MedTrace Logo

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

NCT05649332 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-12-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • Signorini Medicale S.r.l.

    lead INDUSTRY

Principal Investigators

  • Lorel Muresan, PhD · SC Salvosan Ciobanca SRL

  • Simona L Ianosi, PhD · MC Medica SRL

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-21
Primary Completion
2023-12-06
Completion
2023-12-06

Countries

  • Romania

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05649332 on ClinicalTrials.gov