Performance and Safety of a New Medical Device (Polybactum) for Reducing the Recurrence Rate of Bacterial Vaginosis: Protocol for a Multicenter, Open-Label, Noncontrolled International Clinical Trial (POLARIS Study)

Performance and Safety of a New Medical Device (Polybactum) for Reducing the Recurrence Rate of Bacterial Vaginosis: Protocol for a Multicenter, Open-Label, Noncontrolled International Clinical Trial (POLARIS Study)

BackgroundThe medical literature has reported that recurrent bacterial vaginosis (RBV) has a relapse rate of 35% within 3 months and 60% within 12 months after antibiotic administration. Products that are able to provide a barrier effect against the biofilm produced by Gardne...

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Main Authors: Filippo Murina, Paolo Inghirami, Marius Biriș, Daniela Sîrbu, Dionisio Franco Barattini, Federica Sbrocca, Luca Ivan Ardolino, Mario Mangrella, Elena Casolati, Serban Roșu, Ciprian Doru Crișan
Format: Article
Language:English
Published: JMIR Publications 2023-07-01
Series:JMIR Research Protocols
Online Access:https://www.researchprotocols.org/2023/1/e42787

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