Clinical Investigation to Evaluate the Safety and Efficacy of Dressing CONNETTIVINA HI TECH in the Management of Superficial Cutaneous Lesions

A Prospective, Open, Clinical Trial to Evaluate the Safety and Efficacy of Dressing CONNETTIVINA HI TECH in the Management of Superficial Cutaneous Lesions

This is an open, single arm, prospective clinical investigation to evaluate the performance of CONNETTIVINA HI TECH, in terms of safety and efficacy in the management of superficial cutaneous lesions. The study will be conducted in one center, in Italy and will enroll 50 subjects . Subjects will be followed until confirmation of complete wound closure, and for a maximum of 26 days, with a follow up of 4 days after re-epithelization will be confirmed.

Study Overview

• Status: Terminated
• Conditions: Superficial Cutaneous Lesions
• Intervention / Treatment: Device: CONNETTIVINA HI TECH patch

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ravenna, Italy
    • Centro Iperbarico di Ravenna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Signed written informed consent.
• Male or female ≥ 18 and ≤ 85 years
• Having a superficial cutaneous lesion of different etiology, with the following characteristics:

Wound bed appearance of grade ≥15 of WBS (Wound Bed Score: Falanga 2006) Absence of clinical signs or symptoms of local infection (as defined by CDC/NHSN) Size: between 5 and 32 cm2 that can be covered by a dressing of 4x8cm

• In case of multiple lesions per patient, only one lesion will be considered for the treatment (the better choice for self-evaluation of lesion by patient)
• Patient able to maintain a Patient's Diary during the study
• 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 and able to comply with the study requirements
• Ensured compliance of subjects for the study period

Exclusion Criteria:

1. Patients who not sign the informed consent form
2. Patients with non-superficial wounds exposing bones, tendon or muscle bundles.
3. Patients with WBS score under or equal to 14 ("severe exudate amount", or "moderate exudate amount" and "moderate per-wound dermatitis" or "moderate callous peri-wound")
4. Presence of signs of infection as defined by CDC/NHMS
5. History of connective tissue disease, e.g., systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease
6. Uncontrolled congestive heart failure
7. Active malignant disease
8. Active sickle cell disease
9. Patients who are immunocompromised for reasons such as therapy with corticosteroids, chemotherapy, antiangiogenic or immunosuppressive agents, or due to immunodeficiency syndromes
10. Known allergy to any of the devices' constituents
11. Women who are pregnant, breastfeeding or who have not reached menopause and are not abstinent or practicing an acceptable means of birth control as determined by the Investigator for the duration of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CONNETTIVINA HI TECH patch; CONNETTIVINA HI TECH patch will be applied to eligible patients. CONNETTIVINA HI TECH will be renewed every two day, according with general principles of wound management	Device: CONNETTIVINA HI TECH patch; It is a medical device for topical application in the form of a patch with adhesive transparent polyurethane edge and a central pad impregnated with a solution of hyaluronic acid sodium salt, able to create a hydrating environment, such as to favor the natural healing process of tissue repair in case of bruises, abrasions, small cuts, superficial wounds, burns

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dimentions of lesion in patients compared to baseline	Change from of superficial cutaneous lesions by measuring the area of the superficial lesion after 14 days of treatment	at 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of dressing Adhesion	Evaluation of dressing adhesion evaluated at each visit by considering the effective frequency of dressing change and comparing it with the frequency indicated by the clinical investigation plan	at day 28
Healing rate as a difference in the mean percentage reduction of lesion area from baseline in patients treated with CONNETTIVINA HI TECH	The healing rate will be evaluated at all time points as a difference in the mean percentage reduction of lesion area from baseline measured by a wound imaging device	at 2,8, 14, 20 and 26 days
Patient's satisfaction with CONNETTIVINA HI TECH	Patient's satisfaction with CONNETTIVINA HI TECH will be evaluated at each post baseline visit: patients will assess their degrees of satisfaction with the use of the dressing by the means of a 5 grade scale	at 2,8, 14, 20 and 26 days
Clinician's global assessment of the lesion (CGA)	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	at 2,8, 14, 20 and 26 days
Number of Participants With Treatment-Related Adverse Events	The safety and tolerability of treatments 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.	at 2,8, 14, 20 and 26 days

Collaborators and Investigators

• Sponsor: Fidia Farmaceutici s.p.a.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2019
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: AQ04-19-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No