Superficial Cutaneous Lesions Clinical Trial
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
| Verified date | October 2023 |
| Source | Fidia Farmaceutici s.p.a. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 20 |
| Est. completion date | December 30, 2022 |
| Est. primary completion date | March 31, 2022 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 85 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Centro Iperbarico di Ravenna | Ravenna |
| Lead Sponsor | Collaborator |
|---|---|
| Fidia Farmaceutici s.p.a. |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |