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

NCT ID: NCT04936204

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-10
• Study Completion Date: 2024-12-31

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.

Conditions

Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 1 ConnettivinaBio Plus cream

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

Group Type: EXPERIMENTAL

ConnettivinaBio Plus cream

Intervention Type: 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.

Group 2 ConnettivinaBio cream

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

Group Type: ACTIVE_COMPARATOR

ConnettivinaBio cream

Intervention Type: 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.

Interventions

ConnettivinaBio Plus cream

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

ConnettivinaBio cream

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

Other Intervention Names

Bionect Plus; Hyalo4 Control; Bionect; Hyalo4 skin

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fidia Farmaceutici s.p.a.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Casa di Cura Villa Donatello

Florence, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Nicola Giordan

Role: CONTACT

ngiordan@fidiapharma.it

+39 049 8232111

Facility Contacts

Luca Gazzabin, MD

Role: primary

gazzabinluca@gmail.com

Other Identifiers

HQQ2-19-01

Identifier Type: -

Identifier Source: org_study_id