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RECRUITING
NCT07312513
NA

Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds

Sponsor: Lohmann & Rauscher

View on ClinicalTrials.gov

Summary

The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2025-05-09

Completion Date

2026-02

Last Updated

2025-12-31

Healthy Volunteers

No

Interventions

DEVICE

two sided debridement pad

two sided debridement pad

DEVICE

one sided debridment pad

one sided debridment pad

Locations (5)

MelissaMed Poradnia

Lodz, Poland

MIKOMED Sp. z.o.o.

Lodz, Poland

NZOZ Neuromed M. i M. Nastaj

Lublin, Poland

Specjalistyczny Osrodek Leczniczo Badawczy

Ostróda, Poland

Lecran - Centrum Opieki Nad Ranami-Kunickiego

Wroclaw, Poland