Superficial Cutaneous LesionsNCT04652752
Clinical Investigation to Evaluate the Safety and Efficacy of Dressing CONNETTIVINA HI TECH in the Management of Superficial Cutaneous Lesions
A study testing CONNETTIVINA HI TECH patch in people with Superficial Cutaneous Lesions, run by Fidia Farmaceutici s.p.a. at 1 site in Italy.
Trial summary
This is an open, single arm, prospective clinical investigation to evaluate the performance of CONNETTIVINA HI TECH, in terms of safety and efficacy in the management of superficial cutaneous lesions. The study will be conducted in one center, in Italy and will enroll 50 subjects . Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Superficial Cutaneous Lesions
- What is being tested?
- CONNETTIVINA HI TECH patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 12 Oct 2019to 30 Dec 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 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent.
- Male or female ≥ 18 and ≤ 85 years
- Having a superficial cutaneous lesion of different etiology, with the following characteristics:
- Wound bed appearance of grade ≥15 of WBS (Wound Bed Score: Falanga 2006) Absence of clinical signs or symptoms of local infection (as defined by CDC/NHSN) Size: between 5 and 32 cm2 that can be covered by a dressing of 4x8cm
- In case of multiple lesions per patient, only one lesion will be considered for the treatment (the better choice for self-evaluation of lesion by patient)
- Patient able to maintain a Patient's Diary during the study
- Patient able to read and understand the language and content of the study material, understand the requirements for follow-up visits, is willing to provide information at the scheduled evaluations and is willing and able to comply with the study requirements
- Ensured compliance of subjects for the study period
Who cannot join
- Patients who not sign the informed consent form
- Patients with non-superficial wounds exposing bones, tendon or muscle bundles.
- Patients with WBS score under or equal to 14 ("severe exudate amount", or "moderate exudate amount" and "moderate per-wound dermatitis" or "moderate callous peri-wound")
- Presence of signs of infection as defined by CDC/NHMS
- History of connective tissue disease, e.g., systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease
- Uncontrolled congestive heart failure
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- Active malignant disease
- Active sickle cell disease
- Patients who are immunocompromised for reasons such as therapy with corticosteroids, chemotherapy, antiangiogenic or immunosuppressive agents, or due to immunodeficiency syndromes
- Known allergy to any of the devices' constituents
- Women who are pregnant, breastfeeding or who have not reached menopause and are not abstinent or practicing an acceptable means of birth control as determined by the Investigator for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open, Clinical Trial to Evaluate the Safety and Efficacy of Dressing CONNETTIVINA HI TECH in the Management of Superficial Cutaneous Lesions
This is an open, single arm, prospective clinical investigation to evaluate the performance of CONNETTIVINA HI TECH, in terms of safety and efficacy in the management of superficial cutaneous lesions. The study will be conducted in one center, in Italy and will enroll 50 subjects . Subjects will be followed until confirmation of complete wound closure, and for a maximum of 26 days, with a follow up of 4 days after re-epithelization will be confirmed.
- Conditions
- Superficial Cutaneous Lesions
- Being tested
- CONNETTIVINA HI TECH patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONNETTIVINA HI TECH patchDevice
It is a medical device for topical application in the form of a patch with adhesive transparent polyurethane edge and a central pad impregnated with a solution of hyaluronic acid sodium salt, able to create a hydrating environment, such as to favor the natural healing process of tissue repair in case of bruises, abrasions, small cuts, superficial wounds, burns
| Study group | Role | What they receive |
|---|---|---|
| CONNETTIVINA HI TECH patch | Experimental | CONNETTIVINA HI TECH patch will be applied to eligible patients. CONNETTIVINA HI TECH will be renewed every two day, according with general principles of wound management Receives: Device: CONNETTIVINA HI TECH patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dimentions of lesion in patients compared to baseline
Change from of superficial cutaneous lesions by measuring the area of the superficial lesion after 14 days of treatment
Measured: at 14 days
Secondary outcomes (5)
Healing rate as a difference in the mean percentage reduction of lesion area from baseline in patients treated with CONNETTIVINA HI TECH
The healing rate will be evaluated at all time points as a difference in the mean percentage reduction of lesion area from baseline measured by a wound imaging device
Measured: at 2,8, 14, 20 and 26 days
Patient's satisfaction with CONNETTIVINA HI TECH
Patient's satisfaction with CONNETTIVINA HI TECH will be evaluated at each post baseline visit: patients will assess their degrees of satisfaction with the use of the dressing by the means of a 5 grade scale
Measured: at 2,8, 14, 20 and 26 days
Clinician's global assessment of the lesion (CGA)
Clinical Global Assessment (CGA) will be evaluated at each post baseline visit: the clinician will be requested to score the lesion on a five grade scale
Measured: at 2,8, 14, 20 and 26 days
Evaluation of dressing Adhesion
Evaluation of dressing adhesion evaluated at each visit by considering the effective frequency of dressing change and comparing it with the frequency indicated by the clinical investigation plan
Measured: at day 28
Number of Participants With Treatment-Related Adverse Events
The safety and tolerability of treatments will be assessed by investigating local and expected adverse events, as consequence of the product application and any other adverse event occurred during the study.
