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Burns clinical trials

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NCT ID: NCT03333941 Completed - Burns Clinical Trials

Continued Access to the Recell® Device for Treatment of Acute Burn Injuries

Start date: October 26, 2017
Phase:
Study type: Observational

The overall purpose of this continued access study is to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the ReCell® Autologous Cell Harvesting Device is under FDA review. This is a prospective, multicenter, single-arm observational study to evaluate the safety and clinical performance of the ReCell® device when used as an adjunct to meshed autografts in patients with acute thermal burn injuries requiring skin grafting for closure.

NCT ID: NCT03313076 Terminated - Clinical trials for Chronic Pain Following Thermal Burn Injury

Vitamin D and n-3 Polyunsaturated Fatty Acids (PUFAs) to Prevent Chronic Pain Following Major Thermal Burn Injury

Start date: July 19, 2018
Phase: Phase 2
Study type: Interventional

The goal of this study is to develop a safe, effective, and readily available treatment that will prevent chronic pain following Major Thermal Burn Injury (MThBI). Burn survivors are prone to develop chronic pain and there is an urgent unmet need for preventative treatments. The preventative treatments proposed for this study, Omega-3 Fatty Acids (O3FA) and Vitamin D have been selected given effectiveness across a range of painful musculoskeletal disorders and their wide availability and low cost. This study is a 2x2 factorial, double-blind, placebo-controlled randomized controlled trial test for the effectiveness of O3FA and Vitamin D to prevent chronic pain development. Burn survivors will be enrolled who have experienced thermal burns that cover less than 30% total body surface area that are severe enough to warrant surgical management, which represents the most common burn injury characteristics. Patients will be enrolled within 72 hours of their burn, and randomized via 1:1:1:1 allocation to receive placebo, O3FA, Vitamin D or both. The investigators will obtain blood samples on enrollment and at 6 weeks to assist in elucidating key mechanisms by which O3FA and Vitamin D reduce chronic pain following MThBI. Chronic pain severity, assessed with a 0-10 numeric rating scale at 6 weeks, 3 months, 6 months and 1 year will be entered into a repeated-measures model. Model estimated contrasts will serve as the primary outcome.

NCT ID: NCT03312803 Completed - Burns Clinical Trials

Mini-autogenous Skin Grafts With Skin Homografts Versus Autogenous Skin Graft for Covering Post Burn Wounds in Children

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

A prospective study comparing the use of mini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children.

NCT ID: NCT03288844 Completed - Clinical trials for Limbal Stem Cell Deficiency Due to Ocular Burn

Follow-up Study After ACLSCT for Restoration of Corneal Epithelium in Patients With LSCD Due to Ocular Burns

HOLOCORE-FU
Start date: December 13, 2017
Phase:
Study type: Observational

This is a multinational, multicentre, prospective, non-pharmacological follow-up study of the clinical trial HOLOCORE. All patients transplanted with Holoclar in the HOLOCORE clinical trial who consent to participate will be enrolled in this prospective study and observed for at least 12 months.

NCT ID: NCT03279549 Not yet recruiting - Burn Clinical Trials

Research on the Key Technology of Burn Wound Treatment

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

Burns are common injuries in the daily life and wars. With the development of medical techniques, the mortality has been significantly reduced. However, the deformity and disability caused by hypertrophic scar have not been improved effectively since the wound repair technology is limited and controversial, especially on the early treatment of deep second degree burns. The prognosis of burns is of great difference. In recent years, the promotion of wound repairing technologies provides a new opportunity for improving the quality of wound healing and solving the problem of scar formation. Although some new methods and techniques have shown significant efficacy in clinic, clinical researches with large samples conducted in multiple centers are still deficient, impeding the evaluation of their superiority. Therefore, the current protocol focuses on the repair of deep second degree burns based on previous researches. There are four types of treatment protocols for wounds. Patients were divided into four groups randomly, including regular dressing change group, controlled debridement + biological dressing covering group (xenogeneic acellular dermal matrix), controlled debridement + epidermal cell cultivation group, controlled debridement + bFGF treatment group. The wound healing rate, healing time and scar formation were observed. The availability and security were evaluated. Further more, treatment guidelines and expert consensuses on deep second degree burn wounds were concluded. Above studies are important to promote the treatment of deep second degree burns to be scientific, standardized and professional in China.

