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Thermal Burn clinical trials

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NCT ID: NCT06223269 Recruiting - Wound Heal Clinical Trials

Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting

Start date: May 9, 2024
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of realSKIN® to provide complete wound closure of mixed-depth, full-thickness burn wounds as an alternative treatment to autografting.

NCT ID: NCT05167461 Completed - Burns Clinical Trials

AutoMated BUrn Diagnostic System for Healthcare (AMBUSH)

AMBUSH
Start date: May 24, 2022
Phase:
Study type: Observational

The primary objective of this study is to develop a high accuracy and automated system that can provide early assessment of burn injuries with at least 90% accuracy in absence of burn experts, using AI and FDA cleared harmonic ultrasound TDI data based on the analysis of mechanical and hemodynamic properties of the subcutaneous burned tissue. Data collected in this study will lead to the development of better diagnostic tools that could inform clinical burn practices by enabling doctors to determine burn depth and the need for surgery with greater speed and accuracy, resulting in better clinical outcomes.

NCT ID: NCT05084183 Recruiting - Thermal Burn Clinical Trials

Evaluation of the Effectiveness of PermeaDerm® (PD) as Compared to Mepilex Ag®

Start date: February 2, 2022
Phase: N/A
Study type: Interventional

A total of 68 adult and pediatric patients who suffer from at least one discrete partial thickness thermal burn wound (Grade II) will be recruited. Subjects will be randomized (1:1) to either PermeaDerm® or Mepilex Ag®. Evaluations will occur at 7, 14 and 21 days with long term follow-up at 6 and 12 months.

NCT ID: NCT04684121 Withdrawn - Thermal Burn Clinical Trials

Study of the Efficacy and Safety of Granexin® Gel to Improve Burn Wound Healing

Start date: August 1, 2022
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy of Granexin® gel to promote accelerated healing of second-degree (deep partial thickness) thermal burns.

NCT ID: NCT04500314 Completed - Thermal Burn Clinical Trials

Efficacy of Whole-body Vibration on Balance Control, Postural Stability and Mobility After Thermal Burn Injuries.

Start date: August 5, 2020
Phase: N/A
Study type: Interventional

This study will be conducted to investigate the effect of whole-body vibration device on Balance control, postural Stability and mobility after thermal burn injuries.

NCT ID: NCT04368117 Recruiting - Burn Injury Clinical Trials

STAT: Standard Therapy Plus Active Therapy

STAT
Start date: October 26, 2020
Phase: N/A
Study type: Interventional

The objective of the study is to assess the efficacy of STAT, an activity-based therapy protocol compared to standard therapy (ST) to improve functional outcome and reduce disability in patients recovering from burn injury. This randomized multi-center trial is designed with two parallel treatment groups: STAT and ST. Efficacy of the STAT protocol will be determined through comparison to the ST only group. It will be conducted at seven burn centers.

NCT ID: NCT04138394 Recruiting - Shock Clinical Trials

VItamin C in Thermal injuRY: The VICToRY Trial

VICToRY
Start date: July 24, 2020
Phase: Phase 3
Study type: Interventional

This study aims to show that giving high dose, intravenous vitamin C in addition to standard care to burned critically ill patients will be associated with less organ dysfunction, improved survival and a quicker rate of recovery. In this study, all patients will receive standard care and of the patients will also receive high dose intravenous vitamin C, while the other half of patients will receive placebo.

NCT ID: NCT04073030 Completed - Burns Clinical Trials

Burn Injury In a Child Due to Cyanoacrylate-Based Nail Glue- Case Report and Literature Review

Cyanoacrylate
Start date: June 1, 2019
Phase:
Study type: Observational

Cyanoacrylate is used in the manufacturing of surgical adhesives, nail glue and super glue. After contact with cotton or wool, among other substances, a reaction is ignited, inflicting thermal damage to the skin underlying clothes. Nine papers have been published about such an incidence, majority of which involve children. In this paper, a four-year-old girl suffering from mixed-first-and-second degree burns due to cyanoacrylate spillage over the digits, anterior aspect of the right thigh and a patch of the skin on the left upper abdomen, spanning 4% of the total body surface area. The clothes were forcefully removed by the mother and shampoo was applied over the area. In the ER, irrigation with normal saline was done followed by dressing with paraffin- impregnated gauzes and silver sulfadiazine. Volar slabs were placed on the hands. The dressing in the hands was later changed to fusidic acid as the burn healed. Silicone sheet dressing was initiated twenty-eight days later after complete healing of the burned skin. An experiment conducted by the authors showed no difference in the pH of different cyanoacrylate products. The pH was not changed after applying shampoo over the nail glue immersed dip-stick. This paper aims to improve awareness about proper first-aid management which predicts the quality of the outcome. Further emphasis is required on providing a safe environment for the children and clear, comprehendible warning of hazards on the label of the cyanoacrylate based-products.

NCT ID: NCT04040660 Available - Thermal Burn Clinical Trials

Use of NexoBrid for Treatment of Acute Deep Partial and Full Thickness Burn Injuries

NEXT
Start date: n/a
Phase:
Study type: Expanded Access

Enzymatic eschar removal with NexoBrid allows initiating and completing the phase of removal of the offending eschar earlier upon admission, enabling earlier visualization of the wound bed for assessment of burn wound depth as well as preservation of viable dermal tissues, as further elaborated and supported by previous clinical studies. The depth determination is important for the planning and execution of the post eschar removal stage of wound closure phase (grafting or spontaneous epithelialization). Additional clinically meaningful attributes of NexoBrid enzymatic eschar removal is the ability to lower surgical burden as it allows to remove eschar in wounds that otherwise would have to undergo surgical excision as no other non-surgical treatment is available for early and effective eschar removal. MediWound has completed the recruitment of patients to study MW2010-03-02 (DETECT Study). The timeline for patients' follow-up and potential for approval in 2021/2022, creates a significant gap in the ability of clinical practitioner's to maintain their knowledge and skills in using NexoBrid as they no longer treat eligible patients. The expanded access protocol will allow to expand treatment to additional patients in up to 30 US burn centers (DETECT sites and additional sites), until the completion of the BLA assessment and possible marketing authorization of NexoBrid in the US. The proposed protocol will allow product availability to eligible population and keep the clinical use of the product knowledge active in the burn care community introducing it to their routine burn care. The purpose of this treatment protocol is to provide NexoBrid to patients with DPT and FT thermal burns on up to 30% TBSA. This protocol is also designed to collect and evaluate the safety and clinical performance of NexoBrid in this patient population.

NCT ID: NCT03435172 Suspended - Thermal Burn Clinical Trials

Safety and Feasibility of ADRCs Treatment To Patients With Thermal Wounds

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

The primary objective of the protocol is to evaluate preliminary safety and feasibility of ADRCs via intravenous delivery in the treatment of deep partial and full thickness thermal wounds.