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Burns clinical trials

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NCT ID: NCT05126017 Not yet recruiting - Burns Clinical Trials

Examine the Validity of a Panel of Objective Burn Scar Measurement Tools

BOSS-2
Start date: January 2022
Phase:
Study type: Observational

Reliable scar assessment is essential not only when designing clinical trials to investigate the efficacy of new and existing scar therapies, but also in everyday, clinical practice, to examine the progress of our patients' care. Subjective assessments are extremely important; they demonstrate to the patient the changes and improvements in their scars since the primary burn injury. Nevertheless, clinicians require reliable, validated, and objective tools which can yield measurable and reproducible outcomes. These are ultimately needed to achieve the goal of reducing the physical and psychosocial burden of scarring through compelling research. Previously, a pilot study (BOSS-1) was conducted in 55 patients with post burn hypertrophic scars. The investigators measured, among other parameters, scar thickness, density, and pliability, using a panel of objective scar assessment tools, alongside standard subjective measurements (questionnaire-based), and skin biopsy assessments. Measurements were performed at a single time point which varied from 3 months to 6 years post burn injury. This work indicated that measuring scar thickness, pliability and colour together, may provide a global scar objective score. BOSS-2 is a multi-centre study that will validate the preliminary findings in BOSS-1.

NCT ID: NCT05096559 Recruiting - Burn Shock Clinical Trials

Evaluation of Sublingual Microcirculation in Burn During Resuscitation

Start date: February 1, 2021
Phase:
Study type: Observational

The adequacy of fluid resuscitation will be monitored in burn patients using microcirculation. Microcirculation camera will be placed on the base of the tongue and at different four quadrants. • Microcirculation parameters at baseline and after 8h , 16h and 24h of fluid resuscitation will be recorded. Fluid resuscitation with lactated ringer according to Parkland formula (4 ml/kg/%TBSA) 50% given during the first 8 hours, with the remainder given during the following 16 hours, will be initiated to maintain a urinary output of 0.5ml/kg/hr.Norepinephrine infusion will be started in case of circulatory failure at a rate of 0.02mic/kg/min to maintain MAP of 65-70mmHg.

NCT ID: NCT05084248 Recruiting - Clinical trials for Vitamin D Deficiency

Vitamin D Deficiency in Adults Following a Major Burn Injury

Start date: September 29, 2022
Phase: Phase 4
Study type: Interventional

This is a single site double blind randomized controlled trial of replacing Vitamin D for Vitamin D-deficient burn patients at a current recommended dose (400 IU daily) versus a higher dose (4000 IU daily). Capsules will be made in a compounding pharmacy and will look identical. Randomized controlled trial. People who meet the selection criteria will be randomized to either low or high dosage of Vitamin D. Treatment arm is high dose Vitamin D (4000 IU), and control is low dose Vitamin D (400 IU). Main outcome variables include PROMIS-29 measures of physical health, mental health and social health, the Veterans RAND 12 Item Health Survey (VR-12), and the 4-D Itch Scale. Secondary outcome variables include subject demographics, injury demographics and characteristics.

NCT ID: NCT05078385 Recruiting - Burns Clinical Trials

Safety of Extracellular Vesicles for Burn Wounds

Start date: August 10, 2023
Phase: Phase 1
Study type: Interventional

Treatment of patients with deep second degree burns of the skin with extracellular vesicles (EV) isolated from bone marrow derived mesenchymal stem cells.

NCT ID: NCT05069922 Recruiting - Burns Clinical Trials

Randomized Trial of Fresh Frozen Plasma Versus Albumin in Acute Burn Resuscitation

FFP
Start date: February 17, 2022
Phase: N/A
Study type: Interventional

The investigators propose a prospective randomized trial to study fresh frozen plasma (FFP) versus albumin to determine the optimal colloid in burn resuscitations. This work addresses both FY20 focus areas, prolonged field care (PFC) and en route care, along with mitigating secondary effects of acute intervention, such as prevention of over resuscitation. Future military conflicts anticipate more extensive burn and blast injuries, and delayed evacuation. Therefore, the direct comparison of colloids used in burn resuscitation is critical to advancing battlefield medicine. Specifically, this work will provide the foundation for the use of freeze-dried plasma (FDP) in burn care by medical responders in PFC and en route care scenarios. The investigators hypothesize that FFP administration, and later FDP, in burn resuscitation is as safe as albumin, and more efficacious, in both reducing the total volume of fluid required in acute burn resuscitation and correcting burn endotheliopathy.

