Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
NCT ID: NCT07312513
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
104 participants
INTERVENTIONAL
2025-05-09
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Debrisoft Duo
Patients will be treated with the investigational device which is a two sided pad for the debridement of a wide range of wounds. The soft, wide side of the device is identical to the comparator device. The textured, beige side is unique to the investigational device and makes it easy to loosen strongly adherent, fibrinous wound debris.
two sided debridement pad
two sided debridement pad
Debrisoft Pad
Patients will be treated with the comparator device which is a one sided pad for the debridement of a wide range of wounds. The device has the same soft, wide side as the investigational product but does not have the aditional textured, beige side.
one sided debridment pad
one sided debridment pad
Interventions
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two sided debridement pad
two sided debridement pad
one sided debridment pad
one sided debridment pad
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Lohmann & Rauscher
INDUSTRY
AXCELLANT
UNKNOWN
Responsible Party
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Locations
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MelissaMed Poradnia
Lodz, , Poland
MIKOMED Sp. z.o.o.
Lodz, , Poland
NZOZ Neuromed M. i M. Nastaj
Lublin, , Poland
Specjalistyczny Osrodek Leczniczo Badawczy
Ostróda, , Poland
Lecran - Centrum Opieki Nad Ranami-Kunickiego
Wroclaw, , Poland
Countries
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Central Contacts
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Other Identifiers
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2024-03
Identifier Type: -
Identifier Source: org_study_id