Wound HealFPNCT04596124
Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze
A study testing fitostimoline plus in people with Wound Heal and Wound Infection, run by Farmaceutici Damor Spa at 1 site in Italy.
Trial summary
This study aims to compare the efficacy and clinical tolerability of two medical devices in gauze and cream containing the aqueous extract of triticum vulgare and polyhexanide in comparison with two medical devices containing hyaluronic acid and silver sulfadiazine in the treatment of acute skin lesions . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Wound Heal, Wound Infection, Wounds and Injuries
- What is being tested?
- fitostimoline plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteItaly
- Study dates
- 18 Sep 2020to 18 Sep 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Outpatient patients (regardless of sex) aged 18 and over;
- Presence of acute injury
- Willingness to cooperate and ability to understand the procedures and purposes of the study;
- Willingness to take part in the study and to adhere to the experimental procedures certified by signing the written informed consent
Who cannot join
- Pregnancy or breastfeeding;
- Inadequate contraceptive procedures in fertile women;
- Anamnestic data of any local and / or systemic pathology potentially able to interfere with the study parameters;
- Chronic concomitant treatment with local antiseptics, anti-inflammatory drugs (steroid and non-steroidal), analgesic, antineoplastic, immunosuppressive drugs;
- Immunodeficiency states (eg HIV infection); neoplastic diseases in progress;
- Non-therapeutic use of psychoactive substances;
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- Abuse of drugs and / or alcohol;
- Neurological disorders or psychiatric conditions that may affect the validity of the consent and / or compromise the patient's adherence to the study procedures;
- Allergy, hypersensitivity or intolerance known to the constituents of the preparations under study;
- Any condition, medical or otherwise, that could significantly reduce the possibility of obtaining reliable data, achieve the objectives of the study, refine the completion of this;
- Presumption of poor reliability or collaboration;
- Treatment with any investigational drug in the last 30 days prior to the start of the study;
- Patients already enrolled in this study;
- Center staff directly involved in the management of the study and close relatives of that.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Barbara Maglione
Monza, MB, 20900
barbara maglione, +393343293357 ext. +393343293357, barbara.maglione@farmadamor.it
About this study
Official title: Clincal Evaluation of the Effectiveness and Tolerability of Fitostimoline Plus Cream and Fitostimoline Plus Gauze vs Connettivina Bio Plus Cream and Connettivina Bio Plus Gauze in the Treatment of Acute Skin Lesions
This study aims to compare the efficacy and clinical tolerability of two medical devices in gauze and cream containing the aqueous extract of triticum vulgare and polyhexanide in comparison with two medical devices containing hyaluronic acid and silver sulfadiazine in the treatment of acute skin lesions . The reason why the two types of devices are compared is because hyaluronic acid and silver sulfadiazine represent the gold standard for the treatment of acute skin lesions. Therefore, making a comparison between the activity of the aqueous extract of triticum vulgare and polyhexanide and this gold standard of control in the treatment of acute skin lesions, is useful to better define the efficacy and tolerability of both medical devices in order to eventually expand the therapeutic armamentarium available for the treatment of acute skin lesions
Read the detailed description
Skin lesions, more or less deep, are areas of rupture and tissue loss with exposure of the underlying tissues.
The term "external lesion" or "wound" indicates the morphological and functional destruction of the continuity of the superficial skin layers and, in the most serious cases, of the deep subcutaneous layers.
The lesions are evaluated and cataloged on the basis of their width, depth and characteristics. Furthermore, the development, the causes (etiopathogenesis) and the pathophysiological context of the wound are considered.
Superficial, slight lesions affect only the epidermis, the dermis and at most part of the hypodermis; the deeper ones involve all the subcutaneous tissue (fat) up to the muscles, the periosteum, reaching the exposure of the bone or supporting structures (tendons and cartilages); the most severe (chronic) are characterized by loss of substance in the skin and a poor tendency to healing.
According to the timing of healing, the lesions are divided into acute and chronic.
Acute injuries heal through 3 different phases and reach tissue repair within 8/10 weeks. Beyond this time the lesion becomes chronic and, if not acted correctly, the wound becomes more complicated and degrades in increasingly serious stages / degrees.
The acute wounds that the healthcare professional must treat most frequently are surgical wounds. Depending on their extent, acute wounds can be distinguished into stab wounds, puncture wounds, lacerated wounds and lacerated-contused wounds.
This type of acute wounds can generally heal in a physiological way or be induced to healing through the use of dressings, which reduce healing times.
The main dressings used to treat these lesions are hyaluronic acid-based dressings containing antiseptics, such as silver sulphadiazine to prevent the risk of contamination and colonization by microorganisms. In these dressings, hyaluronic acid promotes the acceleration of the tissue repair process.
