WoundsNCT04936204
Clinical Investigation to Evaluate the Safety and Performance of ConnettivinaBio Plus Cream Compared to ConnettivinaBio Cream in the Management of Wounds in Patients at High Risk of Infection
A study testing ConnettivinaBio Plus cream and ConnettivinaBio cream in people with Wounds, run by Fidia Farmaceutici s.p.a. at 1 site in Italy.
Trial summary
The clinical investigation plan will include a Screening/Baseline visit (V1) in which patients will be screened on the basis of inclusion/exclusion criteria and clinically evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds
- What is being tested?
- ConnettivinaBio Plus cream and ConnettivinaBio cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jun 2021to Dec 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
- Having wounds (both chronic or acute wounds regardless of etiology), with the following characteristics:
- Non infected
- Wound Bed Score ≥4 and <13
- Wound area ≤ 100 cm2
- Patient having one or more factors associated with increased risk of wound infection (IWII, 2016)
- 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, able and ensuring to comply with the study requirements for the whole study period.
Who cannot join
- Absence of factors associated with increased risk of wound infection
- Infected wounds - where infection is defined by:
- For chronic wounds:
- A combination of three or more signs or symptoms of local infection: periwound skin erythema, local heat, persistent pain, oedema of wound.s edge, malodour, pus and heavy exudation (Cutting KF, 1994; Trial C, 2010);
- For acute wounds:
- Cellulitis or pus or abscess, Delayed healing, erythema, hardening of edge, serous-purulent drainage, malodour
Show all 16Show fewer
- Non-vital tissue greater than 25% of the total wound area
- Heavily exuding wounds
- Presence of fistula
- History of connective tissue disease, e.g., systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease
- Active malignant disease
- Active sickle cell disease
- radiation therapy
- Known allergy to any of the devices' constituents
- Pregnant and breastfeeding women
- 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
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Casa di Cura Villa Donatello
Florence
Luca Gazzabin, MD, gazzabinluca@gmail.com
About this study
Official title: A Prospective, Randomized, Controlled, Single-blind Clinical Investigation to Evaluate the Safety and Performance of ConnettivinaBio Plus Cream Compared to ConnettivinaBio Cream in the Management of Wounds in Patients at High Risk of Infection
The clinical investigation plan will include a Screening/Baseline visit (V1) in which patients will be screened on the basis of inclusion/exclusion criteria and clinically evaluated. Screened and eligible patients will be randomly assigned in one of the two groups: Group 1 will receive ConnettivinaBio Plus cream whereas Group 2 will receive ConnettivinaBio cream. Lesions will be cleaned and a photo will be acquired with a digital camera.
In both groups, the schedule treatment will consist of daily medication changes.
Wound Bed Score, clinical signs of localized infection, measurement of the wound area, collection of the swab, according to the Levine's technique, EQ-5D questionnaire to the patient will be assessed on Day 1 (V1, baseline visit), 7 (V2), 14 (V3), 21 (V4) and 28 (V5) post-baseline. Treatments in both groups (ConnettivinaBio Plus or ConnettivinaBio) will be applied for a maximum period of 28 days. The easiness of treatment application will be also recorded at V5.
- Conditions
- Wounds
- Being tested
- ConnettivinaBio Plus cream, ConnettivinaBio cream
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConnettivinaBio Plus creamDevice
Also called Bionect Plus, Hyalo4 Control
The Un-blinded Investigator will perform the first application of medication. He will also instruct the patient or his/her caregiver to the self-application of the treatment which will be covered by a secondary dressing according to the site's standard care.
ConnettivinaBio creamDevice
Also called Bionect, Hyalo4 skin
The Un-blinded Investigator will perform the first application of medication. He will also instruct the patient or his/her caregiver to the self-application of the treatment which will be covered by a secondary dressing according to the site's standard care.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 ConnettivinaBio Plus cream | Experimental | ConnettivinaBio Plus cream is a topical preparation constituted by Principal component: Hyaluronic acid sodium salt 0.2% Other components: Silver Sulfadiazine 1%, The medication should be applied once a day as a thin layer to cover the entire surface of the wound previously cleansed Receives: Device: ConnettivinaBio Plus cream |
| Group 2 ConnettivinaBio cream | Active comparator | ConnettivinaBio Cream is a topical preparation constituted by Principal component: Hyaluronic acid sodium salt 0.2% The medication should be applied once a day as a thin layer to cover the entire surface of the wound previously cleansed Receives: Device: ConnettivinaBio cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
improving the wounds bed conditions in wounds at high risk of infection, after 14 days of treatment, compared to ConnettivinaBio cream
The amelioration of wound's bed conditions will be evaluated by measuring the proportion of patients having an increase of at least one subclass of the Wound Bed Score (WBS) (0-16 score; 0 worse score-16 best score possible) (Falanga V, 2006) from baseline to 14 days of treatment with ConnettivinaBio Plus cream compared to ConnettivinaBio cream.
