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Burns clinical trials

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NCT ID: NCT04765202 Active, not recruiting - Clinical trials for Full Thickness Thermal Burn

StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns

StrataSOMA
Start date: May 28, 2021
Phase: Phase 2
Study type: Interventional

Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the patient's own body (donor site) to the burned part. Autografting is the usual treatment for full-thickness (FT) burns. It works to close the wound, but can cause other problems: - Donor sites are painful, can become infected or scarred, or can even become FT wounds themselves - Treatment problems can require more grafting - Additional surgery increases risk of medical problems caused by the treatment Stratatech is trying to find a safe and effective treatment option for severe burns that uses less donor skin. All participants in this study will receive meshed autograft on one part of their burn (AG Tx). They will receive more widely meshed than AG Tx site autograft with a StrataGraft covering (SOMA Tx) on a different part of their burn. Each participant will be involved in the study up to about 14 months.

NCT ID: NCT04467619 Active, not recruiting - Burns Clinical Trials

Illusory Movements in Patients With Burns

Immobile
Start date: June 26, 2020
Phase: N/A
Study type: Interventional

Background. Large burns are the cause of extensive skeletal muscle devastation. The possibilities of rehabilitation of such patients are very limited, which contributes to the risk of metabolic failure and long-term musculoskeletal disorders. Illusory movements are a relatively new method of physiotherapy, which through functional proprioceptive stimulation enables the integration and networking of muscle units and has a neurotrophic effect on the cerebral cortex. In our pilot study, we demonstrated that illusory movements significantly increased basal energy expenditure in extensively burned patients in a catabolic state and with healing impairment in the later stage of burn disease. However, the metabolic effects of illusory movements have not yet been studied. Tested hypotheses. 1. The use of illusory movements is suitable for the rehabilitation of patients with burns on 20% or more of the total body surface area (TBSA) in the early phase of the burn disease. 2. The use of illusory movements in these patients attenuates the extent of muscle catabolism. Method. Pragmatic crossover study. Twenty patients with burns on 20% or more of the body surface area will be divided into two groups. They will be rehabilitated early or delayed by illusory movements for 14 days. Among other things, the following metabolic parameters will be monitored: nitrogen balance, basal and resting energy expenditure (BMR, REE), insulin resistance (IR), myokinins levels, muscle mitochondrial function and their morphology, and ultrasound cross-sectional diameter of the rectus femoris muscle. The control group will consist of ten healthy volunteers, in whom resting energy expenditure before and after using illusory movements exercise will be measured.

NCT ID: NCT04456127 Active, not recruiting - Scar Clinical Trials

CO2 Laser Revision for Burn Related Donor Site Scars

Start date: January 21, 2020
Phase: N/A
Study type: Interventional

Scarring from burn wounds remains a chronic and often severe sequela of burn injury. Burn wounds may be left to heal by secondary intention or treated with surgical skin grafting; in both circumstances, significant scars likely result. When surgical skin grafting is employed, skin graft harvest sites ("donor sites") likewise result in clinically significant scars. This study will have interventional and observational components. Patients will receive the standard fractional ablative CO2 treatments to their scars resulting from burn wounds allowed to heal by secondary intention and/or those treated with skin grafts. These will be prospectively observed for the duration of the study as well as adjacent normal skin. In addition, a donor site that meets inclusion criteria that would not have otherwise received LSR will be identified as a treatment site. Patients with have one half of their donor sites randomized to standard of care (SOC) treatment, which consists of wound dressings, compression therapy, physical and occupational therapies and the other half randomized to SOC + ablative fractional CO2 laser therapy (LSR).

NCT ID: NCT03876340 Active, not recruiting - Burns Clinical Trials

Impact of a Clinical Decision Algorithm on Length of Hospital Stay and Costs of Care of Burned Patients

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Reliable and valid assessment of burn wound depth or healing potential is essential to treatment decision-making, to provide a prognosis, and to compare studies evaluating different treatment modalities. Clinical evaluation remains the most widely used method for assessing the depth of the burn wound. This method is based on the subjective evaluation of visual and tactile characteristics of the wound, with an accuracy ranging between 50 to 70%; which is not precise to guide clinical decision making. The aim of these study is to validate thermography as a therapeutic approach to predict treatment modality based on thermographic imaging of the wound and its healing potential obtained during the first three days of treatment of either healing by re-epithelization, requiring skin grafts, or requiring amputations. By performing this algorithm, it is expected to address three aspects of the management of patients with acute burns: early clinical diagnosis, initial management decisions and reduction of hospitalization days.

NCT ID: NCT03227146 Active, not recruiting - Burns Clinical Trials

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

Start date: October 25, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT03077269 Active, not recruiting - Burns Clinical Trials

Understanding Coagulation and Inflammation in Burns

Start date: May 1, 2016
Phase:
Study type: Observational

The purpose of this study is to understand what happens to platelets and blood clotting factors in burn patients over time. This study will also examine the role of microparticles (MPs), nanoparticles (NPs), and micro RNA in burns. The investigators will be looking at small particles of cells that are released into the blood. These particles have been found to be important in a variety of different diseases. The investigators believe that MPs, NPs, and micro RNA may play a role in development of inflammation, and infections in burn patients. Thus, hopefully, this study will help understand how to minimize transfusions and bleeding in burn patients as well as how to reduce inflammation and infections in burn patients.

NCT ID: NCT02607852 Active, not recruiting - Burns Clinical Trials

Feedback System of PROMS in Children With Burns

Start date: April 8, 2015
Phase: N/A
Study type: Interventional

The primary objective of the overall study is to determine the feasibility and usefulness of a feedback system that delivers BOQ results to physicians in "real time" during outpatient encounters using iPads.

NCT ID: NCT02278718 Active, not recruiting - Thermal Burns Clinical Trials

A Study to Evaluate the Efficacy and Safety of NexoBrid in Children With Thermal Burns Compared the Standard of Care

Start date: May 2015
Phase: Phase 3
Study type: Interventional

This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns. The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).

NCT ID: NCT01843686 Active, not recruiting - Acute Burns Clinical Trials

Using Autologous Platelet Rich Plasma (PRP) Gel to Treat Deep 2nd and 3rd Degree Burns

Start date: April 2013
Phase: Phase 1
Study type: Interventional

This study will demonstrate the safety of the application of autologous platelet rich plasma (PRP) gel following excision and autologous skin grafting of acute deep 2nd and 3rd degree burns. The study will be a randomized, double-blinded controlled safety study. Investigators expect that the PRP will deliver improved hemostasis and growth factors at the wound site thus increasing the effectiveness of treatment at the wound site. This will lead to rapid production and delivery of an autologous therapy that should minimize additional morbidity to the patient.

NCT ID: NCT01828541 Active, not recruiting - Burns Clinical Trials

Hypnosis for Pain and Itch Following Burn Injuries

Start date: May 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether hypnosis will decrease the intensity of either pain or itch in patients who have sustained a burn injury. Primary hypothesis: Hypnosis will provide more effective relief from post-burn itch and pain than a control intervention at 1-month, 3-months, 6-months and 1-year post-burn injury. Secondary hypothesis 1: Subjects treated with hypnosis will report better sleep quality and fewer symptoms of Post Traumatic Stress Disorder (PTSD). Secondary Hypothesis 2: Subjects treated with hypnosis will require less escalation of the gabapentin doses and have lower average pain scores than those in the control group. Exploratory Hypothesis: Subjects who will randomize to the hypnosis treatment group early after injury will report lower rates of neuropathic pain and itch than subjects who will be enrolled in the study and receive hypnosis later in the healing process.