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

Primary Purpose

Burn Wound, Pressure Ulcers Stage II, Pressure Ulcers Stage III

Status
Not yet recruiting
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Argogen
Sponsored by
Signorini Medicale S.r.l.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn Wound focused on measuring Burn Wound, Minor Burn Wounds, Superficial Burn Wounds, Deep Partial thickness Burn Wounds, Pressure ulcers, pressure sores, bed sores, decubitus ulcers

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: In- or outpatients of both sexes, of all ethnic backgrounds, aged between 18 and 75 years(inclusive). Patients presenting superficial / first degree and superficial / deep partial-thickness / second degree burn wound in less than 10% of total body surface area, for which the burning event occurred within 48 hours and that can be treated within 24 hours after enrolment in the study (at baseline) or patients presenting chronic pressure ulcers stage 2 or 3 (according to the NPUAP Classification) that did not heal within 3 weeks despite proper wound care, with areas (or scattered areas) of necrosis (nonviable soft tissue/slough) more than 40%, and with a target wound which is between 4 cm squared to 20 cm squared in area at the baseline assessment. Patients, who are, in the opinion of the Investigator, able to understand this study, cooperate with the study procedures and are willing to return to the centre (if outpatients) for all the required visits. Patients who have given their written informed consent in accordance with provisions of pertinent excerpt from the Declaration of Helsinki and the Romanian laws. Exclusion Criteria: Severe heart (myocardial infarction, myocardial damage, etc.), brain, liver, kidney, lung and other organ disease. Medical history or not-treated diabetes mellitus or diabetic foot syndrome. Peripheral artery disease with ankle brachial index (ABI < 0.9). Thrombocytopenic patients (platelet <150.000 g/l; collected in last 3 months medical history).* Haemoglobin < 95 g/l (collected in last 3 months medical history).* Concomitant infection of another site or osteomyelitis or erysipelas or phlegmon. Complicated deep tissue infection requiring systemic antimicrobial therapy. Active viral hepatitis (A/B/C) or active HIV infection or active syphilis. Presence of neoplastic growth in the ulcer. History or clinical signs of impairment of the cochlea or vestibularis system. Neuromuscular diseases (i.e., myasthenia gravis, Parkinson's disease) Aminoglycoside treatment or other antibiotic treatments for chronic venous ulcers administered less than four weeks before inclusion. Concomitant administration of proteolytic enzymes or products containing proteolytic enzymes (i.e., bromelain, chymotrypsin, ficin, papain, serrapeptase, trypsin) during the whole study. Pregnant woman, lactating woman, and man or woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception** during the study. **Methods of contraception: hormonal contraceptive, intrauterine device or intrauterine system, double barrier method (condom with spermicide/diaphragm or cervical cap with spermicide), surgical sterilization (vasectomy, tubal ligation, etc.). Known allergy to the tested medical device and its components (in particular, allergy to silver). Patients with any other medical condition that, in the opinion of the Investigator, would compromise participation or be likely to lead to hospitalisation during the study. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days. If such lab tests are not available at screening a blood sample can be collected for analyses. However, the patient can be enrolled and start immediately treatment. After Visit 1, the Investigator will examine the laboratory results, as soon as available, to determine patient continuation.

Sites / Locations

  • MC Medica SRL
  • SC Salvosan Ciobanca SRL

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Subjects affected by pressure ulcers

Subjects affected by burns

Arm Description

Percentage of subjects whose wounds condition is improved during the four-week treatment with the medical device evaluated by Investigator, according to the pressure ulcers evaluation of PUSH ver. 3.0 score (according to evaluation of the following parameters: length times width, exudate amount and tissue type), performed by the Investigator at 4 weeks after the initiation of treatment, compared to day 0 (baseline).

Percentage of subjects whose wounds condition is improved during the four-week treatment with the medical device evaluated by Investigator, according to the evaluation of burn wound VSS score (according to evaluation of the following parameters: vascularity, height/thickness, pliability and pigmentation), performed by the Investigator at 4 weeks after the initiation of treatment, compared to day 0 (baseline).

Outcomes

Primary Outcome Measures

To evaluate the overall performance of Argogen spray® in safely promoting wound healing according to following evaluations
of pressure ulcers: percentage of subjects with objective signs of wound healing, assessed through the validated Pressure Ulcer Scale for Healing tool (PUSH ver. 3.0score) evaluated by Investigator and burn wounds: percentage (%) of subjects with objective signs of wound healing, assessed through the validated Vancouver Scar Scale (VSS), evaluated by Investigator.
To evaluate the overall safety of Argogen spray® in safely promoting wound healing according to following evaluations
Adverse Events, Serious Adverse Events, Adverse Device Events, Serious Adverse Device Events, Anticipated Serious Adverse Device Events, Unanticipated Serious Adverse Device Events incidence assessed by Investigator and reported according to the current legislation.

