Clinical Research Directory

Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients

Sepsis is a major and life-threatening complication in patients with severe burn injuries, frequently progressing to sepsis-induced coagulopathy (SIC) and disseminated intravascular coagulation (DIC). Early detection of coagulopathy in burn patients remains challenging due to the massive background inflammatory response triggered by the thermal injury itself. The primary objective of this prospective observational study is to evaluate the diagnostic performance and early kinetic trajectory (from Day 0 to Day 10) of the revised Japanese Association for Acute Medicine (JAAM-2) score for detecting sepsis-induced coagulopathy in severe burn patients. Adult patients with severe thermal burns (\>20% total body surface area) who develop a first episode of sepsis in the intensive care unit (ICU) will be monitored over a 28-day period. Sequential clinical evaluations and laboratory tests will be performed at Day 0 (T0), H48 (Day 2), Day 4, Day 6, Day 8, and Day 10. The study will compare the JAAM-2 score with established coagulopathy scores (ISTH Overt DIC and ISTH-SIC) and analyze its association with organ dysfunction, sepsis control at Day 7, and 28-day overall mortality.

Efferon LPS Hemoadsorption in in Patients With Thermal Burns

The aim of the study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoadsorption using the Efferon® LPS device to reduce the severity of clinical symptoms and to prevent the progression of multiple organ dysfunction or to arrest its development in patients with burn disease with an RFI score ≥71 and ≤181. Patients will be randomized in two groups: control group receiving baseline therapy (including CRRT) and treatment group receiving baseline therapy and Efferon® LPS hemoadsorption in combination with CRRT.

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

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.

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.

Deepview HHF Training and Validation Study

The purpose of this Study is to help expand the use of the DeepView AI System so that it can assess burn injuries on the hands, head/face, and feet. To do this, the Study will collect new images of burns in these areas. Some of these images will be used to improve and retrain the AI system, while others will be used to test how well the updated system performs. The images for both purposes will be collected at the same time. The new images from the hands, head/face, and feet will then be combined with existing images from other body areas. This will allow researchers to determine whether the updated AI system performs as well as, or better than, previous versions of the technology. For participants with Study Burns requiring surgical excision, the Study site clinician will collect punch biopsies from the Study Burn according to a standardised burn wound punch biopsy collection.

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.

Resistance, Plyometric, and Combined Exercise Training in Children With Severe Burns

Children who experience severe burns may continue to have reduced muscle strength, power, balance, and physical function after their wounds have healed. Exercise is an important part of burn rehabilitation, but it is unclear which type of training provides the greatest improvement. This randomized study compared three exercise programs in children aged 10 to 17 years with burns affecting more than 30% of their total body surface area. Participants were assigned to traditional resistance training, plyometric training, or a program combining both approaches. Each group completed supervised exercise sessions three times per week for 8 weeks. Muscle strength, upper- and lower-body power, dynamic balance, and upper-limb stability were measured before and after the training period. The study aimed to determine which exercise approach was most effective for improving neuromuscular and functional performance during long-term pediatric burn rehabilitation.

Response of Muscle Mechanical Properties to Early Multi-angles Isometric Exercises in Acute Burn Patients

This study will be conducted to investigate the effect of early multi-angle isometric exercise on muscle properties in post-burn patients.

Reallocating Rehabilitation Time to Wii Fit or Pilates After Lower-Limb Burn Injury

This randomized controlled trial will evaluate whether reallocating part of a fixed-duration supervised rehabilitation session to Wii Fit or Pilates will improve functional outcomes in adults with healed lower-extremity burns. Participants will be randomly assigned to Wii Fit, Pilates, or conventional rehabilitation and will receive 60-minute supervised sessions three times weekly for 12 weeks. Walking capacity, postural stability, functional mobility, and quadriceps muscle performance will be assessed at baseline, after the 12-week intervention, and 12 weeks after completion of supervised rehabilitation. The study will compare these time-matched rehabilitation approaches and will assess the persistence of functional changes during the subsequent follow-up period.

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.

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).

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.

