Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
Recruiting
N/AInterventional Study
Diabetic UlcersArterial UlcersVenous UlcersPressure UlcersPostoperative Wounds Healing by Secondary IntentionBurns and ScaldsEpidermolysis Bullosa (EB)Traumatic WoundsSurgical 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
Who this trial is looking for
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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
* …
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
* Traumatic wound
* Surgical wound
* Burn or scald (grade III: after surgical debridement)
* Epidermolysis Bullosa
* Wound area \>4cm2
* The entire wound area can be displayed on one photo from a distance of 25-30 cm
* Covered with at least 30% debris, necrosis, slough, fibrotic tissue
Exclusion Criteria:
* 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
* Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and/ or interpretation of the study results
* severe pain or hyperesthesia in the wound area
* history of drug or alcohol abuse
* chronic analgesic use (especially opioids) that could influence baseline pain perception
* cognitive impairment, which may affect the ability to accurately self-report pain
* Use of anaesthesia before the debridment procedure
* presence of hard necrotic tissue or other tissue which should not be debrided in general. Other types of hard necrotic tissue requiring debridement, as determined by the investigator, are permitted and may be also pre-moistened before the procedure if deemed necessary
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