Management of Acute and Chronic Wounds With Hyaluronic Acid

May 8, 2024 updated by: Fidia Farmaceutici s.p.a.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ancona, Italy, 60127
        • Recruiting
        • AOU Ospedali Riuniti SOD-Clinica di Chirurgia Plastica e Ricostruttiva
        • Contact:
          • Alessandro Scalise
      • Trieste, Italy, 34121
        • Not yet recruiting
        • Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - SC (UCO)
        • Contact:
          • Luca Spazzapan
    • Forlì-Cesena
      • Cesena, Forlì-Cesena, Italy, 47521
        • Not yet recruiting
        • Centro Grandi Ustionati OSPEDALE BUFALINI DI CESENA - (FC)
        • Contact:
          • Rossella Sgarzani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Connettivia BIO Cream
All subjects will be treated with Connettivina BIO line (Cream or Gauze)
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.
Experimental: Connettivina BIO Gauze
All subjects will be treated with Connettivina BIO line (Cream or Gauze)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the performance of Connettivina Bio line in the amelioration of wound bed appearance
Time Frame: 14 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Related Adverse Events
Time Frame: 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fidia Farmaceutici s.p.a.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2022

Primary Completion (Actual)

February 28, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

October 16, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AQ04-20-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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