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

NCT04936204 | Unknown

• 1 other identifier: HQQ2-19-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• improving the wound bed condition

  At days 7, 21 and 28

• improving the wound bed condition

  At days 7, 14, 21 and 28

• control of bacterial load of wounds

  At days 7, 14, 21 and 28

• control on signs of wound infection

  At days 7, 14, 21 and 28

• improving the reepithelization rate

  At days 7, 21 and 28

Study Arms (2)

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

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

Device: ConnettivinaBio cream

Interventions

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.

Also known as: Bionect Plus, Hyalo4 Control

Group 1 ConnettivinaBio Plus cream

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.

Also known as: Bionect, Hyalo4 skin

Group 2 ConnettivinaBio cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (1)

Casa di Cura Villa Donatello

Florence, Italy

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

Nicola Giordan

CONTACT

+39 049 8232111; ngiordan@fidiapharma.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A prospective, randomized, controlled, single-blind clinical investigation

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: June 23, 2021
• Study Start: June 10, 2021
• Primary Completion: April 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

IT (1)