Jun 01, 2026
Version 2
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. V.2
- Dionisio Franco Barattini1,
- Carlo Signorini2
- 1Opera CRO a Tigermed company, Timisoara (Romania);
- 2QA Department, Signorini Medicale S.r.l.,Albaredo d’Adige (Italy)
- Barattini
Protocol Citation: Dionisio Franco Barattini, Carlo Signorini 2026. 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 a. protocols.io https://dx.doi.org/10.17504/protocols.io.81wgbmdpnvpk/v2Version created by Dionisio Franco Barattini
License: This is an open access protocol distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited
Protocol status: Working
We use this protocol and it's working
Created: May 30, 2026
Last Modified: June 01, 2026
Protocol Integer ID: 318232
Keywords: treatment of pressure ulcer, moderate pressure ulcer, pressure ulcer, iii pressure ulcer, administered argogen, safety of the medical device argogen, safety profile of argogen, medical device argogen, treatment of pressure, spray powder for exudate, ionic silver, adsorbing spray powder, argogen, silver ion, spray powder, treatment, tested product, treatment of mild, developed medical device
Funders Acknowledgements:
Signorini Medicale S.r.l. (Italy)
Grant ID: No ID number
Abstract
This study will test Argogen, a recently developed medical device produced by Signorini Medicale S.r.l. in Italy. Argogen is an adsorbing spray powder that combines ionic silver (2.5%) and micronized zeolite (97.5%) for the treatment of pressure ulcers and minor first- and second-degree burns. This Post-Market Clinical Follow-Up (PMCF) study has an open, non-comparative design. A total of 68 outpatients will be included: 34 with chronic stage II–III pressure ulcers (NPUAP) that have not healed after at least three weeks of standard care, and 34 with superficial/partial-thickness burns covering less than 10% of the body surface area. Patients will be administered Argogen within 48 hours of enrolment and will use it for four weeks. The co-primary endpoints are changes in the PUSH score for pressure ulcers and the Vancouver Scar Scale score for burns after four weeks. The secondary endpoints are pain on a 100 mm visual analogue scale, patient satisfaction, investigator global assessment of performance and safety. The expected outcome of this real-world study is confirmation of the performance and safety profile of Argogen in the treatment of mild-to-moderate pressure ulcers and minor burns. Additionally, the tested product could demonstrate its ease of use and ability to support outpatient self-management.
Attachments
Guidelines
- ICH Harmonized Tripartite guidelines for Good Clinical Practice (ICH GCP) requirements.
- Local Romanian legislation on medical devices.
- Medical Devices guidelines (MEDDEV and MDCG)
- ISO 14155: 2020
- MDR 2017/745
Safety warnings
This protocol is according to ISO 14155:2020.
Any and all information here presented will remain the exclusive property of SIGNORINI MEDICALE S.r.l.
Ethics statement
The protocol was approved on March 9, 2023 by the National Ethics Committees (Comisia Naţională de Bioetică a Medicamentului şi a Dispozitivelor Medicale, Romania) under the number 28DM. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki. Written informed consent was obtained from every participant prior to enrollment.
General Informations
| A | B | |
| Study code | OPSIG/0122/MD | |
| Version | 1.0 (final) - 25/07/2022 | |
| Registry | ClinicalTrials.gov ID: NCT05649332 | |
| Phase | Post-Market Clinical Follow-Up (PMCF) study | |
| MD Class | Medical Device of Class III, according to the classification rules of Annex IX of Medical Device Directive 93/42/EEC (Rule 13). Already CE marked. | |
| Sponsor | SIGNORINI MEDICALE Srl Via Dell'Artigianato, 14 37041 Albaredo D'Adige (VR) - Italy | |
| CRO | Opera CRO Strada Cozia N.10, 300209 Timisoara - Romania | |
| Study Design | Open, prospective, non-comparative, multicentre, interventional PMCF study | |
| Coordinator Site | Dr Lorel Mureșan SC Salvosan Ciobanca SRL Strada Dumbrava N.48, Zalău - Romania | |
| Satellite Site | Dr Laura Simona Ianoși MC Medica SRL 99, Boulevard Carol I N.99, Craiova - Romania |
Introduction and Rationale
The skin is the largest organ of the human body, and it primarily serves as protective barrier against the environment. A wound, i.e., a break in the skin, can result from several reasons.
Pressure ulcers (also called pressure sores, bed soresand decubitus ulcers)are localized damageto the skin and underlying soft tissue usuallyover a bony prominence or related to a medicalor 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. Wound of any origin undergo a process of healing, intended as the physiological processes aimed to repair and restore damaged skin tissue. Healing involves a complex series of molecular, cellular, and chemical changes that result in inflammation, proliferation, granulation, re-modelling and re- epithelialisation. To optimise healing is fundamental to control microbial contamination and maintaining a moist environment; appropriate dressings can help. The Medical Device Argogen (adsorbing spray powder for exudates with silver ions) consists of silver zeolite powder, combiningin a single physical form the adsorbingproperties 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. Following the PMCF requirements the Research Question of 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 observedafter 2 and 4 weeks after the beginning of the treatment
Objectives
The primary objectives of the study are to evaluate the overall performance and safety of Argogen in safely promoting wound healing according to the evaluations detailed in sub-sections 3.1.
