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

Recruiting N/A Interventional Study
Diabetic Ulcers Arterial Ulcers Venous Ulcers Pressure Ulcers Postoperative Wounds Healing by Secondary Intention Burns and Scalds Epidermolysis Bullosa (EB) Traumatic Wounds Surgical Wounds
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
104 (estimated)
Sponsor
Lohmann & Rauscher · Industry
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Patient is legally capable * Patient has signed written informed consent * Presence of one of the following wounds * Venous lower leg ulcer * Arterial ulcer * Diabetic ulcer * Pressure ulcer * Post-operative wound healing by secondary intention * …
Contacts

Claudia Feldkamp

+49 2631 99 7910

claudia.feldkamp@de.lrmed.com

CONTACT