However, among the main products used by hospital and non-hospital surgeries there are also dressings based on Rigenase® (aqueous extract of triticum vulgare) and polyhexanide. Rigenase®, containing the aqueous extract of triticum vulgare, has pro-proliferative, anti-inflammatory and antioxidant activity. These activities are attested by recent literature which indicates that the aqueous extract of triticum vulgare has pro-proliferative activity on fibroblasts and keratinocytes, the main cells involved in proliferation during the lesion repair process; in addition, the aqueous extract of triticum vulgare also has a documented anti-inflammatory activity, mediated by the reduction of the main cytokines responsible for skin inflammation, and an anti-metalloprotease9 activity, the main actor of inflammation in skin lesions. The antioxidant activity of Rigenase®, verified on the hemolysis of erythrocytes, is comparable to that of ascorbic acid.
The activity of polyhexanide is also fundamental for the prevention of the risk of colonization and contamination by microorganisms in acute skin lesions. In fact, this latest generation antiseptic has a consolidated antiseptic activity on gram positive and gram negative bacteria, on fungi and on some viruses, without the development of resistance both in vitro and in vivo.
Based on the foregoing, this study aims to compare the efficacy and clinical tolerability of two medical devices in gauze and cream containing the aqueous extract of triticum vulgare and polyhexanide in comparison with two medical devices containing hyaluronic acid and silver sulfadiazine. in the treatment of acute skin lesions. The reason why the two types of devices are compared is because hyaluronic acid and silver sulfadiazine represent the gold standard for the treatment of acute skin lesions. Therefore, making a comparison between the activity of the aqueous extract of triticum vulgare and polyhexanide and this gold standard of control in the treatment of acute skin lesions, is useful to better define the efficacy and tolerability of both medical devices in order to to possibly expand the therapeutic armamentarium available for the treatment of acute skin lesions
- Conditions
- Wound Heal, Wound Infection, Wounds and Injuries
- Being tested
- fitostimoline plus
- Medical subject headings
- Wound Infection, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fitostimoline plusDevice
Also called connettivina bio plus
randomized controlled multicentric study
| Study group | Role | What they receive |
|---|---|---|
| fitostimoline plus cream | Experimental | Not described Receives: Device: fitostimoline plus |
| fitostimoline plus gauze | Experimental | Not described Receives: Device: fitostimoline plus |
| connettivina bio plus cream | Active comparator | Not described Receives: Device: fitostimoline plus |
| connettivina bio plus gauze | Active comparator | Not described Receives: Device: fitostimoline plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total symptom score
Total symptom score will be measured by a scale from 0 (absence of symptoms) to 4 (maximum intensity of symptoms).
Measured: 46 days
Secondary outcomes (1)
Visual Analog Scale
The visual analog scale will be evaluated for the presence of subjective acute and chronic pain. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: 46 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start18 Sep 2020
- Primary completion18 Aug 2022 (estimated)
- Study completion18 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled, multicentric study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Farmaceutici Damor Spa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, carmine alfano, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
- Investigators
- carmine alfano, Principal investigator, università di salerno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596124
- Sponsor's protocol ID
- Fitostimoline plus
- Acronym
- FP
- Status last verified
- Jul 2022
- First submitted
- 1 Oct 2020
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clincal Evaluation of the Effectiveness and Tolerability of Fitostimoline Plus Cream and Fitostimoline Plus Gauze vs Connettivina Bio Plus Cream and Connettivina Bio Plus Gauze in the Treatment of Acute Skin Lesions
- ClinicalTrials.gov ID
- NCT04596124
- Acronym / sponsor ID
- FP / Fitostimoline plus
- Conditions
- Wound Heal, Wound Infection, Wounds and Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Farmaceutici Damor SpaIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 18 Aug 2022 (estimated)
- Study completion
- 18 Sep 2022 (estimated)
- First posted
- 22 Oct 2020 (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.
This study aims to compare the efficacy and clinical tolerability of two medical devices in gauze and cream containing the aqueous extract of triticum vulgare and polyhexanide in comparison with two medical devices containing hyaluronic acid and silver sulfadiazine in the treatment of acute skin lesions . The reason why the two types of devices are compared is because hyaluronic acid and silver sulfadiazine represent the gold standard for the treatment of acute skin lesions. Therefore, making a comparison between the activity of the aqueous extract of triticum vulgare and polyhexanide and this gold standard of control in the treatment of acute skin lesions, is useful to better define the efficacy and tolerability of both medical devices in order to eventually expand the therapeutic armamentarium available for the treatment of acute skin lesions
Detailed description
Skin lesions, more or less deep, are areas of rupture and tissue loss with exposure of the underlying tissues.
The term "external lesion" or "wound" indicates the morphological and functional destruction of the continuity of the superficial skin layers and, in the most serious cases, of the deep subcutaneous layers.
The lesions are evaluated and cataloged on the basis of their width, depth and characteristics. Furthermore, the development, the causes (etiopathogenesis) and the pathophysiological context of the wound are considered.