The secondary objectives are evaluations of the global performance and safety of Argogen as detailed in sub-sections 3.2.
Primary performance objectives
- In pressure ulcer performance treatment is assessed by the Pressure Ulcer Scale for Healing (PUSH) score after 4 weeks of treatment .
or
- In burn wounds performance treatment is assessed by the Vancouver Scar Scale (VSS) after 4 weeks of treatment
Primary safety objectives
- To evaluate global safety, the incidence of AEs, SAEs, ADE, SADE, ASADE, and USADE are assessed by the investigator and reported according to current legislation.
Secondary performance objectives
- In pressure ulcer performance treatment is assessed by the PUSH score after 2 weeks of treatment .
or
- In burn wounds performance treatment is assessed by the VSS after 2 weeks of treatment
- Time to healing
- Pain assessment (VAS)
- Treatment satisfaction questionnaire
- Investigator Global Assessment of Performance (IGAP).
Secondary safety objectives
- To evaluate the global safety by means of the Investigator / Patient Global Assessment of Safety (IGAS and PGAS) assessed by the Investigator and by the patient.
Endpoints
The performance endpoints of the study are the percentage (%) of subjects with objective signs of wound healing, evaluated by Investigator , according to subsection 4.1 and 4.2.
The safety endpoints used in the study are reported in the subsections 4.3 and 4.4.
Endpoints
Primary performance endpoints
- for pressure ulcers: evaluation of PUSH ver. 3.0 score (according to evaluation of the 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).
or
- for burns wounds: evaluation of burn wound VSS score (according to evaluation of the parameters: vascularity, height/thickness, pliability and pigmentation), performed by the Investigator at 4 weeks after the initiation of treatment, compared to day 0 (baseline).
Secondary performance endpoints
- for pressure ulcers: evaluation of PUSH ver. 3.0 score, performed by the Investigator at 2 weeks after the initiation of treatment, compared to day 0 (baseline).
or
- for burn wounds: evaluation of burn wound VSS score, performed by the Investigator at 2 weeks after the initiation of treatment, compared to day 0 (baseline).
- Time to healing evaluated by the Investigator that will stop the administration of the tested device (from week 2 to week 4)
- Pain assessment (100 mm – Visual Analogue Scale - VAS) assessed by the patientat 2 and 4 weeks after the initiation of treatment, compared to day 0 (baseline).
- Treatment satisfaction questionnaire, assessed by the patient, at 4 weeks, compared to day 0 (baseline).
- Investigator Global Assessment of Performance (IGAP), through photos taken at each visit, assessed by the Investigator at 4 weeks, compared to day 0 (baseline).
Primary safety endpoints
- AEs, SAEs, ADE, SADE, ASADE, and USADE incidence during the 28 days of study duration
Secondary safety endpoints
- Investigator Global Assessment of Safety (IGAS), assessed by the Investigator, at 4 weeks, compared to day 0 (baseline)
- Patient Global Assessment of Safety (PGAS), assessed by the patient, at 4 weeks, compared to day 0 (baseline).
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 treatedwithin 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 (hormonal contraceptive, intrauterine device or intrauterine system, double barrier method (condom with spermicide/diaphragm or cervical cap with spermicide), surgical sterilization).
- 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 hospitalization during the study.
- Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
Study duration for each patient
Four weeks
Sample size
Sixty-eight enrollable patients will be needed, at approximately 10% drop-out rate (68 enrolled; 62 evaluable).
- 34 patients affected by pressure ulcers(34 patients enrolled,31 evaluable)
- 34 patients affected by burns (34 patients enrolled, 31 evaluable).
When calculating the sample size, the following parameters were chosen: ·
Type I error – alpha:0.025 (correction for multiplicity for multiple outcomes)·
Type II error – beta: 0.2 (Power: 0.8)
A high effect size: 0.6
Drop-out rate of around 10%.
The sample size is 31 evaluable subjects for each medical condition. The test used in this calculation is Wilcoxon signed-rank test assessing the change in PUSH, respectively VSS score from baseline to final visit.
Not allowed concomitant treatment
The simultaneous administration of Argogen and local proteolytic enzymes or concomitant administration of products containing proteolytic enzymes (i.e., bromelain, chymotrypsin, ficin, papain, serrapeptase, trypsin) can cause the deactivation of the latter due to the presence of silver ions. Therefore, such an association should be avoided. Any other drug or treatment mentioned in the eligibility criteria as not allowed will be forbidden during the study and the use will be avoided by patients, otherwise they will be excluded from the study.