NCT ID: NCT03271268 Recruiting - Burns Clinical Trials

Cardiovascular Biomarkers and Lung Edema in Severe Burns Patients

CAROLE
Start date: August 6, 2017
Phase: N/A
Study type: Observational

Burn injury leads to hypovolemic then distributive shock. Fluid resuscitation remains the cornerstone of initial treatment of burn shock. However, fluid rescucitation can lead to fluid overload, which manifests most notably as lung edema. The peptide NT-pro-BNP, a biomarker of cardiac congestion secreted by the myocardium, as well as plasma CD146, an endothelial factor involved in angiogenesis and a marker of vascular congestion, may help identifying patients with risk of pulmonary edema and hypoxia . Our hypothesis is that these biomarkers may predict the occurence of pulmonary edema in severe burns patients.

NCT ID: NCT03248154 Withdrawn - Wound Clinical Trials

Biofilm Infection in Adults and Children Burn Injury

Start date: January 2017
Phase: N/A
Study type: Interventional

The objective of the study is to analyze the different implications (such as graft loss and conversion of indeterminate depth burns) of biofilm infections in burn patients. Additionally, it also aims at comparing children's resistance to biofilm infection at wound site than adults'. 300 subjects from 3 different age groups will be enrolled in 3 arms.

NCT ID: NCT03242434 Terminated - Burns Clinical Trials

Investigation of Thermal Injury on Intestinal Permeability in Both Thermal Injury and Healthy Participants

Start date: January 29, 2018
Phase: Phase 1
Study type: Interventional

This longitudinal, prospective study aims to establish the magnitude and time course of changes in intestinal permeability; establish the optimal method for assessment of intestinal permeability in thermally injured participants: describe the participant population most likely to benefit from a new medicinal product which could prevent changes in intestinal permeability; and improve our understanding of the links between intestinal damage, changes in the gut microbiome and microbial translocation to the systemic circulation following thermal injury. The key factors of interest in this study are to understand the impact of thermal injury on intestinal permeability in thermally injured participants compared to healthy participants; and to understand the changes in intestinal permeability over time. Approximately 15 eligible healthy participants and 25 thermally injury participants will be included. The sugar test material (STM) comprises of Lactulose, Mannitol and Sucralose and will be intermittently administered enterally to all the participants. The full duration of the study for healthy participants will be approximately two weeks and 6 months for thermally injured participants. In order to enter this study thermally injured participants will be required to co-enroll in this study and an allied study entitled: A Multi-center, Prospective Study to Examine the Relationship between Neutrophil Function and Sepsis in Adults and Children with Severe Thermal Injury (SIFTI-2). (reference number IRAS ID: 200366).

NCT ID: NCT03242395 Completed - Depression Clinical Trials

PRIME: Cognitive Outcome Following Major Burns

PRIME
Start date: October 2014
Phase: N/A
Study type: Observational

PRIME aims to demonstrate through neurocognitive assessment that BICU patients will have a degree of neurocognitive dysfunction following a major burn, that this neurocognitive dysfunction is due to an underlying neuroinflammatory process by fMRI neuroimaging techniques, and that the neurocognitive deficit is associated with a reduced quality of life.

NCT ID: NCT03240718 Completed - Burns Clinical Trials

Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn Patients

Start date: February 2015
Phase: N/A
Study type: Interventional

This is a randomized, controlled, within-patient, single-blinded, pilot study that will evaluate the impact of laser treatment on burn HSc relative to self-matched control scars. The studied primary outcomes of treatment are scar pliability, thickness, vascularity, pain, itch and patient satisfaction.