Clinical Research Directory

Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging

The goal of this pilot clinical study is to evaluate the feasibility of collecting Spatial Frequency Domain Imaging (SFDI) data in patients with circulatory compromise due to thermal burns using the FDA-cleared Clarifi Imaging System and the next generation handheld m-Clarifi. Accurate assessment of burn depth and assessment at the point of care is an essential input for clinicians to plan proper treatment and management. SFDI has been shown to be a promising method to evaluate burn depth and extent within 24 hours in pre-clinical studies. The two feasibility goals of this study are as follows: 1) Do the values obtained with a commercial SFDI system provide utility in assessing burn depth in a clinical setting? And 2) Do Clarifi and m-Clarifi provide equivalent data when assessing subjects with burn injuries (biomarker imaging values, clinical workflow).

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.

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.

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.

Tissue Quality of Integra vs. BTM Treated Burns

An observational analysis of Integra-treated burns and Novosorb Biodegradable Temporizing Matrix (BTM)-treated burns will be undertaken 12-36 months post final skin graft application by retrospectively analyzing the patient's electronic medical record, and prospectively using a non-invasive measures of tissue quality and patient-reported outcomes. Patients will be offered the option to consent for a tissue biopsy for pathological evaluation.

IEEM- Work:Rest Cycles in Burn Survivors- Humidity

The purpose of this project is to identify the effects of a severe burn injuries in humans on core temperature responses during work:rest cycles while in a heated environment.

Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) Trial

The Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) trial will be a 5-year (3-year enrollment), open label, phase-3, multi-center, early in-hospital phase randomized trial utilizing burn centers from within the LITES network and will enroll approximately 750 injured adult patients who have suffered large 2nd or 3rd degree thermal burns on at least 20% of their body surface requiring burn resuscitation. The objective is to determine if initiating plasma resuscitation as soon as possible upon arrival to an emergency department or burn unit is the most effective resuscitation for those who have experienced large thermal burns and significantly reduces the morbidity and mortality attributable to post-injury complications as compared to standard in-hospital resuscitation practice.

SN514-066b Enzyme in Deep Partial Thickness Burns

This study will examine the tolerability of a gel formulation of the enzyme SN514 in patients with burns suitable for enzymatic debridement. In a rising dose fashion by sequential cohort, concentrations of 0.1%, 0.2%, 0.4% and 0.8% will be tested. Groups of 3 will undergo daily debridement for up to 7 days. Extent of debridement and adverse signs and symptoms will be recorded daily. Dose escalation will stop if a dose level is found to be intolerable. Dose escalation may accelerate if a tested dose is entirely ineffective. There is no placebo control as all burn wounds require debridement.

Reduction of Opioid Dose Using Conditioning & Open-Label Placebo (COLP) in Intensive Rehabilitation

The use of conditioning open-label placebo (COLP) 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 dose to diminish adverse effects as well as the risk of addiction associated with narcotic treatment.

Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns

There is currently no standard treatment to prevent burn depth conversion in partial-thickness burns. Conversion into deeper wounds is associated with higher complications and morbidity. The most common theory attributes this depth conversion to the prolonged inflammatory response that occurs after burn injury. Therefore, the investigators propose testing the safety and efficacy of tacrolimus ointment (an immunosuppressive agent) in patients with deep partial-thickness burns.

Burn Mortality Prediction Scores

This retrospective observational cohort study evaluates hospitalized burn admissions treated at the Burn Center of Gaziantep City Hospital between October 2023 and February 2026. The study aims to compare the ability of three burn severity scoring systems, the Abbreviated Burn Severity Index (ABSI), Revised Baux score, and modified Ryan score, to predict in-hospital mortality. Electronic medical records were reviewed for demographic characteristics, burn-related variables, inhalation injury, burn depth, intensive care admission, mechanical ventilation, sepsis, surgical procedures, length of hospital stay, and survival status at hospital discharge. The primary outcome is in-hospital mortality. The predictive performance of the scoring systems will be evaluated using receiver operating characteristic analysis and logistic regression.

