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Management of Acute and Chronic Wounds With Hyaluronic Acid
Sponsor: Fidia Farmaceutici s.p.a.
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
Conditions
Interventions
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