Burn WoundNCT05649332
Study to Evaluate the Performance and Safety of the Medical Device Argogen
A study testing Argogen (silver zeolite powder) in people with Burn Wound and Pressure Ulcers Stage II, run by Signorini Medicale S.r.l. at 2 sites in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Burn Wound, Pressure Ulcers Stage II, Pressure Ulcers Stage III
- What is being tested?
- Argogen (silver zeolite powder)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesRomania
- Study dates
- 21 Apr 2023to 6 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Romania2 sites
MC Medica SRL
Craiova, Dolj, 200061
SC Salvosan Ciobanca SRL
Zalău, Sălaj County, 450117
About this study
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
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.
Read more
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.
- Being tested
- Argogen (silver zeolite powder)
- Keywords
- Burn Wound, Minor Burn Wounds, Superficial Burn Wounds, Deep Partial thickness Burn Wounds, Pressure ulcers, pressure sores, bed sores, decubitus ulcers
- Medical subject headings
- Burns, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argogen (silver zeolite powder)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects presenting pressure ulcers or burn wounds | Experimental | Subjects will be treated with the medical device Argogen® adsorbing spray powder. The dosage will depend on the patient's skin condition and the extent of the areas to be treated. The medical device will be used twice a day without interruption for the duration of the study (4 weeks) or until complete healing. Receives: Device: Argogen (silver zeolite powder) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 - 4 weeks
Secondary outcomes (6)
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.
Measured: 2 - 4 weeks
Time to healing evaluated by the Investigator
The investigator will assess the time of healing
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 2 - 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start21 Apr 2023
- Primary completion6 Dec 2023
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Burn WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Signorini Medicale S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
- Investigators
- Lorel Muresan, PhD, Principal investigator, SC Salvosan Ciobanca SRLSimona L Ianosi, PhD, Principal investigator, MC Medica SRL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649332
- Sponsor's protocol ID
- Signorini Medicale S.r.l.
- Status last verified
- Nov 2024
- First submitted
- 16 Nov 2022
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sood A, Granick MS, Tomaselli NL. Wound Dressings and Comparative Effectiveness Data. Adv Wound Care (New Rochelle). 2014 Aug 1;3(8):511-529. doi: 10.1089/wound.2012.0401.
PubMed 25126472Edsberg LE, Black JM, Goldberg M, McNichol L, Moore L, Sieggreen M. Revised National Pressure Ulcer Advisory Panel Pressure Injury Staging System: Revised Pressure Injury Staging System. J Wound Ostomy Continence Nurs. 2016 Nov/Dec;43(6):585-597. doi: 10.1097/WON.0000000000000281.
PubMed 27749790Abazari M, Ghaffari A, Rashidzadeh H, Badeleh SM, Maleki Y. A Systematic Review on Classification, Identification, and Healing Process of Burn Wound Healing. Int J Low Extrem Wounds. 2022 Mar;21(1):18-30. doi: 10.1177/1534734620924857. Epub 2020 Jun 11.
PubMed 32524874Kagan RJ, Peck MD, Ahrenholz DH, Hickerson WL, Holmes J 4th, Korentager R, Kraatz J, Pollock K, Kotoski G. Surgical management of the burn wound and use of skin substitutes: an expert panel white paper. J Burn Care Res. 2013 Mar-Apr;34(2):e60-79. doi: 10.1097/BCR.0b013e31827039a6. No abstract available.
PubMed 23446645Fan K, Tang J, Escandon J, Kirsner RS. State of the art in topical wound-healing products. Plast Reconstr Surg. 2011 Jan;127 Suppl 1:44S-59S. doi: 10.1097/PRS.0b013e3181fbe275.
PubMed 21200273Atiyeh BS, Costagliola M, Hayek SN, Dibo SA. Effect of silver on burn wound infection control and healing: review of the literature. Burns. 2007 Mar;33(2):139-48. doi: 10.1016/j.burns.2006.06.010. Epub 2006 Nov 29.
PubMed 17137719Cavanagh MH, Burrell RE, Nadworny PL. Evaluating antimicrobial efficacy of new commercially available silver dressings. Int Wound J. 2010 Oct;7(5):394-405. doi: 10.1111/j.1742-481X.2010.00705.x.