Non-Invasive Vagus Nerve Stimulation in Burn Patients During Dressing

This study will evaluate the effects of non-invasive vagus nerve stimulation on pain, anxiety, and quality of life in burn patients during the dressing process. Participants will be randomly assigned to one of three groups. One group will receive non-invasive vagus nerve stimulation for 20 minutes before dressing, one group will receive non-invasive vagus nerve stimulation for 20 minutes during dressing, and the control group will receive standard dressing care only. Pain will be assessed using the Visual Analog Scale, anxiety will be assessed using the Beck Anxiety Inventory, and quality of life will be assessed using the SF-12 Health Survey. The study aims to determine whether non-invasive vagus nerve stimulation can reduce dressing-related pain and anxiety and improve quality of life in burn patients.

Effects of Non-Invasive Vagus Nerve Stimulation in Adolescent Burn Patients

This study will evaluate the effects of non-invasive vagus nerve stimulation in adolescents aged 12 to 18 years who have burn injuries. The study will include patients who have completed the acute phase after burn injury and who have symptoms such as anxiety, sleep problems, pain, or itching. Participants will be randomly assigned to one of two groups. One group will receive conventional physiotherapy together with non-invasive vagus nerve stimulation. The other group will receive only conventional physiotherapy. The treatment program will be applied 5 days per week for a total of 10 sessions. The study will assess whether non-invasive vagus nerve stimulation improves anxiety, sleep quality, pain, itching, and autonomic nervous system function. These outcomes will be measured before and after the treatment program using clinical scales and heart rate variability measurements.

Effect of Pulmonary Rehabilitation on Respiratory Parameters in Upper Extremity Burns

This study will evaluate the effects of a pulmonary rehabilitation program on breathing function, respiratory muscle activity, respiratory muscle thickness, and functional capacity in adults with upper extremity burns. Participants will be randomly assigned to either a pulmonary rehabilitation group or a control group. The pulmonary rehabilitation group will receive respiratory muscle training together with upper extremity aerobic exercises, while the control group will receive a conventional exercise program. Assessments will be performed before the intervention, at week 3, and after the 6-week intervention period. The results may help improve rehabilitation approaches for people with upper extremity burns.

Effect of Non-Invasive Vagus Nerve Stimulation in Burn Patients

This study will evaluate the effects of non-invasive vagus nerve stimulation (nVNS) in adults with burn injuries. Burn patients may experience anxiety, poor sleep quality, pain, itching, and changes in autonomic nervous system function during recovery. Participants will be randomly assigned to one of two groups. The intervention group will receive conventional physiotherapy plus nVNS, and the control group will receive conventional physiotherapy only. Both groups will receive treatment 5 days per week for a total of 10 sessions. nVNS will be applied through electrodes placed on the external ear for 20 minutes per session. Anxiety, sleep quality, pain, itching, and autonomic function will be assessed before and after the treatment period. Autonomic function will be evaluated using heart rate variability measurements. The results will help determine whether nVNS may be a useful supportive method in the rehabilitation of burn patients.

Foreign-National Burn Patients in a Border-Region Burn Center

This retrospective cohort study will evaluate burn patients hospitalized and treated at the Burn Center of Gaziantep City Hospital between October 2023 and June 2026. The study aims to compare demographic characteristics, burn severity, clinical course, and in-hospital outcomes between Turkish citizens and foreign-national burn patients. Data will be obtained retrospectively from patient files, discharge summaries, intensive care records, operative notes, and the hospital information management system. Variables will include age, sex, nationality status, burn etiology, total body surface area burned, inhalation injury, sepsis, intensive care unit admission, mechanical ventilation requirement, surgical treatment requirement, number of operations, length of hospital stay, discharge status, transfer to another center, and in-hospital mortality. No additional intervention, diagnostic test, treatment, or follow-up procedure will be performed as part of this study. All analyses will be conducted using anonymized or coded retrospective clinical data.