A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds

This is a prospective, randomized, controlled, multi-center clinical study comparing SupraSDRM® to standard of care wound dressing, BTM, in the treatment of full-thickness wounds deemed not immediately suitable for definitive grafting will be performed.

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.

Manual Implantation of Full-Thickness Skin Microcolumns

The objective of this study is to validate the proof of concept regarding the approach of manual implantation of full-thickness skin microcolumns (FTSMs) as coverage for open wounds without creating an additional donor scar and while also capitalizing on the wound healing benefits offered by full-thickness skin grafts.

Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds

The purpose of this study is to determine the effect to which Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany) can reduce the need for grafting compared to Standard of Care (SoC). Furthermore, the study intends to evaluate if Suprathel® allows for a reduction of reduction of pain, infection, provider workload, scar development and costs compared to SoC.

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

This multicentre phase III clinical trial will target adults and adolescents of 12 years and older with severe burns to confirm the efficacy and functionality of denovoSkin™ in achieving wound closure and reducing scarring in patients with deep partial and full-thickness burns as compared to split-thickness skin.

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.

Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children

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

SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma

This clinical trial is designed to assess the safety, effectiveness and benefits of Self Assembled Skin Substitute SASS grafts as a permanent skin replacement for the treatment of full-thickness burn wounds that require permanent coverage where the availability of donor sites is limited.

Effects of the Mobile Application Developed for Families After the Earthquake on First Aid Knowledge and Burn Prevention

The aim of this project was to determine the effect of the burn prevention and first aid mobile application developed for families living in tent cities and container houses after the earthquake on the burn prevention and first aid knowledge of families and the development of burns in the first two months after the mobile application. The research was planned as a prospective, two-arm (1:1), randomized controlled trial. The study population will consist of families living in tent cities and container houses in Şanlıurfa. As a result of the power analysis performed in the G\*Power program, the sample group will consist of 30 families from the tent city and 30 families from the container city, taking into account the losses with a power of 90% and a maximum bidirectional 5% type error. All of the families (30 mobile application-study group; 30 control group) who make up the sample of the research will be given a training (powerpoint presentation) prepared by the researcher in line with the literature, and burn prevention and first aid practices will be explained and their questions will be answered. Then, the training to be given with the mobile application will be downloaded to the phones of the families in the experimental group and the training will continue through the application. In the study, data will be collected with the "Descriptive Characteristics Form", "Information Form on Burn Prevention and First Aid" and "Burn Development Follow-up Form", which include the descriptive information of the families. The data obtained from the study will be analyzed in computer environment.

Integrated Case Management for Burns Care in Pakistan

To test whether a culturally adapted multicomponent intervention for improving burns care and patient/family rehabilitation is effective in improving survival among burn victims in Pakistan and is cost-effective. The comparator will be usual care plus brief written self-help advice (enhanced usual care). The study is designed as a multicentre, pragmatic, parallel group, individually randomised trial. Participants in the intervention arm will receive 8 sessions delivered by the case managers (6 low-intensity sessions lasting 30-60 minutes in the hospital/community and 2 follow-up sessions lasting 30 minutes in the community). Assessments will be conducted at baseline, at 3 months, 6 months and at 12-months post-intervention.

Virtual Reality for Pain and Fear in Children With Burns

Burn injuries are very painful for children, especially during dressing changes when the wound is cleaned and re-bandaged. This procedure, while necessary, can cause pain, fear, and distress that may make children afraid of future treatments. Virtual reality (VR) is a technology that uses a headset to show an immersive, interactive 3D world. It can distract children from painful medical procedures. This study aims to find out if using VR during burn dressing changes can reduce pain, fear, and behavioral distress in children aged 6 to 12 years. Half of the children will receive standard burn care plus VR distraction during their dressing change. The other half will receive standard care only. The study will take place at the Burns and Plastic Surgery Center, Mansoura University, Egypt. Children will be recruited from both inpatient wards and outpatient clinics. Pain will be measured using a number scale, fear using a faces scale, and distress will be observed throughout the procedure. It is expected that children who use VR will report less pain, show less fear, and display less distress during their dressing changes compared to children who receive standard care alone.