Management of Acute and Chronic Wounds With Hyaluronic Acid

• Sponsor: Fidia Farmaceutici s.p.a. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06108999
• Collaborator: (none)
• Enrollment: 170
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 26.1
• Patients Per Site: 56.7
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the performance and safety of the use of Connettivina Bio in terms of wound management. 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, in different Italian healthcare facilities.

Condition or Disease	Intervention/Treatment	Phase
Wound Heal; Wound; Foot	Device: Connettivina BIO cream and gauze	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 170 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 29, 2022
• Anticipated Primary Completion Date: Feb 28, 2024
• Anticipated Study Completion Date: Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Connettivia BIO Cream All the subjects will be treated with Connettivina BIO line (Cream or Gauze)	Device: Connettivina BIO cream and gauze; Is to evaluate the performance and safety of Connettivina Bio cream and gauze-pad in the management of acute or chronic wounds of different etiology, according to the indication for use. Only one wound per patient will be considered for the treatment according to the study protocol. The schedule treatment will consist of daily medication changes, according to the instruction for use and the clinical practice, for a maximum of 7 Visits.
Experimental: Connettivina BIO Gauze All the subjects will be treated with Connettivina BIO line (Cream or Gauze)	Device: Connettivina BIO cream and gauze; Is to evaluate the performance and safety of Connettivina Bio cream and gauze-pad in the management of acute or chronic wounds of different etiology, according to the indication for use. Only one wound per patient will be considered for the treatment according to the study protocol. The schedule treatment will consist of daily medication changes, according to the instruction for use and the clinical practice, for a maximum of 7 Visits.

Outcome Measures

Primary Outcome Measures

1. Evaluate the performance of Connettivina Bio line in the amelioration of wound bed appearance [14 days]

   The performance of Connettivina Bio line in the amelioration of wound bed appearance will be evaluated from baseline to 14 days of treatment, as the percentage of patients showing a change in at least one of the following 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).

Secondary Outcome Measures

1. Number of Participants With Treatment-Related Adverse Events [8 weeks]

   The safety and tolerability of Connettivina Bio 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Grandi Ustionati OSPEDALE BUFALINI DI CESENA - (FC)	Cesena	Forlì-Cesena	Italy	47521
2	AOU Ospedali Riuniti SOD-Clinica di Chirurgia Plastica e Ricostruttiva	Ancona		Italy	60127
3	Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - SC (UCO)	Trieste		Italy	34121

Sponsors and Collaborators

• Fidia Farmaceutici s.p.a.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fidia Farmaceutici s.p.a.
• ClinicalTrials.gov Identifier: NCT06108999
• Other Study ID Numbers: AQ04-20-01
• First Posted: Oct 31, 2023
• Last Update Posted: Oct 31, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

No Results Posted as of Oct 31, 2023