Clinical Investigation to Evaluate the Safety and Efficac... | NCT04652752

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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:

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