PubMed 20626470Wright JB, Lam K, Hansen D, Burrell RE. Efficacy of topical silver against fungal burn wound pathogens. Am J Infect Control. 1999 Aug;27(4):344-50. doi: 10.1016/s0196-6553(99)70055-6.
PubMed 10433674Matsumura Y, Yoshikata K, Kunisaki S, Tsuchido T. Mode of bactericidal action of silver zeolite and its comparison with that of silver nitrate. Appl Environ Microbiol. 2003 Jul;69(7):4278-81. doi: 10.1128/AEM.69.7.4278-4281.2003.
PubMed 12839814Kwakye-Awuah B, Williams C, Kenward MA, Radecka I. Antimicrobial action and efficiency of silver-loaded zeolite X. J Appl Microbiol. 2008 May;104(5):1516-24. doi: 10.1111/j.1365-2672.2007.03673.x. Epub 2007 Dec 20.
PubMed 18179543Saeidinia A, Keihanian F, Lashkari AP, Lahiji HG, Mobayyen M, Heidarzade A, Golchai J. Partial-thickness burn wounds healing by topical treatment: A randomized controlled comparison between silver sulfadiazine and centiderm. Medicine (Baltimore). 2017 Mar;96(9):e6168. doi: 10.1097/MD.0000000000006168.
PubMed 28248871Passaglia E. Zeoliti naturali, zeolititi e loro applicazioni [Internet]. [cited 2022 Jun 27]. Available from: https://www.unilibro.it/libro/passaglia-elio/zeoliti-naturali-zeolititi-loro-applicazioni/9788887801194
Rai M, Yadav A, Gade A. Silver nanoparticles as a new generation of antimicrobials. Biotechnol Adv. 2009 Jan-Feb;27(1):76-83. doi: 10.1016/j.biotechadv.2008.09.002. Epub 2008 Sep 30.
PubMed 18854209Tsipouras N, Rix CJ, Brady PH. Passage of silver ions through membrane-mimetic materials, and its relevance to treatment of burn wounds with silver sulfadiazine cream. Clin Chem. 1997 Feb;43(2):290-301.
PubMed 9023132Burd A, Kwok CH, Hung SC, Chan HS, Gu H, Lam WK, Huang L. A comparative study of the cytotoxicity of silver-based dressings in monolayer cell, tissue explant, and animal models. Wound Repair Regen. 2007 Jan-Feb;15(1):94-104. doi: 10.1111/j.1524-475X.2006.00190.x.
PubMed 17244325
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05649332
- Acronym / sponsor ID
- Signorini Medicale S.r.l.
- Keywords
- Burn Wound, Minor Burn Wounds, Superficial Burn Wounds, Deep Partial thickness Burn Wounds, Pressure ulcers, pressure sores, bed sores, decubitus ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Signorini Medicale S.r.l.Industry (pharma, biotech, devices)
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects presenting pressure ulcers or burn wounds | Experimental | Device: Argogen (silver zeolite powder)Subjects will be treated with the medical device Argogen® adsorbing spray powder. The dosage will depend on the patient's skin condition and the extent of the areas to be treated. The medical device will be used twice a day without interruption for the duration of the study (4 weeks) or until complete healing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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).*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Subjects presenting pressure ulcers or burn wounds |
Primary outcome
To evaluate the overall performance of Argogen spray® in safely promoting wound healing according to following evaluations
Time frame: 2 - 4 weeks
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
Time frame: 2 - 4 weeks
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.
6 secondary outcomes
Assessment of wound bed, wound edge, periwound skin status, performed by the Investigator
Time frame: 2 - 4 weeks
Time to healing evaluated by the Investigator
Time frame: 2 - 4 weeks
Pain assessment assessed by the Subject
Time frame: 2 - 4 weeks
To assess the subject satisfaction with the treatment
Time frame: 2 - 4 weeks
To evaluate the global performance of Argogen
Time frame: 2 - 4 weeks
To evaluate the global safety of Argogen
Time frame: 2 - 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Background: PubMed 25126472Sood A, Granick MS, Tomaselli NL. Wound Dressings and Comparative Effectiveness Data. Adv Wound Care (New Rochelle). 2014 Aug 1;3(8):511-529. doi: 10.1089/wound.2012.0401.
