Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05649332
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-25
First Post:
2022-11-16
Brief Title:
Study to Evaluate the Performance and Safety of the Medical Device Argogen
Sponsor:
Signorini Medicale Srl
Organization:
Signorini Medicale Srl
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A wound ie 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 andor 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None