Clinical Research Directory

The Effect of Hologram Application on Pain, Anxiety, and Fear Levels in Children During Burn Dressing: A Randomized Controlled Study

The process of dressing burn injuries has been shown to cause both physical and psychological difficulties. In children, this process is particularly associated with intense pain and anxiety. Consequently, in addition to pharmacological interventions, non-pharmacological methods such as distraction are employed. In recent years, the utilization of holograms as a method of alleviating pain has emerged as a novel approach. The employment of these visual illusions has been demonstrated to effectively distract children, thereby providing a means of reducing discomfort. The objective of this thesis is to evaluate the effects of hologram application on pain, anxiety, fear, and vital signs during burn dressing in children.

Blue Light for Donor Site Healing in Burn Patients

The goal of this clinical trial is to learn whether blue light (BL) photobiomodulation can improve the healing of donor site (DS) wounds in patients with burn injuries who are treated surgically. This study will investigate whether adding BL therapy to the usual treatment can improve healing and patient outcomes in adult patients with intermediate and deep burns. The main questions it aims to answer are: * Does the use of BL therapy combined with standard treatment reduce the healing time of DS compared with standard treatment alone? * Does BL therapy improve wound conditions, reduce pain, and decrease signs of infection during the healing process? * Is BL therapy safe and well tolerated when applied to DS? * Does the treatment improve the long-term quality of the scar after healing? Researchers will compare DS areas treated with standard care alone to DS areas treated with standard care plus BL therapy to see whether BL improves healing outcomes. Each participant will serve as their own comparison: two different DS areas on the same patient will receive the two different treatments. Participants will: * Receive the standard treatment for DS, which includes routine wound care and dressing * Receive BL therapy on one DS area in addition to the standard treatment, while another DS area will receive standard treatment alone * Attend regular clinical evaluations where clinicians will assess wound healing and the condition of the wound bed * Report their pain levels using a simple numeric scale during the healing period * Undergo skin swabs to detect possible signs of infection * Be monitored for any local side effects, such as redness, burning sensation, warmth, itching, or skin irritation related to the light treatment After the DS have completely healed, participants will return for follow-up visits at 1 month and 3 months. During these visits, researchers will evaluate the quality of the scars and monitor for any late side effects.

Multicenter Single-arm Trial to Investigate Clinical Outcomes When Cohealyx™ is Used for Full Thickness Wounds

The goal of this study is to look at clinical outcomes when Cohealyx Collagen Matrix is used to treat full thickness wounds after surgical excision in patients that require a skin graft to heal their wounds. The main question it aims to answer is how long does it take for Cohealyx to support definitive closure.

Gamified Approach To Burn Education

The goal of this clinical trial is to evaluate whether different educational strategies can improve knowledge acquisition regarding burn prevention and first aid among students enrolled in a community-based preparatory course. The main questions it aims to answer are: Does participation in a serious digital game improve knowledge about burn prevention and first aid compared with a traditional lecture? Researchers will compare a serious digital game with a face-to-face educational lecture to determine differences in knowledge acquisition and participant satisfaction between the two educational approaches. Participants will: Receive a brief (5 minutes) standardized introductory explanation about basic concepts of burns; Be randomized to participate in either a serious digital game or a face-to-face educational lecture; Complete knowledge assessment questionnaires prior to and after the intervention; Complete a satisfaction questionnaire; Attend a follow-up assessment two weeks after the intervention.

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)

Effect of Laughie on Pain Anxiety and Pain Level in Second-Degree Burn Patients

Burn injuries are traumatic conditions that seriously affect individuals' quality of life, both physically and psychologically. Second-degree burns, in particular, affect the superficial and/or deep layers of the dermis, causing intense pain and extensive tissue damage. Pain in burn patients is not only physical; it combines with emotional stress, fear, and uncertainty to increase anxiety levels. This study is a parallel group-randomised controlled trial designed to evaluate the effects of the Laughie exercise, administered prior to dressing changes in individuals diagnosed with second-degree burns, on post-dressing pain anxiety levels and pain intensity.

Clinical Effectiveness of a Patient-tailored Orthosis Based on 3-dimensional (3D) Scanner Modeling and 3D Printing Technology for Microstomia Caused by Burns : Pilot Study

Mircostomia is not clearly defined in terms of size, but is diagnosed when it causes difficulty in eating, pronounciation, or maintaining oral hygiene. Although various treatments have been applied to microstomia caused by mouth contracture after facial burns, there is no established protocol yet. This study aimed to confirm the clinical usefulness of patient-customized mouthpiece using 3D scanner modeling and printing technology.Each participant's mouths were scanned using a 3D scanner (Peel 3, Peel 3D, Canada). The scanned model was imported into the modeling software (Geomagic Design X, 3D Systems, USA). After modeling the mouthpiece to fit the maximum horizontal and vertical length of the mouth and the thickness of the lips, it was manufactured using a 3D printer (Form 4B Medical, Formlabs, USA). The participant was advised to wear the appliance throughout the day except during meals. As a primary outcome, the vertical and horizontal distances of the mouth were measured before and after wearing the patient-customized mouthpiece for 2 months. As secondary outcomes, the biological scar properties, the Vancouver Scar Scale (VSS), and the Patient and Observer Scar Assessment Scale (POSAS) scores were evaluated.

