Wound HealNCT06108999
Management of Acute and Chronic Wounds With Hyaluronic Acid
A study testing Connettivina BIO cream and gauze in people with Wound Heal and Wound; Foot, run by Fidia Farmaceutici s.p.a. at 3 sites in Italy.
Trial summary
The purpose of this study is to evaluate the performance and safety of Connettivina Bio, when used in the management of wounds. Moreover, the study will evaluate the correlation of the 'dressing system' (formed by the Connettivina Bio primary dressing plus a secondary one) used in different care settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal, Wound; Foot
- What is being tested?
- Connettivina BIO cream and gauze
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 3 sitesItaly
- Study dates
- 29 Jul 2022to 30 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- Male or female ≥18 years.
- Patients selected to be treated with Connettivina Bio.
- Patients with wound of the following etiology: first and second degree burns; surgical wounds; vascular ulcers; metabolic ulcers; pressure ulcers.
- Patients followed on an outpatient or home basis.
- Wound area ≥ 10 cm2 and ≤ 100 cm2
Who cannot join
- Patients < 18 years.
- Patients with acute or chronic infected lesions.
- Hospitalized patients.
- Patients with acute or chronic lesions at high risk of infection, presenting at least one of the following criteria:
- Stalled wound, without any clinical sign of healing progression
- Immune system disorders
Show all 11Show fewer
- Protein-energy malnutrition
- Alcohol, smoking and drug abuse
- Conditions associated with hypoxia and/or poor tissue perfusion
- Corticosteroid, cytotoxic or immunosuppressive therapy.
- Subjects unable to understand informed consent or having a high probability of non-compliance with the study procedures and or non-completion of the study according to investigator's judgement.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
AOU Ospedali Riuniti SOD-Clinica di Chirurgia Plastica e Ricostruttiva
Ancona, 60127
Alessandro Scalise
- Not yet recruiting
Centro Grandi Ustionati OSPEDALE BUFALINI DI CESENA - (FC)
Cesena, Forlì-Cesena, 47521
Rossella Sgarzani
- Not yet recruiting
Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - SC (UCO)
Trieste, 34121
Luca Spazzapan
About this study
Official title: Prospective, Multicentric, Post-market Clinical Investigation to Evaluate the Performance and Safety of Connettivina Bio Line in Management of Acute and Chronic Wounds
The purpose of this study is to evaluate the performance and safety of Connettivina Bio, when used in the management of wounds. Moreover, the study will evaluate the correlation of the 'dressing system' (formed by the Connettivina Bio primary dressing plus a secondary one) used in different care settings. The study will include Italian healthcare facilities.
Read the detailed description
The primary objective of the prospective, multicentric, post-market clinical investigation is to evaluate the performance of Connettivina Bio (cream, gauze-pads) in the amelioration of wound bed appearance after 14 days of treatment. This objective will be assessed by measuring the percentage of patients showing, from baseline to 14 days of treatment, positive change in at least one of the following parameters: amelioration of wound tissue type (4=necrotic, 3=slough, 2=granulation tissue, 1=epithelial tissue, 0=closed), decrease of exudate amount (1=dry, 2=moist,3= slightly exuding, 4=heavily exuding, 5=wet) and amelioration of exudate type (1=bloody, 2=bloody/purulent, 3=clear, 4=murky,5= purulent, 6=serous). Furthermore, the secondary objectives of this clinical investigation include to define the Investigator's choice in clinical practice of Connettivina Bio (cream, gauze-pad) related to the clinical wound characteristics, the type of secondary dressing applied on the wound and the wound etiology, for this reason a descriptive analysis will be performed at baseline. Additionally, for the secondary objectives, the performance of Connettivina Bio (cream, gauze-pads) will be evaluated from baseline to 7, 21, 28, 42 and 56 days as amelioration of wound bed appearance in terms of type of wound bed tissue and exudate quantity and quality. To evaluate the improvement of quality of life of patients treated, the latter will be evaluated as a change from baseline to 56 days after the start of treatment, through administration of EuroQoL-5D (EQ-5D). Moreover, to evaluate the easiness of Connettivina Bio (cream, gauze-pads) application, the latter will be appraised by the clinician and by the patient after 56 days from the start of treatment as excellent, good, acceptable, bad or unacceptable. Finally, the safety and tolerability of Connettivina Bio (cream, gauze-pads) will be assessed throughout all the visits by investigating local and expected adverse events, as consequence of the product application and any other adverse event occurred during the study.
- Conditions
- Wound Heal, Wound; Foot
- Being tested
- Connettivina BIO cream and gauze
- Medical subject headings
- Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connettivina BIO cream and gauzeDevice
Connettivina Bio cream and gauze-pad efficacy and tolerability will be evaluated in the management of acute or chronic wounds of different etiology, according to instruction for use. Only one wound per patient will be considered for the treatment according to the study protocol. The schedule treatment will consist on a daily medication changes, according to the instruction for use and the clinical practice, for a maximum of 7 Visits.
| Study group | Role | What they receive |
|---|---|---|
| Connettivia BIO Cream | Experimental | All subjects will be treated with Connettivina BIO line (Cream or Gauze) Receives: Device: Connettivina BIO cream and gauze |
| Connettivina BIO Gauze | Experimental | All subjects will be treated with Connettivina BIO line (Cream or Gauze) Receives: Device: Connettivina BIO cream and gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the performance of Connettivina Bio line in the amelioration of wound bed appearance
The performance of Connettivina Bio line, in the amelioration of wound bed appearance, will be evaluated from baseline up to 14 days of treatment. The percentage of patients showing a change in at least of one of the following evaluated parameters: amelioration of wound tissue type (necrotic, slough, granulation tissue, epithelial tissue, closed), decrease of exudate amount (dry, moist, slightly exuding, heavily exuding, wet) and amelioration of exudate type (bloody, bloody/purulent, clear, murky, purulent, serous).