Measured: at day 14
Secondary outcomes (9)
improving the wound bed condition
The amelioration of the wound bed conditions will be evaluated:
- by measuring the proportion of patients having an increase of at least one subclass of the WBS (0-16 score; 0 worse score-16 best score possible) from baseline to 7, 21 and 28 days of treatment with ConnettivinaBio Plus cream compared to ConnettivinaBio cream;
Measured: At days 7, 21 and 28
improving the wound bed condition
The amelioration of the wound bed conditions will be evaluated:
- by measuring the percentage change from baseline in the WBS (0-16 score; 0 worse score-16 best score possible) after 7, 14, 21, and 28 days of treatment with ConnettivinaBio Plus cream compared to ConnettivinaBio cream.
Measured: At days 7, 14, 21 and 28
control of bacterial load of wounds
The performance of ConnettivinaBio Plus in the bacterial load control will be evaluated by measuring the change from baseline of CFU/ml derived from the culture of a swab collected according to the Levin's technique, after 7, 14 and 28 days of treatment and compared to ConnettivinaBio cream
Measured: At days 7, 14, 21 and 28
control on signs of wound infection
Difference in the performance of ConnettivinaBio Plus, compared to ConnettivinaBio, with respect to clinical signs of wound infection. The appearance and/or modification of signs of infection will be evaluated as percentage change from baseline at all visits. The evaluation will be carried out calculating the clinical wound's infection score through an 18-point scale, based on the presence and intensity of the following clinical signs: fever, local heat, peri-lesional erythema, persistent pain (between two dressing changes), oedema, malodour, pus and exudate production (Cutting KF, 1994; Trial C, 2010).
Measured: At days 7, 14, 21 and 28
improving the reepithelization rate
The reepithelization rate will be evaluated as the difference in the mean percentage reduction of lesion area from baseline between patients treated with ConnettivinaBio Plus versus ConnettivinaBio at all the visits by using a computerized image software (Chang AC, 2011) and as a distribution of percentage reduction in the following classes: ≤25%; >25% and ≤50%; >50% and ≤75%; >75% and ≤95%; >95% and ≤100% of the lesion area.
Measured: At days 7, 21 and 28
improving patient's quality of life
Patient's quality of life assessment will be evaluated as a change from baseline after 7, 14, 21 and 28 days, through administration of EuroQoL-5D (EQ-5D)
Measured: At days 7, 14, 21 and 28
clinician's global assessment of the lesion
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: 1= worsening, 2= no change, 3= minimal improvement, 4= moderate improvement and 5= good improvement
Measured: At days 7, 14, 21 and 28
easiness of the treatment application
The easiness of the treatment application will be appraised by the Un-blinded Investigator and by the patient after 28 days as excellent, good, acceptable, bad or unacceptable.
Measured: at day 28
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The safety and tolerability of treatment 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: throughout study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start10 Jun 2021
- Primary completionApr 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies 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
- A prospective, randomized, controlled, single-blind clinical investigation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 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
- NCT04936204
- Sponsor's protocol ID
- HQQ2-19-01
- Status last verified
- Oct 2023
- First submitted
- 7 Oct 2020
- Last updated
- 18 Oct 2023
- 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 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Single-blind Clinical Investigation to Evaluate the Safety and Performance of ConnettivinaBio Plus Cream Compared to ConnettivinaBio Cream in the Management of Wounds in Patients at High Risk of Infection
- ClinicalTrials.gov ID
- NCT04936204
- Acronym / sponsor ID
- HQQ2-19-01
- Conditions
- Wounds
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Jun 2021 (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 clinical investigation plan will include a Screening/Baseline visit (V1) in which patients will be screened on the basis of inclusion/exclusion criteria and clinically evaluated. Screened and eligible patients will be randomly assigned in one of the two groups: Group 1 will receive ConnettivinaBio Plus cream whereas Group 2 will receive ConnettivinaBio cream. Lesions will be cleaned and a photo will be acquired with a digital camera.