Investigational Medical Device (IMD)
Argogen (adsorbing spray powder for exudates with silver ions) is intended for topical external use to treat skin lesions and wounds of different origin,when an absorption of exudates is needed, such as burn wounds, pressure ulcers (such as pressure sores, bed sores and decubitus ulcers), abrasions. It consists of a mineral spray white powder with absorbent characteristics, containing 2.5% ionic silver. It helps control exudates and creates a clean environment to facilitate the natural healing process, while keeping the area protected from the proliferation of bacteria. The exudates absorption action is due to micronized zeolite, a silicate mineral powder with a porous structure and high absorption capacity; in addition, the device contains ionic silver with an ancillary antimicrobial function. Argogen is packaged in aerosol aluminium spray can, and contains the following ingredients: silver zeolite powder, composed by zeolite micronized (97.5%) and ionic silver (Ag+, 2.5%), and n-butane (as propellant).
IMD Active administration
Argogen will be used for 4 weeks. All patients will use Argogen for the treatment of minor burn wounds or pressure ulcers. The IMD (dose and posology) will be used according to the current Instruction For Use (IFU): twice a day from day 0 to week 2. If requested by Investigators Argogen administration can be continued for additional 2 weeks until day 28 (final visit). It is recommended not to use the product for more than 4 weeks. The patients will be generally treated with IMD at home. If inpatient is required by the Investigators, the subjects will be treated in hospital. All affected body areas will be treated, however only the mainly affected area (target wound, as specified in the CRF, for each patient) will be considered for the evaluation of the endpoints.
Chronogram of visits
The study envisages the following visitsper patient:
Visit 1, day 0: Screening / Baseline visit (1st administration of the IMD)
Visit 2, week 1 (± 1 day): interim visit
Visit 3, week 2 (± 1 day): interim visit
Visit 4, week 4 (± 2 days): End of the Study visit
Statistical analysis
The principle of intention-to-treat (ITT),as far as practically possible,will be the main strategy of the
analysis adopted for the primary endpoint and all the secondary endpoints. These analyses will be conducted on all participants. No imputations will be made on missing data. The statistical plan details the following 3 analysis sets ITT, Per-Protocol, Safety populations. The protocol outlines that a two-sided p-value of 0.05 or less will be used to declare statistical significance for all analyses. Similarly, all confidence intervals will be calculated at the 95% level. No adjustment for multiplicity will be made to adjust type 1 error rate for secondary endpoints. If necessary, relevant results from other studies already reported in the literature will be considered in the interpretation of results. The final analysis will be completed after all patients have been exited the study, all queries resolved, and the database have been locked. If a patient is missing information for one or more variables, the missing data will not be replaced. Quantitative variables (i.e.,demographic) if normally distributed will be described through mean and standard deviation (SD); variables non-normally distributed will be described using median and range of interquartile. The Student's t-test for paired data and the Wilcoxon signed rank test will be employed to perform comparative analysis in accordance with the distribution of these variables. Categorical variables will be described using frequencies and percentages and comparative analysis will use the χ2 test or Fisher’s exact test. Additionally, AN(C)OVA for repeated measures and/or Linear Mixed Models analysis will be performed to assess the secondary endpoints. Considering this clinical trial’s design as a longitudinal cohort study, the focus of the performed statistical assessments will be the longitudinal (statistical) analysis. Primary endpoint, percentage (%) of subjects with objective signs of wound healing at 4 weeks visit, will be analysed by performing a Student’s t-test for paired data, or a Wilcoxon signed rank test if major deviations from former’s test assumptions are recorded. As no missing data imputation on the primary outcome is planned, if such cases arise, a Linear Mixed Model analysis will be performed, to make use of the complete ITT population. Secondary endpoints, all continuous variables in nature, will be assessed by performing ANOVA for repeated measures tests, or ANCOVA for repeated measures tests (if considering covariates like age, sex, BMI, etc.), assuming completeness of data (no missing data). If missingness of data drastically reduces the sample size (e.g., > 5% of patients will be eliminated), a robust statistical analysis method will be employed instead. Such a method, Linear Mixed Models analysis, has the main advantage of making use of the complete ITT population. The safety analysis will be done on the ITT population. Minor deviation from the original statistical plan (SAP) will be considered acceptable (e.g., due to non-parametrical form of the data, statistical tests will be adjusted accordingly). Major deviations from the SAP will be reported by the statistician to the Clinical Project Manager and will result in Clinical Investigational Plan amendments.
Tables will include baseline characteristics of the participants, medical history and concomitant medications, and safety outcomes. A CONSORT diagram illustrating the flow of patients through the study is also planned. Additional details about statistical analysis will be documented in the Statistical Analysis Plan (SAP), enclosed to the Trial Master File.
GCP Statement, Guidelines and legislation
The Clinical Investigation Plan of the present study has been developed in accordance with the
following:
- ICH Harmonized Tripartite guidelines for Good Clinical Practice (ICH GCP) requirements.
- Local Romanian legislation on medical devices.
- Medical Devices guidelines (MEDDEV and MDCG)
- ISO 14155: 2020
- MDR 2017/745
Observation and Assessments Schedule
* In order to fully evaluate the exclusion criteria a blood sample collection could be
necessary, unless the following parameters have been tested (and a copy of the
lab test is available) in the 3 months before inclusion in this clinical investigation:
Platelet
Haemoglobin
Protocol references
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Acknowledgements
Marius Ardelean (Tigermed, Romania) for the statistical analysis,