Clinical trial NCT04652752: Clinical Investigation to Evaluate the Safety and Efficacy of Dressing CONNETTIVINA HI TECH in the Management of Superficial Cutaneous Lesions
Official title: A Prospective, Open, Clinical Trial to Evaluate the Safety and Efficacy of Dressing CONNETTIVINA HI TECH in the Management of Superficial Cutaneous Lesions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Superficial Cutaneous Lesions
Lead sponsor: Fidia Farmaceutici s.p.a.
Sponsor class: INDUSTRY
First posted: 2020-12-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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:

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

Primary outcomes:
measure: Change in dimentions of lesion in patients compared to baseline
timeFrame: at 14 days
Secondary outcomes:
measure: Healing rate as a difference in the mean percentage reduction of lesion area from baseline in patients treated with CONNETTIVINA HI TECH
timeFrame: at 2,8, 14, 20 and 26 days
measure: Patient's satisfaction with CONNETTIVINA HI TECH
timeFrame: at 2,8, 14, 20 and 26 days
measure: Clinician's global assessment of the lesion (CGA)
timeFrame: at 2,8, 14, 20 and 26 days
measure: Evaluation of dressing Adhesion
timeFrame: at day 28
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: at 2,8, 14, 20 and 26 days
Other outcomes:
Locations:
city: Ravenna
country: Italy
facility: Centro Iperbarico di Ravenna
Study officials:
References: