Management of Acute and Chronic Wounds With Hyaluronic Acid

NCT06108999 | Recruiting

• 1 other identifier: AQ04-20-01
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Wound Heal; Wound; Foot

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events

  8 weeks

Study Arms (2)

Connettivia BIO Cream

EXPERIMENTAL

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

Device: Connettivina BIO cream and gauze

Connettivina BIO Gauze

EXPERIMENTAL

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

Device: Connettivina BIO cream and gauze

Interventions

Connettivina BIO cream and gauze DEVICE

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.

Connettivia BIO Cream; Connettivina BIO Gauze

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients \< 18 years.
• Patients with acute or chronic infected lesions.
• Hospitalized patients.
• 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.
• 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.

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (3)

Centro Grandi Ustionati OSPEDALE BUFALINI DI CESENA - (FC)

Cesena, Forlì-Cesena, 47521, Italy

NOT YET RECRUITING

AOU Ospedali Riuniti SOD-Clinica di Chirurgia Plastica e Ricostruttiva

Ancona, 60127, Italy

RECRUITING

Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - SC (UCO)

Trieste, 34121, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Foot Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Central Study Contacts

Niocola Giordan

CONTACT

+39 349 823 2111; ngiordan@fidiapharma.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 31, 2023
• Study Start: July 29, 2022
• Primary Completion: February 28, 2024
• Study Completion: September 30, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

IT (3)