Minute Walk Test (6MWT), and the visual analogue scale (VAS). Spatiotemporal gait parameters-including gait speed, cadence, and step length-and sagittal joint kinematic parameters for the hip, knee, and ankle during stance and swing phases were measured during gait analysis. Pulmonary function test such as forced vital capacity (FVC), 1-s forced expiratory volume (FEV1), and carbon monoxide (DLco). The highest maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) value were evaluated.

Pilot Feasibility Trial of a Peer Support Program for Trauma Survivors

Traumatic injuries from events like car crashes, falls, or fires are a leading cause of disability. Survivors often face not only physical challenges but also long-lasting pain, mental health challenges and difficulty returning to work and family life. Although medical care focuses on physical recovery, survivors frequently report that their emotional and social needs are overlooked and unmet. Peer support-guidance from people who have lived through similar injuries-can reduce distress and improve coping. However, no programs in Canada currently provide peer support to trauma survivors across their recovery journey, from hospital to rehabilitation to community living. The investigators worked with trauma survivors, caregivers, and healthcare providers to co-design a Peer Support Program (PSP) that offers support throughout these stages. This pilot study will test whether the program is feasible and acceptable, and explore its early impact on recovery. Results will guide a future larger trial to expand peer support in trauma care.

Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents

This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and adolescents with partial deep dermal and full thickness burns.

Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With Thermal Burns

This observational pilot study aims to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS NEO device in pediatric burn injury. Participants will be prospectively assigned to the treatment group and compared with a retrospectively selected control group. Each patient in the treatment group will undergo two hemoadsorption sessions, each lasting 6-12 hours, with an interval of 24-120 hours between procedures. The sessions may be performed in combination with hemofiltration or hemodiafiltration at the discretion of the investigator.

VR-PAT and fNIRS to Identify CNS Biomarkers of Pain

This study aims to use functional near-infrared spectroscopy (fNIRS) to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality (VR).

Autologous Point-of-Care Adipose Therapy: Recent Injury

The goal of this study is to explore if an adipose-based therapeutic strategy can treat full-thickness soft-tissue trauma wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are: \- Can immediate autologous adipose and autologous layered composite grafting be effective for acute functional soft-tissue reconstruction? Researchers will compare the single-stage autologous layered composite grafting method to traditional methods to see if it improves healing outcomes, minimizes scarring, and reduces infection risk. Participants will: * Receive immediate fat grafting into the wound. * Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.

Autologous Point-of-Care Adipose Therapy: Delayed Injury/Scar

The goal of this study is to explore if an adipose-based therapeutic strategy can treat contracted scars secondary to soft-tissue burn wounds in injured individuals, especially those with severe burns or soft-tissue loss. The main question it aims to answer are: \- Can autologous layered composite grafting demonstrate non-inferiority compared to full-thickness skin grafting for delayed reconstruction of post-burn or trauma scar contracture? Researchers will compare the single-stage autologous layered composite grafting method to traditional methods to see if it improves healing outcomes, minimizes scarring, and reduces infection risk. Participants will: * Receive fat grafting at time of scar revision. * Undergo simultaneous split-thickness skin grafting for full soft-tissue reconstruction.

Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation

The use of the conditioning open-label placebo (COLP) paradigm will be studied as a dose extension method to lower opioid dosage in patients with spinal cord injury, polytrauma, and burn injury. The goal is to provide the same level of pain relief with a reduced opioid intake to diminish side effects as well as the risk of addiction associated with opioid treatment.

Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft

Investigators hypothesize that topical tranexamic acid will have better or comparable efficacy to topical thrombin in reducing hematoma formation at the wound base. The purpose of the study is to demonstrate that topical tranexamic acid will be a non-inferior alternative medication to the current standard of care,THROMBIN-JMI® , and at a lower cost to the health system.

CytOSorb TreatMent Of Critically Ill PatientS Registry

Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based resource to measure and improve the quality of patient care

Comparison Between Burn Dressing Using Tilapia-Fish Skin Versus Regular Dressing

The aim of this study is to evaluate the use of tilapia fish skin as a healing dressing in burn patients and its clinical outcome and compare it with regular dressing.

Understanding the Burn Wound Microbiome: Comparing Traditional Wound Cultures to Next Generation Sequencing Technology

The purpose of this investigation is to better understand the wound microbiome in burn wounds and the role it plays in outcomes and complications related to treatment.

Presepsin Diagnostic Performance in Severe Burn Sepsis

This study enrolls approximately 270 adult patients with severe burns covering at least 20% of total body surface area to evaluate how well the blood biomarker presepsin diagnoses sepsis early in this high-risk population. Sepsis-a life-threatening condition caused by an exaggerated immune response to infection-is particularly urgent to detect promptly in burn patients. Participants will undergo blood tests for presepsin at predefined time points, and these results will be compared to C-reactive protein (CRP), procalcitonin (PCT) levels, Sepsis-3 clinical criteria, and blood culture findings. The primary goal is to measure presepsin's sensitivity and specificity for sepsis detection, thereby determining its diagnostic accuracy. Findings from this study may enable faster sepsis treatment in severe burn patients and improve clinical outcomes.