NCT ID: NCT05063409 Completed - Burn Injury Clinical Trials

Transfusion Ratio of Fresh Frozen Plasma (FFP) to Packed Red Blood Cell (PRBC) During Burn Excision and Grafting

FFP
Start date: September 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if burn injured patients who receive blood transfusions in the operating room have better outcomes when given transfusions at a set ratio (1:1)of PRBC to FFP. Traditionally, patients that need blood transfusions during surgery are given mostly packed red blood cells (PRBC) and some fresh frozen plasma (FFP). This is usually about 1:4 ratio of FFP to PRBC. In this study, we will compare this traditional approach (1:4) to a 1:1 ratio of FFP to PRBC during the operative period. The hypothesis of the study is that the use of FFP/PRBC ratio of 1:1, compared to a ratio of 1:4 will result in a(n) 1. decrease in the amount of blood transfused in the operating room 2. decrease in the amount of blood transfused during hospitalization 3. improvement in coagulation parameters (PT/PTT, INR, antithrombin III, Protein C and Fibrinogen in the operative period (from operation start to 12 hours post operatively) and at 24 hours postoperatively 4. decrease the hospital length of stay, lung dysfunction, infections, and mortality

NCT ID: NCT05059418 Not yet recruiting - Clinical trials for Burning Mouth Syndrome

Burning Mouth Syndrome - New Diagnostic Criteria and Treatment

BMS
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

The first part of this study is to optimize diagnostic criteria for BMS, i.e. not a clinical trial, and will not be covered in this application. The second part will compare topical treatment with clonazepam, capsaicin and placebo in a n-of-1 study design regarding effects of pain, pain-related disability, somatosensory changes in the trigeminal nerve and patient experience in patients with primary BMS or other oral mucosal pain. The patients will be treated for two weeks with each drug, with a one-week wash-out period in between. After the last washed-out period, the patients will be able to chose the treatment that they prefer the most and continue with that treatment during 6 months.

NCT ID: NCT05037916 Completed - Laser Burn Clinical Trials

Comparison of Laser Speckle Contrast Imaging and Laser Doppler Imaging in Burn Patients

COLA-B
Start date: April 15, 2019
Phase:
Study type: Observational

Timely and accurate estimation of the surface area and depth of a burn injury is essential for determining an appropriate treatment modality. Inappropriate or inadequate treatment may result in complications and increased societal costs. Burn depth is determined by subjective assessing the characteristics of burn injury. Some objective methods are available (e.g., biopsy and histology, thermography and laser doppler imaging), but these are cumbersome. In assessing burn wounds, laser Doppler imaging (LDI) which has a good correlation with histology, is currently the most widely used and validated noninvasive measurement tool. In addition, it is the only technique that has been approved by the U.S. Food and Drug Administration. However, the use of LDI is accompanied by some disadvantages. The current commercial available LDI device is rather costly, cumbersome and has a poor spatial resolution. Another laser-based technique, laser speckle contrast imaging (LSCI), works with a similar principle and might become an alternative for LDI. LSCI has some advantages over LDI such as higher spatial resolution, much easier to position, no valuable time wasted on setting up the instrument, easy to take several images of burns that have a large surface area and/or much curvature, faster measurements, fraction of the time needed for getting a high-quality measurement, able to follow changes in the perfusion in real time. In contrast to the LDI, the LSCI has not been validated in terms of a diagnostic tool for stratifying the severity of a burn (based on LDI color coding). Consequently, we will compare the LSCI with LDI to improve burn care by providing cheaper, faster and higher resolution imaging technique.

NCT ID: NCT05023135 Completed - Burns Clinical Trials

DeepView SnapShot Portable (DV-SSP): Device Training Study

Start date: September 7, 2021
Phase:
Study type: Observational

The purpose of this study is to continue development and validation of an algorithm for burn healing assessment by the Spectral MD DeepView device and provide burn healing potential assessment.

NCT ID: NCT05019144 Completed - Burns Clinical Trials

Telemedicine Optimized Burn Intervention

TOBI
Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Because burn patients and their caregivers often live long distances from regional burn centers, access to expert burn care is limited, resulting in a negative effect on adherence to treatment and a higher risk of wound complication. A novel smartphone application synchronized with a web portal for providers, called the Telemedicine Optimized Burn Intervention (TOBI), was recently developed to enable burn experts to direct burn wound care while the patient and caregiver are home through text messaging, image transfer, and video-conferencing. The goal of the present study is evaluate TOBI compared to face-to-face care as usual for pediatric patients/caregivers visiting a burn center. This study will also assess the feasibility of conducting a larger-scale clinical trial in several burn centers. The app will allow the physician and patient to make instant decisions regarding treatment, allowing for "turn on a dime" treatment decisions, rather than having the patients and families wait for scheduled clinic appointments, often hours away from home. This "on demand" medical care takes an innovative approach to increasing access to burn experts through smartphone technology and addressing adherence to prescribed treatment by increasing communication between provider and patients.