Measured: 14 days
Secondary outcomes (1)
Number of Participants With Treatment-Related Adverse Events
The safety and tolerability of Connettivina Bio will be assessed throughout all the visits by investigating local and expected adverse events, as a consequence of the product application. Additionally, any other adverse event occurred during the study will be considered and evaluated
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start29 Jul 2022
- Primary completion28 Feb 2024
- Study completion30 Sep 2024 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108999
- Sponsor's protocol ID
- AQ04-20-01
- Status last verified
- May 2024
- First submitted
- 16 Oct 2023
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentric, Post-market Clinical Investigation to Evaluate the Performance and Safety of Connettivina Bio Line in Management of Acute and Chronic Wounds
- ClinicalTrials.gov ID
- NCT06108999
- Acronym / sponsor ID
- AQ04-20-01
- Conditions
- Wound Heal, Wound; Foot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 31 Oct 2023 (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.
The purpose of this study is to evaluate the performance and safety of Connettivina Bio, when used in the management of wounds. Moreover, the study will evaluate the correlation of the 'dressing system' (formed by the Connettivina Bio primary dressing plus a secondary one) used in different care settings. The study will include Italian healthcare facilities.
Detailed description
The primary objective of the prospective, multicentric, post-market clinical investigation is to evaluate the performance of Connettivina Bio (cream, gauze-pads) in the amelioration of wound bed appearance after 14 days of treatment. This objective will be assessed by measuring the percentage of patients showing, from baseline to 14 days of treatment, positive change in at least one of the following parameters: amelioration of wound tissue type (4=necrotic, 3=slough, 2=granulation tissue, 1=epithelial tissue, 0=closed), decrease of exudate amount (1=dry, 2=moist,3= slightly exuding, 4=heavily exuding, 5=wet) and amelioration of exudate type (1=bloody, 2=bloody/purulent, 3=clear, 4=murky,5= purulent, 6=serous). Furthermore, the secondary objectives of this clinical investigation include to define the Investigator's choice in clinical practice of Connettivina Bio (cream, gauze-pad) related to the clinical wound characteristics, the type of secondary dressing applied on the wound and the wound etiology, for this reason a descriptive analysis will be performed at baseline. Additionally, for the secondary objectives, the performance of Connettivina Bio (cream, gauze-pads) will be evaluated from baseline to 7, 21, 28, 42 and 56 days as amelioration of wound bed appearance in terms of type of wound bed tissue and exudate quantity and quality. To evaluate the improvement of quality of life of patients treated, the latter will be evaluated as a change from baseline to 56 days after the start of treatment, through administration of EuroQoL-5D (EQ-5D). Moreover, to evaluate the easiness of Connettivina Bio (cream, gauze-pads) application, the latter will be appraised by the clinician and by the patient after 56 days from the start of treatment as excellent, good, acceptable, bad or unacceptable. Finally, the safety and tolerability of Connettivina Bio (cream, gauze-pads) will be assessed throughout all the visits by investigating local and expected adverse events, as consequence of the product application and any other adverse event occurred during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connettivia BIO Cream | Experimental | Device: Connettivina BIO cream and gauzeAll subjects will be treated with Connettivina BIO line (Cream or Gauze) |
| Connettivina BIO Gauze | Experimental | Device: Connettivina BIO cream and gauzeAll subjects will be treated with Connettivina BIO line (Cream or Gauze) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed written informed consent.
- Male or female ≥18 years.
- Patients selected to be treated with Connettivina Bio.
- Patients with wound of the following etiology: first and second degree burns; surgical wounds; vascular ulcers; metabolic ulcers; pressure ulcers.
- Patients followed on an outpatient or home basis.
Key exclusion criteria (11 listed)
- Patients < 18 years.
- Patients with acute or chronic infected lesions.
- Hospitalized patients.
- Patients with acute or chronic lesions at high risk of infection, presenting at least one of the following criteria:
- Subjects unable to understand informed consent or having a high probability of non-compliance with the study procedures and or non-completion of the study according to investigator's judgement.
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 |
|---|---|---|
| Connettivina BIO cream and gauzeConnettivina Bio cream and gauze-pad efficacy and tolerability will be evaluated in the management of acute or chronic wounds of different etiology, according to instruction for use. Only one wound per patient will be considered for the treatment according to the study protocol. The schedule treatment will consist on a daily medication changes, according to the instruction for use and the clinical practice, for a maximum of 7 Visits. | Device | Connettivia BIO Cream, Connettivina BIO Gauze |
Primary outcome
Evaluate the performance of Connettivina Bio line in the amelioration of wound bed appearance
Time frame: 14 days
The performance of Connettivina Bio line, in the amelioration of wound bed appearance, will be evaluated from baseline up to 14 days of treatment. The percentage of patients showing a change in at least of one of the following evaluated parameters: amelioration of wound tissue type (necrotic, slough, granulation tissue, epithelial tissue, closed), decrease of exudate amount (dry, moist, slightly exuding, heavily exuding, wet) and amelioration of exudate type (bloody, bloody/purulent, clear, murky, purulent, serous).
1 secondary outcome
Number of Participants With Treatment-Related Adverse Events
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connettivina BIO cream and gauze in people with Wound Heal and Wound; Foot, run by Fidia Farmaceutici s.p.a. at 3 sites 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 6 inclusion and 11 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 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Niocola Giordan (+39 349 823 2111, ngiordan@fidiapharma.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the performance of Connettivina Bio line in the amelioration of wound bed appearance (time frame: 14 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 9 May 2024.