Superficial, slight lesions affect only the epidermis, the dermis and at most part of the hypodermis; the deeper ones involve all the subcutaneous tissue (fat) up to the muscles, the periosteum, reaching the exposure of the bone or supporting structures (tendons and cartilages); the most severe (chronic) are characterized by loss of substance in the skin and a poor tendency to healing.
According to the timing of healing, the lesions are divided into acute and chronic.
Acute injuries heal through 3 different phases and reach tissue repair within 8/10 weeks. Beyond this time the lesion becomes chronic and, if not acted correctly, the wound becomes more complicated and degrades in increasingly serious stages / degrees.
The acute wounds that the healthcare professional must treat most frequently are surgical wounds. Depending on their extent, acute wounds can be distinguished into stab wounds, puncture wounds, lacerated wounds and lacerated-contused wounds.
This type of acute wounds can generally heal in a physiological way or be induced to healing through the use of dressings, which reduce healing times.
The main dressings used to treat these lesions are hyaluronic acid-based dressings containing antiseptics, such as silver sulphadiazine to prevent the risk of contamination and colonization by microorganisms. In these dressings, hyaluronic acid promotes the acceleration of the tissue repair process.
However, among the main products used by hospital and non-hospital surgeries there are also dressings based on Rigenase® (aqueous extract of triticum vulgare) and polyhexanide. Rigenase®, containing the aqueous extract of triticum vulgare, has pro-proliferative, anti-inflammatory and antioxidant activity. These activities are attested by recent literature which indicates that the aqueous extract of triticum vulgare has pro-proliferative activity on fibroblasts and keratinocytes, the main cells involved in proliferation during the lesion repair process; in addition, the aqueous extract of triticum vulgare also has a documented anti-inflammatory activity, mediated by the reduction of the main cytokines responsible for skin inflammation, and an anti-metalloprotease9 activity, the main actor of inflammation in skin lesions. The antioxidant activity of Rigenase®, verified on the hemolysis of erythrocytes, is comparable to that of ascorbic acid.
The activity of polyhexanide is also fundamental for the prevention of the risk of colonization and contamination by microorganisms in acute skin lesions. In fact, this latest generation antiseptic has a consolidated antiseptic activity on gram positive and gram negative bacteria, on fungi and on some viruses, without the development of resistance both in vitro and in vivo.
Based on the foregoing, this study aims to compare the efficacy and clinical tolerability of two medical devices in gauze and cream containing the aqueous extract of triticum vulgare and polyhexanide in comparison with two medical devices containing hyaluronic acid and silver sulfadiazine. in the treatment of acute skin lesions. The reason why the two types of devices are compared is because hyaluronic acid and silver sulfadiazine represent the gold standard for the treatment of acute skin lesions. Therefore, making a comparison between the activity of the aqueous extract of triticum vulgare and polyhexanide and this gold standard of control in the treatment of acute skin lesions, is useful to better define the efficacy and tolerability of both medical devices in order to to possibly expand the therapeutic armamentarium available for the treatment of acute skin lesions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- randomized, controlled, multicentric study
| Arm | Type | Receives |
|---|---|---|
| fitostimoline plus cream | Experimental | Device: fitostimoline plus |
| fitostimoline plus gauze | Experimental | Device: fitostimoline plus |
| connettivina bio plus cream | Active comparator | Device: fitostimoline plus |
| connettivina bio plus gauze | Active comparator | Device: fitostimoline plus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatient patients (regardless of sex) aged 18 and over;
- Presence of acute injury
- Willingness to cooperate and ability to understand the procedures and purposes of the study;
- Willingness to take part in the study and to adhere to the experimental procedures certified by signing the written informed consent
Key exclusion criteria (14 listed)
- Pregnancy or breastfeeding;
- Inadequate contraceptive procedures in fertile women;
- Anamnestic data of any local and / or systemic pathology potentially able to interfere with the study parameters;
- Chronic concomitant treatment with local antiseptics, anti-inflammatory drugs (steroid and non-steroidal), analgesic, antineoplastic, immunosuppressive drugs;
- Immunodeficiency states (eg HIV infection); neoplastic diseases in progress;
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 |
|---|---|---|
| fitostimoline plusAlso: connettivina bio plusrandomized controlled multicentric study | Device | connettivina bio plus cream, connettivina bio plus gauze, fitostimoline plus cream, fitostimoline plus gauze |
Primary outcome
Total symptom score
Time frame: 46 days
Total symptom score will be measured by a scale from 0 (absence of symptoms) to 4 (maximum intensity of symptoms).
1 secondary outcome
Visual Analog Scale
Time frame: 46 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: No
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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.
carmine alfano principal investigator
università di salerno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fitostimoline plus in people with Wound Heal and Wound Infection, run by Farmaceutici Damor Spa at 1 site in Italy.
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 14 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: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact barbara maglione (+393343293357 ext. +393343293357, barbara.maglione@farmadamor.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total symptom score (time frame: 46 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2022.