NCT05649332

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

Open, Non-comparative, Multicentre, Interventional Post-market Clinical Follow-up (PMCF) Study to Evaluate the Performance and Safety of the Medical Device Argogen® (adsorbing Spray Powder for Exudates with Silver Ions) in the Treatment of Pressure Ulcers and Minor (first and Second Degree) Burn Wounds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Signorini Medicale S.r.l. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Burn Wound
• Pressure Ulcers Stage II
• Pressure Ulcers Stage III

Interventions

Type	Name	Description
DEVICE	Argogen (silver zeolite powder)	The medical device will be self-administered by each patient twice daily without interruption for the duration of the study (4 weeks) or until complete healing. Application is carried out by spraying at short intervals, lightly pressing the dispenser button and directing the spray onto the area to be treated.

Timeline

• Start date: 2023-04-21
• Primary completion: 2023-12-06
• Completion: 2023-12-06
• First posted: 2022-12-14
• Last updated: 2024-12-03

Locations

2 sites across 1 country: Romania