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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
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
Conditions
Interventions
two sided debridement pad
two sided debridement pad
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