The Lateral, Anterior, Medial (LAM) Femoral Cutaneous Block: A Case Series Harborview Medical Center, Seattle, WA

Skin donor sites in patients undergoing split-thickness skin grafting surgeries can be very painful postoperatively. This site is most often the anterolateral thigh, the pain at which location can traditionally be covered by a fascia iliaca nerve block, although that comes with the disadvantage of losing motor functions in the femoral nerve distribution. The LAM nerve block, which is relatively new, aims to provide analgesia in the distribution of the lateral and anterior femoral cutaneous nerves. In short, this nerve block would decrease the sensation of the anterolateral thigh area without affecting the motor function of the leg. Investigators aim to study the consistency and coverage size of sensation changes by mapping out the area after the block in each patient.

Autologous Fat Grafting in Upper Limb Burns Scars

Burn injuries are a complex form of trauma with a high risk of complications. When they affect the upper limbs, patients often develop functional contractures and/or pathological scars that significantly impair mobility, quality of life, and psychological well-being. Current treatments-such as surgical interventions and corticosteroid injections-offer limited effectiveness, require prolonged therapy, and are associated with discomfort, multiple sessions, and indirect costs. Autologous fat grafting, a regenerative technique based on the transfer of the patient's own adipose tissue, has emerged as a promising alternative. It combines biocompatibility with regenerative and anti-inflammatory properties that may improve both function and scar quality. This randomized clinical trial aims to evaluate the efficacy of fat grafting in patients with post-burn upper limb sequelae compared to standard treatment (surgical release and/or corticosteroid injections). Patients will be prospectively followed and assessed using validated scar scales and functional outcomes.

Microbiota in Children With Severe Burn Injury

The research protocol consists of taking aliquots of biological specimens from skin swabs, nasopharyngeal swabs, and fecal swabs. the samples will be taken at time 0 of admission to the Pediatric ICU, one week after admission, and two weeks after admission to compare the bacterial populations present at the different sampling sites.

Effect of Solutions Used in Burn Wound Irrigation on Healing, Pain, Fear and Anxiety: Randomized Controlled Study

Burn, skin and/or subcutaneous tissues; It is an acute injury that causes traumatic lesions by exposure to thermal, chemical, mechanical or electrical agents. Among all traumatic injuries, burns are the most common type of injury and affect the entire body system. The World Health Organization reports that approximately 180,00 deaths per year are due to burns, making it the fifth most common type of childhood injury. It is also stated that 80% of burned children have hot water burns. Treatment is in two ways: surgical and non-surgical. The type of burn, its size, depth and the individual characteristics of the child affect the type of treatment. Non-surgical treatment is always the first choice in burn treatment. The primary method of this method is burn dressings. Before dressing, the burn surface must be cleaned/irrigated with an appropriate antiseptic solution to remove metabolic wastes and tissue exudate. The aim here is to prepare a suitable environment for the burn wound to heal and to accelerate the healing process. In the literature, it is recommended to use various antiseptic solutions such as 0.9% NaCl, 0.5% chlorhexidine and hypochlorous acid for irrigation of burn wounds. Applying these solutions involves physical contact with the wound, and this contact may cause pain in the child. Additionally, the temperature and pH of the solution may cause discomfort. The pain that occurs during the irrigation process can further intensify anxiety and fear. However, it is not known which burn solutions used cause more pain, anxiety and fear. In this project, the effects of irrigation solutions used in the care of pediatric burn wounds on pain, fear, anxiety, infection development and healing will be examined. Child patients aged 5-10 years old with limb burns who present with hot water burns and do not have an indication for hospitalization will be included in the project. Children coming to burn dressing will be divided into three groups by simple randomization method. The burn wound of children in the first group will be irrigated with 0.09% NaCl, the children in the second group will be irrigated with 0.5% chlorhexidine, and the burn wound of children in the third group will be irrigated with hypochlorous acid solution. During irrigation of the burn wound, the child's anxiety, fear and pain status will be evaluated. At the same time, the effectiveness of the irrigation solutions used on the development of infection on the wound and its effectiveness on healing will be examined. For this reason, the burn wound will be monitored every three days. For this reason, children will be called to the burn clinic for dressing every three days. Before each dressing, a wound swab sample will be taken to determine the infection status in the burn wound. The Bates-Jensen wound assessment tool will be used to determine the healing status of the burn wound, and this tool will be evaluated by the burn nurse and two pediatric surgeons. In total, children will be monitored for 12 days. At the end of the project, the effect of the solutions used in burn irrigation on infection and healing will be determined. At the same time, the effects of the solutions on anxiety, fear and pain in children will be evaluated. It is thought that the data obtained as a result of the project will contribute to the development of a burn wound care protocol.

