Back to resultsClinical 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
Primary Purpose
Wounds
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ConnettivinaBio Plus cream
ConnettivinaBio cream
Sponsored by
About this trial
This is an interventional treatment trial for Wounds
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- Casa di Cura Villa DonatelloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1 ConnettivinaBio Plus cream
Group 2 ConnettivinaBio cream
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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;
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.
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
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).
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.
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)
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
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.
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
Full Information
NCT ID
NCT04936204
First Posted
October 7, 2020
Last Updated
October 16, 2023
Sponsor
Fidia Farmaceutici s.p.a.
1. Study Identification
Unique Protocol Identification Number
NCT04936204
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fidia Farmaceutici s.p.a.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, randomized, controlled, single-blind clinical investigation
Masking
Outcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1 ConnettivinaBio Plus cream
Arm Type
Experimental
Arm Description
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
Arm Title
Group 2 ConnettivinaBio cream
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
ConnettivinaBio Plus cream
Other Intervention Name(s)
Bionect Plus, Hyalo4 Control
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
ConnettivinaBio cream
Other Intervention Name(s)
Bionect, Hyalo4 skin
Intervention Description
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.
Primary Outcome Measure Information:
Title
improving the wounds bed conditions in wounds at high risk of infection, after 14 days of treatment, compared to ConnettivinaBio cream
Description
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.
Time Frame
at day 14
Secondary Outcome Measure Information:
Title
improving the wound bed condition
Description
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;
Time Frame
At days 7, 21 and 28
Title
improving the wound bed condition
Description
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.
Time Frame
At days 7, 14, 21 and 28
Title
control of bacterial load of wounds
Description
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
Time Frame
At days 7, 14, 21 and 28
Title
control on signs of wound infection
Description
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).
Time Frame
At days 7, 14, 21 and 28
Title
improving the reepithelization rate
Description
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.
Time Frame
At days 7, 21 and 28
Title
improving patient's quality of life
Description
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)
Time Frame
At days 7, 14, 21 and 28
Title
clinician's global assessment of the lesion
Description
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
Time Frame
At days 7, 14, 21 and 28
Title
easiness of the treatment application
Description
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.
Time Frame
at day 28
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
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
Time Frame
throughout study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola Giordan
Phone
+39 049 8232111
Email
ngiordan@fidiapharma.it
Facility Information:
Facility Name
Casa di Cura Villa Donatello
City
Firenze
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Gazzabin, MD
Email
gazzabinluca@gmail.com
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs