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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Relative reduction of fibrinous and necrotic tissue/slough/debris measured by W.H.A.T.