In both groups, the schedule treatment will consist of daily medication changes.
Wound Bed Score, clinical signs of localized infection, measurement of the wound area, collection of the swab, according to the Levine's technique, EQ-5D questionnaire to the patient will be assessed on Day 1 (V1, baseline visit), 7 (V2), 14 (V3), 21 (V4) and 28 (V5) post-baseline. Treatments in both groups (ConnettivinaBio Plus or ConnettivinaBio) will be applied for a maximum period of 28 days. The easiness of treatment application will be also recorded at V5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, randomized, controlled, single-blind clinical investigation
| Arm | Type | Receives |
|---|---|---|
| Group 1 ConnettivinaBio Plus cream | Experimental | Device: ConnettivinaBio Plus creamConnettivinaBio Plus cream is a topical preparation constituted by Principal component: Hyaluronic acid sodium salt 0.2% Other components: Silver Sulfadiazine 1%, The medication should be applied once a day as a thin layer to cover the entire surface of the wound previously cleansed |
| Group 2 ConnettivinaBio cream | Active comparator | Device: ConnettivinaBio creamConnettivinaBio Cream is a topical preparation constituted by Principal component: Hyaluronic acid sodium salt 0.2% The medication should be applied once a day as a thin layer to cover the entire surface of the wound previously cleansed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed written informed consent.
- Male or female ≥ 18 years
- Having wounds (both chronic or acute wounds regardless of etiology), with the following characteristics:
- Non infected
- Wound Bed Score ≥4 and <13
Key exclusion criteria (16 listed)
- Absence of factors associated with increased risk of wound infection
- Infected wounds - where infection is defined by:
- A combination of three or more signs or symptoms of local infection: periwound skin erythema, local heat, persistent pain, oedema of wound.s edge, malodour, pus and heavy exudation (Cutting KF, 1994; Trial C, 2010);
- Cellulitis or pus or abscess, Delayed healing, erythema, hardening of edge, serous-purulent drainage, malodour
- Non-vital tissue greater than 25% of the total wound area
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 |
|---|---|---|
| ConnettivinaBio Plus creamAlso: Bionect Plus, Hyalo4 ControlThe Un-blinded Investigator will perform the first application of medication. He will also instruct the patient or his/her caregiver to the self-application of the treatment which will be covered by a secondary dressing according to the site's standard care. | Device | Group 1 ConnettivinaBio Plus cream |
| ConnettivinaBio creamAlso: Bionect, Hyalo4 skinThe Un-blinded Investigator will perform the first application of medication. He will also instruct the patient or his/her caregiver to the self-application of the treatment which will be covered by a secondary dressing according to the site's standard care. | Device | Group 2 ConnettivinaBio cream |
Primary outcome
improving the wounds bed conditions in wounds at high risk of infection, after 14 days of treatment, compared to ConnettivinaBio cream
Time frame: at day 14
The amelioration of wound's bed conditions will be evaluated by measuring the proportion of patients having an increase of at least one subclass of the Wound Bed Score (WBS) (0-16 score; 0 worse score-16 best score possible) (Falanga V, 2006) from baseline to 14 days of treatment with ConnettivinaBio Plus cream compared to ConnettivinaBio cream.
9 secondary outcomes
improving the wound bed condition
Time frame: At days 7, 21 and 28
improving the wound bed condition
Time frame: At days 7, 14, 21 and 28
control of bacterial load of wounds
Time frame: At days 7, 14, 21 and 28
control on signs of wound infection
Time frame: At days 7, 14, 21 and 28
improving the reepithelization rate
Time frame: At days 7, 21 and 28
improving patient's quality of life
Time frame: At days 7, 14, 21 and 28
clinician's global assessment of the lesion
Time frame: At days 7, 14, 21 and 28
easiness of the treatment application
Time frame: at day 28
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: throughout study completion, an average of 1 year
Results and safety
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ConnettivinaBio Plus cream and ConnettivinaBio cream in people with Wounds, 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 16 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Giordan (+39 049 8232111, ngiordan@fidiapharma.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improving the wounds bed conditions in wounds at high risk of infection, after 14 days of treatment, compared to ConnettivinaBio cream (time frame: at day 14). 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.