Measured: at 2,8, 14, 20 and 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start12 Oct 2019
- Primary completion31 Mar 2022
- Study completion30 Dec 2022
Why it stopped: Enrollment Difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial Cutaneous LesionsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
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
- NCT04652752
- Sponsor's protocol ID
- AQ04-19-01
- Status last verified
- Oct 2023
- First submitted
- 2 Mar 2020
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Clinical Trial to Evaluate the Safety and Efficacy of Dressing CONNETTIVINA HI TECH in the Management of Superficial Cutaneous Lesions
- ClinicalTrials.gov ID
- NCT04652752
- Acronym / sponsor ID
- AQ04-19-01
- Conditions
- Superficial Cutaneous Lesions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment Difficulties
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 3 Dec 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 is an open, single arm, prospective clinical investigation to evaluate the performance of CONNETTIVINA HI TECH, in terms of safety and efficacy in the management of superficial cutaneous lesions. The study will be conducted in one center, in Italy and will enroll 50 subjects . Subjects will be followed until confirmation of complete wound closure, and for a maximum of 26 days, with a follow up of 4 days after re-epithelization will be confirmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CONNETTIVINA HI TECH patch | Experimental | Device: CONNETTIVINA HI TECH patchCONNETTIVINA HI TECH patch will be applied to eligible patients. CONNETTIVINA HI TECH will be renewed every two day, according with general principles of wound management |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed written informed consent.
- Male or female ≥ 18 and ≤ 85 years
- Having a superficial cutaneous lesion of different etiology, with the following characteristics:
- Wound bed appearance of grade ≥15 of WBS (Wound Bed Score: Falanga 2006) Absence of clinical signs or symptoms of local infection (as defined by CDC/NHSN) Size: between 5 and 32 cm2 that can be covered by a dressing of 4x8cm
- In case of multiple lesions per patient, only one lesion will be considered for the treatment (the better choice for self-evaluation of lesion by patient)
Key exclusion criteria (11 listed)
- Patients who not sign the informed consent form
- Patients with non-superficial wounds exposing bones, tendon or muscle bundles.
- Patients with WBS score under or equal to 14 ("severe exudate amount", or "moderate exudate amount" and "moderate per-wound dermatitis" or "moderate callous peri-wound")
- Presence of signs of infection as defined by CDC/NHMS
- History of connective tissue disease, e.g., systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease
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 HI TECH patchIt is a medical device for topical application in the form of a patch with adhesive transparent polyurethane edge and a central pad impregnated with a solution of hyaluronic acid sodium salt, able to create a hydrating environment, such as to favor the natural healing process of tissue repair in case of bruises, abrasions, small cuts, superficial wounds, burns | Device | CONNETTIVINA HI TECH patch |
Primary outcome
Change in dimentions of lesion in patients compared to baseline
Time frame: at 14 days
Change from of superficial cutaneous lesions by measuring the area of the superficial lesion after 14 days of treatment
5 secondary outcomes
Healing rate as a difference in the mean percentage reduction of lesion area from baseline in patients treated with CONNETTIVINA HI TECH
Time frame: at 2,8, 14, 20 and 26 days
Patient's satisfaction with CONNETTIVINA HI TECH
Time frame: at 2,8, 14, 20 and 26 days
Clinician's global assessment of the lesion (CGA)
Time frame: at 2,8, 14, 20 and 26 days
Evaluation of dressing Adhesion
Time frame: at day 28
Number of Participants With Treatment-Related Adverse Events
Time frame: at 2,8, 14, 20 and 26 days
Results and safety
The study was stopped early (reason given: Enrollment Difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONNETTIVINA HI TECH patch in people with Superficial Cutaneous Lesions, run by Fidia Farmaceutici s.p.a. 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 8 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: stopped early, as of the sponsor's last update on 18 Oct 2023. 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?
The study was stopped early (reason given: Enrollment Difficulties). Results are not available in the source record.
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?
Change in dimentions of lesion in patients compared to baseline (time frame: at 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 18 Oct 2023.