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RECRUITING
NCT06108999
NA

Management of Acute and Chronic Wounds With Hyaluronic Acid

Sponsor: Fidia Farmaceutici s.p.a.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2022-07-29

Completion Date

2024-09-30

Last Updated

2024-05-09

Healthy Volunteers

No

Interventions

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 (3)

Centro Grandi Ustionati OSPEDALE BUFALINI DI CESENA - (FC)

Cesena, Forlì-Cesena, Italy

AOU Ospedali Riuniti SOD-Clinica di Chirurgia Plastica e Ricostruttiva

Ancona, Italy

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

Trieste, Italy