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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ConnettivinaBio Plus cream | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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; | At days 7, 21 and 28 |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicola Giordan | Contact | +39 049 8232111 | ngiordan@fidiapharma.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casa di Cura Villa Donatello | Recruiting | Florence | Italy |
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A prospective, randomized, controlled, single-blind clinical investigation
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At Screening/Baseline visit patients who signed the informed consent and are eligible for the study will be screened by the Investigator who will gather demographic and medical history data and perform the randomization procedure. After the allocation of the patient to Group 1 or 2, the Un-blinded Investigator will perform the treatment, according to the group allocation and instruct the patients on dressing daily renewal. The Investigator, who won't take part in the administration of study treatments and won't be aware on the patient.s group assignment, will perform all the evaluations for primary and secondary endpoint, during the visits (Blinded Evaluator).
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| ConnettivinaBio cream | Device | 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. |
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| 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. | 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 | 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). | 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. | 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) | 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 | 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. | 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 | throughout study completion, an average of 1 year |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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