Management of Acute and Chronic Wounds With Hyaluronic Acid

Fidia Pharma

Status: Enrolling

Conditions: Wound; Foot; Wound Heal

Treatments: Device: Connettivina BIO cream and gauze

Study type: Interventional

Funder types: Industry

Identifiers

NCT06108999

AQ04-20-01

Details and patient eligibility

About

The purpose of this study is to evaluate the performance and safety of Connettivina Bio, when used in the management of wounds. Moreover, the study will evaluate the correlation of the 'dressing system' (formed by the Connettivina Bio primary dressing plus a secondary one) used in different care settings. The study will include Italian healthcare facilities.

Full description

The primary objective of the prospective, multicentric, post-market clinical investigation is to evaluate the performance of Connettivina Bio (cream, gauze-pads) in the amelioration of wound bed appearance after 14 days of treatment. This objective will be assessed by measuring the percentage of patients showing, from baseline to 14 days of treatment, positive change in at least one of the following parameters: amelioration of wound tissue type (4=necrotic, 3=slough, 2=granulation tissue, 1=epithelial tissue, 0=closed), decrease of exudate amount (1=dry, 2=moist,3= slightly exuding, 4=heavily exuding, 5=wet) and amelioration of exudate type (1=bloody, 2=bloody/purulent, 3=clear, 4=murky,5= purulent, 6=serous). Furthermore, the secondary objectives of this clinical investigation include to define the Investigator's choice in clinical practice of Connettivina Bio (cream, gauze-pad) related to the clinical wound characteristics, the type of secondary dressing applied on the wound and the wound etiology, for this reason a descriptive analysis will be performed at baseline. Additionally, for the secondary objectives, the performance of Connettivina Bio (cream, gauze-pads) will be evaluated from baseline to 7, 21, 28, 42 and 56 days as amelioration of wound bed appearance in terms of type of wound bed tissue and exudate quantity and quality. To evaluate the improvement of quality of life of patients treated, the latter will be evaluated as a change from baseline to 56 days after the start of treatment, through administration of EuroQoL-5D (EQ-5D). Moreover, to evaluate the easiness of Connettivina Bio (cream, gauze-pads) application, the latter will be appraised by the clinician and by the patient after 56 days from the start of treatment as excellent, good, acceptable, bad or unacceptable. Finally, the safety and tolerability of Connettivina Bio (cream, gauze-pads) will be assessed throughout all the visits by investigating local and expected adverse events, as consequence of the product application and any other adverse event occurred during the study.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed written informed consent.
2. Male or female ≥18 years.
3. Patients selected to be treated with Connettivina Bio.
4. Patients with wound of the following etiology: first and second degree burns; surgical wounds; vascular ulcers; metabolic ulcers; pressure ulcers.
5. Patients followed on an outpatient or home basis.
6. Wound area ≥ 10 cm2 and ≤ 100 cm2

Exclusion criteria

1. Patients < 18 years.

2. Patients with acute or chronic infected lesions.

3. Hospitalized patients.

4. Patients with acute or chronic lesions at high risk of infection, presenting at least one of the following criteria:

   • Stalled wound, without any clinical sign of healing progression
   • Immune system disorders
   • Protein-energy malnutrition
   • Alcohol, smoking and drug abuse
   • Conditions associated with hypoxia and/or poor tissue perfusion
   • Corticosteroid, cytotoxic or immunosuppressive therapy.

5. Subjects unable to understand informed consent or having a high probability of non-compliance with the study procedures and or non-completion of the study according to investigator's judgement.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Connettivia BIO Cream

Experimental group

Description:

All subjects will be treated with Connettivina BIO line (Cream or Gauze)

Treatment:

Device: Connettivina BIO cream and gauze

Connettivina BIO Gauze

Experimental group

Description:

All subjects will be treated with Connettivina BIO line (Cream or Gauze)

Treatment:

Device: Connettivina BIO cream and gauze