Clinical Research Directory

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 6-year (4-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 resusciation. 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.

VR-PMR for Post-Burn Symptoms

The goal of this clinical trial is to learn whether progressive muscle relaxation (PMR), delivered either alone or enhanced with virtual reality (VR), can help treat chronic symptom, such as pain, itch, anxiety, sleep disturbances, and fatigue, in adult burn survivors. The main questions it aims to answer are: * Does VR-enhanced PMR (VR-PMR) reduce chronic pain, anxiety, itch, sleep disturbances, and fatigue more effectively than standard PMR? * Is VR-PMR a feasible and acceptable self-administered home-based intervention for burn survivors? Researchers will compare two self-administered intervention conditions, VR-enhanced PMR and standard PMR, using a randomized to sequence crossover design to see if VR technology enhances the therapeutic effects of PMR on chronic symptom management in burn survivors. Participants will: * Complete home-based sessions of VR-enhanced PMR * Complete home-based sessions of standard PMR * Report symptoms such as pain, itch, anxiety, sleep disturbances, and fatigue throughout the study * Use VR equipment provided for the intervention period (during the VR-PMR arm)

TDAP in Burn Patients (Group 2)

This study is following adult patients with serious burn injuries to better understand how their bodies respond to treatment and recovery. Researchers will collect small amounts of blood and tissue samples, along with information already recorded in the medical record, such as vital signs, lab results, and details of surgeries or complications. The goal is to identify patterns that may help predict who is at higher risk for infections or other problems after a burn injury. This information could lead to new tools, including computer-based models, to improve burn care and outcomes in the future. Participation involves providing samples and allowing researchers to review medical records during the hospital stay and up to one year after discharge.

Surgical Critical Care Initiative (SC2i) Tissue and Data Acquisition Protocol (TDAP) in Burn Patients Improving the Robustness and Generalizability of Post-burn Sepsis Prediction With the Post-Burn Sepsis Digital Twin. Group 1

This study is following adult patients with serious burn injuries to better understand how their bodies respond to treatment and recovery. Researchers will collect small amounts of blood and tissue samples, along with information already recorded in the medical record, such as vital signs, lab results, and details of surgeries or complications. The goal is to identify patterns that may help predict who is at higher risk for infections or other problems after a burn injury. This information could lead to new tools, including computer-based models, to improve burn care and outcomes in the future. Participation involves providing samples and allowing researchers to review medical records during the hospital stay and up to one year after discharge.

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.

Skin Wetting in Burn Survivors

This project will identify the efficacy of whole body skin wetting aimed to attenuate excessive elevations in internal body temperatures during physical activity in well-healed burn survivors. The investigators will conduct a randomized crossover design study. Non-burned control subjects, subjects who experienced burns covering \~20% to 40% of their body surface area, and subject having burns \>40% of their body surface area will be investigated. Subjects will exercise in heated environmental conditions while receiving no cooling or whole body skin wetting.

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.

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.

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.

Biphasic Positive Airway Pressure Ventilation Versus Flow-Controlled Ventilation in Burn Patients

The goal of this clinical trial is to learn if the new ventilation mode flow-controlled ventilation (FCV) is a more protective mode of ventilation for adult patients after severe burn injury. The main question it aims to answer is: Does FCV reduce the mechanical power (a key determinant of ventilator-induced lung injury) compared to conventional pressure-controlled ventilation (PCV) during ventilation of patients with burn injury? Researchers will compare FCV with PCV for up to 70 hours of ventilation to see if the mechanical power is reduced during ventilation of participants being in need of ventilation after severe burn injury. Ventilation of participants will be controlled by either FCV or PCV. Group-specific ventilation will have the following characteristics: * FCV: Control of airway flows during inspiration and expiration, use of individualized lower and upper airway pressures and no fixed values for the volumes being inspired and expired (tidal volumes) * PCV: No control of airway flows during expiration, use of individualized lower airway pressures and upper airway pressures for a fixed tidal volume during each breath (6-8 ml/kg ideal body weight) In total, at least 24 participants in need of ventilation after severe burn injury will be ventilated either with FCV (12 participants) or PCV (12 participants) for up to 70 hours. During ventilation mechanical power is computed according to certain ventilation parameters. Additionally, we evaluate organ functions of the cardiovascular systems, the lungs and other organs during and after the group-specific ventilation.

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.

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).

Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury

The purpose of this study is to find out if IV lidocaine infusion decreases the need of opioids, improves pain management, and reduces the risks of developing complications from prolonged opioid use in burn injury participants undergoing wound debridement in the operating room. Participants will: * be randomized to receive either an IV Lidocaine treatment or an IV Saline Placebo during their surgery. The IV treatment continues for 48 hours after surgery. * be asked about their pain and how they're feeling at 4 timepoints during the 48 hours. * be asked about their pain 2 weeks after surgery. The participant and medical care providers will both be blinded to what IV treatment is being received. Researchers will compare the 2 groups to see if IV Lidocaine helps decrease the need of opioids, improves pain management, and reduces the risks of developing complications from prolonged opioid use (this includes opioid tolerance, opioid dependence, and opioid induced hyper-sensitivity to pain).

Comparison of High Flow Nasal Oxygen and Nasal Cannula in Burn Patients Under Sedation

Burn-related pain is severe and often difficult to manage. Burn patients often require high doses of opioids and anxiolytics. Anesthetic agents used during sedation such as benzodiazepines, propofol and opioids can cause respiratory depression, predisposing patients to hypoventilation and hypoxemia due to airway obstruction. Oxygen is administered to patients with a standard nasal cannula during sedation. High Flow Nasal Oxygen (HFNO) helps to improve the oxygenation of patients with respiratory distress by delivering high flow humidified oxygen through the nasal cannula at a high rate of up to 40-70 liters per minute. The aim of this study was to compare the effects of HFNO and nasal oxygen therapy in preventing hypoxemia in deeply sedated burn patients.

Smartphone Assisted Self-management Education for Adult Burn Patient At Aftercare

Burn rehabilitation management is dependent on the patients themselves, non-treatment adherence may delay the optimal timing of burn rehabilitation and it may not be regained easily. The inevitable sequelae of increasing joint stiffness and tethered soft-tissue glide become more devastating over time. It has a major impact on clinical outcomes such as scarring, deformity and dysfunction, which result in lower quality of life compared to general population There is a growing body of research on patient-centered interventions including the concept of self-management. Such phenomenon is consistent with burn patients' needs at aftercare. The proposed smartphone self-management program is to change the paradigm from paternalistic to collaborative relationship. Self-management is to build up patient equipping ability in problem solving, decision making, and appropriate use of resources and has led to improved patient engagement, adherence, and better quality of care. The investigators hypothesize that, upon intervention completion and compared with the control group, burn patients in the intervention group will report: 1. Higher level of health-related quality of life, 2. Higher level of self-efficacy 3. Higher level of score in Burn Rehabilitation Knowledge 4. Lower pain level, as measured by Numeric Pain Rating Scale; and 5. Lower level of itchiness The desired smart phone assisted self-management intervention will be carried out by principal investigator to selected adult burn patients before discharge and post discharge period. Before discharge, ward nurses will provide discharge pamphlet and individual face to face education to both groups as usual care. After discharge, instant messaging supportive enquiry service will be provided to both groups via smartphone apps. For intervention group, principal investigator will assess subject health care needs prior to intervention. Two extra sessions, 20 minutes, face to face, individual self-management education with aid of computer, track log sheet will be provided to intervention group. Concept of motivational interviewing will be incorporated as complement teaching strategy to facilitate self-management learning. Principal investigator will be responsible to deliver burn self-management education upon discharge. Intervention group will receive "Rehabilitation Booklet for Burn Patients" upon discharge. After discharge, only intervention group subject receives two sessions, 10 minutes, telephone follow up calls and five personalized chat-based messaging follow up will be provided. Besides that, self-management education information will be delivered to intervention group via instant messaging service as well. Ad-hoc instant messaging support will be provided to both groups if required.

Inulin in Burn-induced Insulin Resistance

In this clinical trial, investigators will test the effects of dietary supplement inulin, on the reduction of insulin resistance developed as a result of burn injuryy.