Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft… (NCT07312513) | Clinical Trial Compass
RecruitingNot Applicable
Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
Poland104 participantsStarted 2025-05-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 debridemen…
What they're measuring
1
Relative reduction of fibrinous and necrotic tissue/slough/debris measured by W.H.A.T.