Secondary Outcome Measures

Assessment of wound bed, wound edge, periwound skin status, performed by the Investigator
Assessment of wound bed, wound edge, periwound skin status, performed by the Investigator at 2 and 4 weeks after the initiation of treatment, compared to day 0 (baseline), based on skin appearance. The lower the percentage and affected surface - cm, the better evolution of healing compared to baseline.
Time to healing evaluated by the Investigator
The investigator will assess the time of healing
Pain assessment assessed by the Subject
Evaluation of pain due to burn wound or pressure ulcer will be done according to a Visual Analogue Scale. The rating will be made on 100 mm line/scale in which 0 is meaning no pain and 100 is meaning very severe pain. The subject has to place a vertical mark on a 100mm line to indicate how bad does he/she feels the pain at the moment of completing the questionnaire.
To assess the subject satisfaction with the treatment
The subject will assess the satisfaction with the treatment by means of the treatment satisfaction questionnaire using the four-point scale in which the subject has to place an "X" mark in the box that fits with his/ her situation: Very Satisfied, Satisfied, Moderately satisfied, Not satisfied.
To evaluate the global performance of Argogen
To evaluate the global performance of Argogen® by means of the Investigator Global Assessment of Performance, assessed by Investigator, through photos taken at each visit and by the performance of the treatment questionnaire using a 4-point scale: 1= very good performance 2 = good performance 3 = moderate performance 4 = poor performance
To evaluate the global safety of Argogen
To evaluate the global safety of Argogen® by means of the Investigator / Patient Global Assessment of Safety assessed by the Investigator and by the patient using a 4-point scale: 1= very good safety 2 = good safety 3 = moderate safety 4 = poor safety

Full Information

First Posted
November 16, 2022
Last Updated
April 21, 2023
Sponsor
Signorini Medicale S.r.l.
Collaborators
Opera CRO, a TIGERMED Group Company
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1. Study Identification

