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

NCT04652752 | Terminated DMC

• 1 other identifier: AQ04-19-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Superficial Cutaneous Lesions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Healing rate as a difference in the mean percentage reduction of lesion area from baseline in patients treated with CONNETTIVINA HI TECH

  at 2,8, 14, 20 and 26 days

• Patient's satisfaction with CONNETTIVINA HI TECH

  at 2,8, 14, 20 and 26 days

• Clinician's global assessment of the lesion (CGA)

  at 2,8, 14, 20 and 26 days

• Evaluation of dressing Adhesion

  at day 28

• Number of Participants With Treatment-Related Adverse Events

  at 2,8, 14, 20 and 26 days

Study Arms (1)

CONNETTIVINA HI TECH patch

EXPERIMENTAL

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

Interventions

CONNETTIVINA HI TECH patch DEVICE

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

CONNETTIVINA HI TECH patch

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who not sign the informed consent form
• Patients with non-superficial wounds exposing bones, tendon or muscle bundles.
• 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")
• Presence of signs of infection as defined by CDC/NHMS
• History of connective tissue disease, e.g., systemic lupus erythematosus, systemic sclerosis, Sjögren's syndrome or mixed connective tissue disease
• Uncontrolled congestive heart failure
• Active malignant disease
• Active sickle cell disease
• Patients who are immunocompromised for reasons such as therapy with corticosteroids, chemotherapy, antiangiogenic or immunosuppressive agents, or due to immunodeficiency syndromes
• Known allergy to any of the devices' constituents
• 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

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (1)

Centro Iperbarico di Ravenna

Ravenna, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: December 3, 2020
• Study Start: October 12, 2019
• Primary Completion: March 31, 2022
• Study Completion: December 30, 2022
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

IT (1)