- Background: PubMed 27749790Edsberg LE, Black JM, Goldberg M, McNichol L, Moore L, Sieggreen M. Revised National Pressure Ulcer Advisory Panel Pressure Injury Staging System: Revised Pressure Injury Staging System. J Wound Ostomy Continence Nurs. 2016 Nov/Dec;43(6):585-597. doi: 10.1097/WON.0000000000000281.
- Background: PubMed 32524874Abazari M, Ghaffari A, Rashidzadeh H, Badeleh SM, Maleki Y. A Systematic Review on Classification, Identification, and Healing Process of Burn Wound Healing. Int J Low Extrem Wounds. 2022 Mar;21(1):18-30. doi: 10.1177/1534734620924857. Epub 2020 Jun 11.
- Background: PubMed 23446645Kagan RJ, Peck MD, Ahrenholz DH, Hickerson WL, Holmes J 4th, Korentager R, Kraatz J, Pollock K, Kotoski G. Surgical management of the burn wound and use of skin substitutes: an expert panel white paper. J Burn Care Res. 2013 Mar-Apr;34(2):e60-79. doi: 10.1097/BCR.0b013e31827039a6. No abstract available.
- Background: PubMed 21200273Fan K, Tang J, Escandon J, Kirsner RS. State of the art in topical wound-healing products. Plast Reconstr Surg. 2011 Jan;127 Suppl 1:44S-59S. doi: 10.1097/PRS.0b013e3181fbe275.
- Background: PubMed 17137719Atiyeh BS, Costagliola M, Hayek SN, Dibo SA. Effect of silver on burn wound infection control and healing: review of the literature. Burns. 2007 Mar;33(2):139-48. doi: 10.1016/j.burns.2006.06.010. Epub 2006 Nov 29.
- Background: PubMed 20626470Cavanagh MH, Burrell RE, Nadworny PL. Evaluating antimicrobial efficacy of new commercially available silver dressings. Int Wound J. 2010 Oct;7(5):394-405. doi: 10.1111/j.1742-481X.2010.00705.x.
- Background: PubMed 10433674Wright JB, Lam K, Hansen D, Burrell RE. Efficacy of topical silver against fungal burn wound pathogens. Am J Infect Control. 1999 Aug;27(4):344-50. doi: 10.1016/s0196-6553(99)70055-6.
- Background: PubMed 12839814Matsumura Y, Yoshikata K, Kunisaki S, Tsuchido T. Mode of bactericidal action of silver zeolite and its comparison with that of silver nitrate. Appl Environ Microbiol. 2003 Jul;69(7):4278-81. doi: 10.1128/AEM.69.7.4278-4281.2003.
- Background: PubMed 18179543Kwakye-Awuah B, Williams C, Kenward MA, Radecka I. Antimicrobial action and efficiency of silver-loaded zeolite X. J Appl Microbiol. 2008 May;104(5):1516-24. doi: 10.1111/j.1365-2672.2007.03673.x. Epub 2007 Dec 20.
- Background: PubMed 28248871Saeidinia A, Keihanian F, Lashkari AP, Lahiji HG, Mobayyen M, Heidarzade A, Golchai J. Partial-thickness burn wounds healing by topical treatment: A randomized controlled comparison between silver sulfadiazine and centiderm. Medicine (Baltimore). 2017 Mar;96(9):e6168. doi: 10.1097/MD.0000000000006168.
- BackgroundPassaglia E. Zeoliti naturali, zeolititi e loro applicazioni [Internet]. [cited 2022 Jun 27]. Available from: https://www.unilibro.it/libro/passaglia-elio/zeoliti-naturali-zeolititi-loro-applicazioni/9788887801194
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorel Muresan, PhD principal investigator
SC Salvosan Ciobanca SRL
Simona L Ianosi, PhD principal investigator
MC Medica SRL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Argogen (silver zeolite powder) in people with Burn Wound and Pressure Ulcers Stage II, run by Signorini Medicale S.r.l. at 2 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the overall performance of Argogen spray® in safely promoting wound healing according to following evaluations (time frame: 2 - 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05649332, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.