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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: Argogen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects affected by pressure ulcers<br>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). | Device: Argogen<br>* Spray in short intervals, lightly pressing the dispenser button and pointing the spray on the area to be treated.<br>|
| Experimental: Subjects affected by burns<br>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). | Device: Argogen<br>* Spray in short intervals, lightly pressing the dispenser button and pointing the spray on the area to be treated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 - 4 weeks | 
| 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. | 2 - 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 - 4 weeks | 
| Time to healing evaluated by the Investigator | The investigator will assess the time of healing | 2 - 4 weeks | 
| 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. | 2 - 4 weeks | 
| 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. | 2 - 4 weeks | 
| 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 | 2 - 4 weeks | 
| 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 | 2 - 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Burn Wound, Minor Burn Wounds, Superficial Burn Wounds, Deep Partial thickness Burn Wounds, Pressure ulcers, pressure sores, bed sores, decubitus ulcers