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

ConditionsDiabetic Ulcers Arterial Ulcers Venous Ulcers Pressure Ulcers Postoperative Wounds Healing by Secondary Intention Burns and Scalds Epidermolysis Bullosa (EB)Traumatic Wounds Surgical Wounds

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorLohmann & Rauscher

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Patient is legally capable

Patient has signed written informed consent

Presence of one of the following wounds

Disqualifiers

Known allergy and/or hypersensitivity to Debrisoft® Duo or any of the product components

Pregnancy or breast feeding

Patient is illiterate

Participation in a interventional clinical trial within the last 14 days and during participation in this study

Trial design

Treatments tested in this trial

two sided debridement pad
one sided debridment pad

Treatment groups

104 Participants

are divided into 2 treatment groups

Locations

MelissaMed Poradnia94-102, Lodz Poland

MIKOMED Sp. z.o.o.94-238, Lodz Poland

NZOZ Neuromed M. i M. Nastaj20-640, Lublin Poland

Specjalistyczny Osrodek Leczniczo Badawczy14-100, Ostróda Poland

Sponsors and collaborators

Lohmann & Rauscher

Lead sponsor

AXCELLANT

Collaborator

Source ClinicalTrials.gov