Unique Protocol Identification Number
NCT05649332
Brief Title
Study to Evaluate the Performance and Safety of the Medical Device Argogen
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
September 7, 2023 (Anticipated)
Study Completion Date
September 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Signorini Medicale S.r.l.
Collaborators
Opera CRO, a TIGERMED Group Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Wound, Pressure Ulcers Stage II, Pressure Ulcers Stage III
Keywords
Burn Wound, Minor Burn Wounds, Superficial Burn Wounds, Deep Partial thickness Burn Wounds, Pressure ulcers, pressure sores, bed sores, decubitus ulcers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Subjects affected by pressure ulcers
Arm Type
Experimental
Arm Description
Percentage of subjects whose wounds condition is improved during the four-week treatment with the medical device evaluated by Investigator, according to the pressure ulcers evaluation of PUSH ver. 3.0 score (according to evaluation of the following parameters: length times width, exudate amount and tissue type), performed by the Investigator at 4 weeks after the initiation of treatment, compared to day 0 (baseline).
Arm Title
Subjects affected by burns
Arm Type
Experimental
Arm Description
Percentage of subjects whose wounds condition is improved during the four-week treatment with the medical device evaluated by Investigator, according to the evaluation of burn wound VSS score (according to evaluation of the following parameters: vascularity, height/thickness, pliability and pigmentation), performed by the Investigator at 4 weeks after the initiation of treatment, compared to day 0 (baseline).
Intervention Type
Device
Intervention Name(s)
Argogen
Intervention Description
Spray in short intervals, lightly pressing the dispenser button and pointing the spray on the area to be treated.
Primary Outcome Measure Information:
Title
To evaluate the overall performance of Argogen spray® in safely promoting wound healing according to following evaluations
Description
of pressure ulcers: percentage of subjects with objective signs of wound healing, assessed through the validated Pressure Ulcer Scale for Healing tool (PUSH ver. 3.0score) evaluated by Investigator and burn wounds: percentage (%) of subjects with objective signs of wound healing, assessed through the validated Vancouver Scar Scale (VSS), evaluated by Investigator.
Time Frame
2 - 4 weeks
Title
To evaluate the overall safety of Argogen spray® in safely promoting wound healing according to following evaluations
Description
Adverse Events, Serious Adverse Events, Adverse Device Events, Serious Adverse Device Events, Anticipated Serious Adverse Device Events, Unanticipated Serious Adverse Device Events incidence assessed by Investigator and reported according to the current legislation.
Time Frame
2 - 4 weeks
Secondary Outcome Measure Information:
Title
Assessment of wound bed, wound edge, periwound skin status, performed by the Investigator
Description
Assessment of wound bed, wound edge, periwound skin status, performed by the Investigator at 2 and 4 weeks after the initiation of treatment, compared to day 0 (baseline), based on skin appearance. The lower the percentage and affected surface - cm, the better evolution of healing compared to baseline.
Time Frame
2 - 4 weeks
Title
Time to healing evaluated by the Investigator
Description
The investigator will assess the time of healing
Time Frame
2 - 4 weeks
Title
Pain assessment assessed by the Subject
Description
Evaluation of pain due to burn wound or pressure ulcer will be done according to a Visual Analogue Scale. The rating will be made on 100 mm line/scale in which 0 is meaning no pain and 100 is meaning very severe pain. The subject has to place a vertical mark on a 100mm line to indicate how bad does he/she feels the pain at the moment of completing the questionnaire.
Time Frame
2 - 4 weeks
Title
To assess the subject satisfaction with the treatment
Description
The subject will assess the satisfaction with the treatment by means of the treatment satisfaction questionnaire using the four-point scale in which the subject has to place an "X" mark in the box that fits with his/ her situation: Very Satisfied, Satisfied, Moderately satisfied, Not satisfied.
Time Frame
2 - 4 weeks
Title
To evaluate the global performance of Argogen
Description
To evaluate the global performance of Argogen® by means of the Investigator Global Assessment of Performance, assessed by Investigator, through photos taken at each visit and by the performance of the treatment questionnaire using a 4-point scale: 1= very good performance 2 = good performance 3 = moderate performance 4 = poor performance
Time Frame
2 - 4 weeks
Title
To evaluate the global safety of Argogen
Description
To evaluate the global safety of Argogen® by means of the Investigator / Patient Global Assessment of Safety assessed by the Investigator and by the patient using a 4-point scale: 1= very good safety 2 = good safety 3 = moderate safety 4 = poor safety
Time Frame
2 - 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In- or outpatients of both sexes, of all ethnic backgrounds, aged between 18 and 75 years(inclusive). Patients presenting superficial / first degree and superficial / deep partial-thickness / second degree burn wound in less than 10% of total body surface area, for which the burning event occurred within 48 hours and that can be treated within 24 hours after enrolment in the study (at baseline) or patients presenting chronic pressure ulcers stage 2 or 3 (according to the NPUAP Classification) that did not heal within 3 weeks despite proper wound care, with areas (or scattered areas) of necrosis (nonviable soft tissue/slough) more than 40%, and with a target wound which is between 4 cm squared to 20 cm squared in area at the baseline assessment. Patients, who are, in the opinion of the Investigator, able to understand this study, cooperate with the study procedures and are willing to return to the centre (if outpatients) for all the required visits. Patients who have given their written informed consent in accordance with provisions of pertinent excerpt from the Declaration of Helsinki and the Romanian laws. Exclusion Criteria: Severe heart (myocardial infarction, myocardial damage, etc.), brain, liver, kidney, lung and other organ disease. Medical history or not-treated diabetes mellitus or diabetic foot syndrome. Peripheral artery disease with ankle brachial index (ABI < 0.9). Thrombocytopenic patients (platelet <150.000 g/l; collected in last 3 months medical history).* Haemoglobin < 95 g/l (collected in last 3 months medical history).* Concomitant infection of another site or osteomyelitis or erysipelas or phlegmon. Complicated deep tissue infection requiring systemic antimicrobial therapy. Active viral hepatitis (A/B/C) or active HIV infection or active syphilis. Presence of neoplastic growth in the ulcer. History or clinical signs of impairment of the cochlea or vestibularis system. Neuromuscular diseases (i.e., myasthenia gravis, Parkinson's disease) Aminoglycoside treatment or other antibiotic treatments for chronic venous ulcers administered less than four weeks before inclusion. Concomitant administration of proteolytic enzymes or products containing proteolytic enzymes (i.e., bromelain, chymotrypsin, ficin, papain, serrapeptase, trypsin) during the whole study. Pregnant woman, lactating woman, and man or woman of childbearing potential who is planning a pregnancy or is unwilling to use appropriate methods of contraception** during the study. **Methods of contraception: hormonal contraceptive, intrauterine device or intrauterine system, double barrier method (condom with spermicide/diaphragm or cervical cap with spermicide), surgical sterilization (vasectomy, tubal ligation, etc.). Known allergy to the tested medical device and its components (in particular, allergy to silver). Patients with any other medical condition that, in the opinion of the Investigator, would compromise participation or be likely to lead to hospitalisation during the study. Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days. If such lab tests are not available at screening a blood sample can be collected for analyses. However, the patient can be enrolled and start immediately treatment. After Visit 1, the Investigator will examine the laboratory results, as soon as available, to determine patient continuation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dionisio F Barattini, MD
Phone
+40774012684
Email
franco.barattini@tigermedgrp.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sanja Moga, PharmD
Phone
+40 723 636 037
Email
sanja.moga@tigermedgrp.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorel Muresan, PhD
Organizational Affiliation
SC Salvosan Ciobanca SRL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simona L Ianosi, PhD
Organizational Affiliation
MC Medica SRL
Official's Role
Principal Investigator
Facility Information:
Facility Name
MC Medica SRL
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200061
Country
Romania
Facility Name
SC Salvosan Ciobanca SRL
City
Zalau
State/Province
Salaj
ZIP/Postal Code
450117
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorel Muresan, PhD

12. IPD Sharing Statement

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

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