Management of Acute and Chronic Wounds With Hyaluronic Acid

Wound Heal Clinical Trial

Official title:

Prospective, Multicentric, Post-market Clinical Investigation to Evaluate the Performance and Safety of Connettivina Bio Line in Management of Acute and Chronic Wounds

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06108999
• Other study ID #: AQ04-20-01
• Status: Recruiting
• Phase: N/A
• Start date: July 29, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: Fidia Farmaceutici s.p.a.
• Contact: Niocola Giordan
• Phone: +39 349 823 2111
• Email: ngiordan[@]fidiapharma.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: September 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound Heal
• Wound; Foot
• Wounds and Injuries

Intervention

Device:
• Connettivina BIO cream and gauze
Connettivina Bio cream and gauze-pad efficacy and tolerability will be evaluated in the management of acute or chronic wounds of different etiology, according to instruction for use. Only one wound per patient will be considered for the treatment according to the study protocol. The schedule treatment will consist on a daily medication changes, according to the instruction for use and the clinical practice, for a maximum of 7 Visits.

Locations

Country	Name	City	State
Italy	AOU Ospedali Riuniti SOD-Clinica di Chirurgia Plastica e Ricostruttiva	Ancona
Italy	Centro Grandi Ustionati OSPEDALE BUFALINI DI CESENA - (FC)	Cesena	Forlì-Cesena
Italy	Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - SC (UCO)	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
Fidia Farmaceutici s.p.a.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the performance of Connettivina Bio line in the amelioration of wound bed appearance	The performance of Connettivina Bio line, in the amelioration of wound bed appearance, will be evaluated from baseline up to 14 days of treatment. The percentage of patients showing a change in at least of one of the following evaluated parameters: amelioration of wound tissue type (necrotic, slough, granulation tissue, epithelial tissue, closed), decrease of exudate amount (dry, moist, slightly exuding, heavily exuding, wet) and amelioration of exudate type (bloody, bloody/purulent, clear, murky, purulent, serous).	14 days
Secondary	Number of Participants With Treatment-Related Adverse Events	The safety and tolerability of Connettivina Bio will be assessed throughout all the visits by investigating local and expected adverse events, as a consequence of the product application. Additionally, any other adverse event occurred during the study will be considered and evaluated	8 weeks