RecruitingNot ApplicableNCT06108999

Management of Acute and Chronic Wounds With Hyaluronic Acid

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

Sponsor

Fidia Farmaceutici s.p.a.

Enrollment

170 participants

Start Date

Jul 29, 2022

Study Type

INTERVENTIONAL

Conditions

Wound Heal Wound; Foot

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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

Exclusion Criteria11

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.

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Interventions

DEVICEConnettivina 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.