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Burn Wound clinical trials

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NCT ID: NCT05649332 Not yet recruiting - Burn Wound Clinical Trials

Study to Evaluate the Performance and Safety of the Medical Device Argogen

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

A wound, i.e., a break in the skin, can result from several reasons. Pressure ulcers (also called pressure sores, bed sores and decubitus ulcers) are localized damage to the skin and underlying soft tissue usually over a bony prominence or related to a medical or other device, occurring as a result of intense and/or prolonged pressure or pressure in combination with shear. Burn wounds result from traumatic injuries to the skin or other tissues primarily caused by heat, electrical discharge, friction, chemicals, or radiation. Burns are acute wounds caused by an isolated, non-recurring insult. The Medical Device Argogen® (adsorbing spray powder for exudates with silver ions) consists of silver zeolite powder, combining in a single physical form the adsorbing properties of the zeolite structure and the antimicrobial properties of silver. Its action is due to the porous structure of zeolite that actively absorbs and control wounds exudate, keeping clean and dry the environment of small skin lesions, as wounds, abrasions, minor burns and bedsores. The association with silver ions gives to the medical device the additional property of an antimicrobial effect. The present study is to confirm that in a population of men and women presenting minor burn wounds (superficial or superficial / deep partial thickness) or chronic pressure ulcers stage 2 or 3 - NPUAP Classification (partial-thickness skin loss with exposed dermis or full-thickness skin loss) the medical device already CE marked Argogen® (adsorbing spray powder for exudates with silver ions) safely attests its capacity to promote wound healing, evaluated as percentage (%) of subjects with objective signs of wound healing (evaluated by mean of VSS score reduction for burn wounds or PUSH tool score reduction for pressure ulcers), results observed after 2 and 4 weeks after the beginning of the treatment.

NCT ID: NCT04011306 Not yet recruiting - Burn Wound Clinical Trials

A Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns

Start date: February 2020
Phase: N/A
Study type: Interventional

The primary purpose of this feasibility study is to evaluate safety and effectiveness in healing outcomes of patients treated with Lumina24TM BLU (treatment), a Continuous Low-Irradiance Phototherapy (CLIP) device, as compared to standard of care (SOC) therapy (control) for the treatment of acute burns.