Efficacy of Hydrotherapy on Balance in Neuropathic Patients Post-Burn

Balance problems are common among neuropathic patients following burns, primarily due to sensory and motor impairments.The goal of the study is to investigate the effect of a hydrotherapy program on balance in neuropathic patients following burns. It is a randomized controlled study will be conducted on fifty male patients (age range from 35 to 45 years) with polyneuropathy following lower limb burn injuries, mainly at the sole of the foot, with 3rd-degree injuries and 30% burn extent. Balance will be assessed before and after treatment using the Biodex Balance System and the Berg Balance Scale (BBS). Patients will be randomly assigned into two equal groups: Group A (study group) will receive hydrotherapy sessions including stretching, resistance, and balance exercises in water. Group B (control group) will receive traditional land-based balance exercises only.

Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns

This multicentre, randomised, double-blind, dose-finding, active- and placebo-controlled Phase II clinical trial will evaluate the safety, efficacy, pharmacokinetic profile, and immunogenicity of KJ101 for the debridement of deep second-degree burns. The trial will provide supporting evidence for subsequent Phase III trials.

Paraffin Wax and Exercise Prospective

This study is being done to test if paraffin wax can be used to improve the range of motion and function for scars across joints when used in combination with scar rehabilitation therapy sessions. For those randomized to receive it, the paraffin wax will be used alongside the participants' exercise therapy treatments. Currently, treatments that are used in addition to rehabilitation therapy for increasing range of motion across joints in the burn population are limited. By getting more information about how paraffin wax may or may not work, patients in the future that have scars may be able to be helped.

Utilizing 3D Imaging for Burn Wound Assessment

The goal of this prospective cohort study is to determine if the DermaMonitor camera can accurately determine burn size in patients with 1st, 2nd, or 3rd degree burns, with exploratory aim of testing a new Artificial Intelligence (AI) program for determining burn depth. The main aims are: 1. The primary aim of this study is to assess an objective process for the classification of burn size using the DermaMonitor wound camera. 2. An exploratory aim of this study is to begin to train an Artificial Intelligence (AI) program to classify burn depth (1st, 2nd, 3rd degree) using the 3D images from this novel wound camera. Researchers will compare DermaMonitor size classification and AI depth classification to clinician determinations. Participants will have images taken of their burn. Participation ends when the images are taken.

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).

Thromboelastography to Study Burn Coagulopathy

This pilot study examines the use of thromboelastography (TEG), a specialized blood test, to evaluate clotting abnormalities in burn patients. The study aims to understand how burn injuries impact the body's ability to form and break down blood clots over time. Specifically, the investigators will research whether the percentage of total body surface area burned (%TBSA) is associated with changes in blood clotting, track the evolution of clotting patterns during the first four weeks following a burn injury, and explore whether these changes can predict recovery or complications. By providing new insights into clotting dynamics in burn patients, the study seeks to improve diagnostic methods, enhance monitoring strategies, and guide treatments to optimize patient care and outcomes.

Determining Elements of Anti-Fungal Immunity in BURN Patients

Scientific justification Invasive fungal diseases (IFDs) pose a substantial threat, especially in immunocompromised patients, necessitating urgent research focus and therapeutic advancements. The IFI-BURN study, involving a cohort of patients with severe burn injury (n=276), revealed a significant IFD incidence of 31.6% and underscored their critical impact on morbidity and mortality. While fungi are present everywhere, for moulds within the environment and for yeasts within our microbiota, why certain patients develop IFDs and others do not, remains poorly understood. The answer most likely resides in the impact of the burn injury on the immune response, loss of skin barrier and particular predisposing immune phenotype of patients. The immune system is composed of both cellular and humoral components, but the latter is far less studied in antifungal immunity although they exert multiple antimicrobial mechanisms.

Low-Dose Ketamine Infusion During Burn Wound Care

The current standard of care (SOC) (i.e. fentanyl and midazolam) offers limited efficacy for preventing or relieving pain. Ketamine infusions may provide the benefits of analgesia, minimize adverse events, and reduce opioid use. The purpose of this study is to determine if adding a low dose ketamine infusion during wound care will safely provide pain relief for patients with burn injury.

Sensory Motor Training on Foot Weight Distribution in Patients With Foot Burn

The purpose of the current study is to investigate the effect sensory motor training on foot weight distribution and postural stability in patients with foot burn.