Cardiovascular Responses in Burn Survivors During Exercise

This project will identify the efficacy of cooling modalities aimed to attenuate excessive elevations in skin and internal body temperatures, and associated indices of cardiovascular stress, during physical activity in well-healed burn survivors. The investigators will conduct a randomized crossover design study. Non-burned control subjects and subjects who experienced burns covering 20% or more of their body surface area will be investigated. Subjects will exercise in heated environmental conditions while receiving no cooling (control) as well as skin wetting.

Mitochondrial Energy Metabolism in Burns

The goal of this observational study is to assess the impact of burn injury on cellular energetics in patients that have been admitted to the burn center at Arkansas Children's Hospital for burn care and require one or more procedures to clean, debride, and repair burn wounds will be eligible to participate in this study. During the study, we will collect the following information: * General background information such as date of birth, height, weight, and other basic information. * Medical information, such as: basic medical information, details of burn injury, vital signs on the day of surgery, medicines you take during your stay, and some clinical tests. * Blood, urine, and tissue during surgeries you have during your stay.

The Effect of Simulated Burn Injury on Post Exercise Recovery in Hot Environments

Burn survivors have difficulty thermoregulating due to reduced skin blood flow and sweating responses at the grafted sites. It has been previously shown that this impaired heat dissipation results in burn survivors experiencing higher core temperatures for a given exercise/environmental exposure compared to non-burned individuals. This also holds true with the use of simulated burn injury. When an absorbent material is applied to the skin over a desired amount of body surface area, it replicates a burn injury of the same size (i.e., simulated burn injury). A question that remains unknown is if this impaired thermoregulation in burn survivors would affect post-exercise core temperature recovery, i.e., do burn survivors recover slower than non-burned individuals upon stopping exercise. To that end, the primary objective of this project is to determine the rate at which body temperature and other markers of thermoregulation recover after a bout of exercise in the heat and if this response is different in the same individual with and without simulated burn injury.

STAT: Standard Therapy Plus Active Therapy

The objective of the study is to assess the efficacy of STAT, an activity-based therapy protocol compared to standard therapy (ST) to improve functional outcome and reduce disability in patients recovering from burn injury. This randomized multi-center trial is designed with two parallel treatment groups: STAT and ST. Efficacy of the STAT protocol will be determined through comparison to the ST only group. It will be conducted at seven burn centers.

The Acute Burn ResUscitation Multicenter Prospective Trial

This is a prospective randomized multi-center study which will compare acute fluid resuscitation using a colloid strategy (LR + 5% Albumin) to a crystalloid strategy (LR alone), in adults with an acute burn involving at least 25% of their total body surface area.

Fatigue After Burn

The goal of this observational, prospective cohort study is to learn more about fatigue after burn injury and how it associates with daily activities, health-related quality of life, and return to work. The study is based on data from adult patients who come for follow-up at the Burn Centre's outpatient clinic at Uppsala university hospital 6- and 12 months post-burn. Patients who come for follow-up are routinely asked to fill out several questionnaires to detect any problems that might have occurred due to the burn injury. Apart from ordinary assessments the study participants were asked to fill out three additional questionnaires. Data from questionnaires together with patient characteristics will be analysed and compiled and presented in a scientific article.

Plyometrics for Strength and Function After Pediatric Burns

Pediatric burn survivors may experience persistent deficits in lower-limb strength, explosive power, and functional performance after hospital discharge. This randomized controlled trial evaluated whether a 12-week supervised plyometric training program improves lower-extremity muscle strength, power, and functional capacity compared with a standard exercise program in children and adolescents with severe burn injuries.

Mesenchymal Stem Cells in the Treatment of Burn Wounds

Burn patients were randomly divided into the low-dose stem cell gel group, the high-dose stem cell gel group, and the placebo group (with only the gel), and received the same treatment under the same conditions simultaneously.