Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Poland
MelissaMed Poradnia
RECRUITING
Lodz
MIKOMED Sp. z.o.o.
RECRUITING
Lodz
NZOZ Neuromed M. i M. Nastaj
RECRUITING
Lublin
Specjalistyczny Osrodek Leczniczo Badawczy
RECRUITING
Ostróda
Lecran - Centrum Opieki Nad Ranami-Kunickiego
RECRUITING
Wroclaw
Contact Information
Primary
Claudia Feldkamp
claudia.feldkamp@de.lrmed.com
+49 2631 99 7910
Time Frame
Start Date:2025-05-09
Estimated Completion Date:2026-02
Participants
Target number of participants:104
Treatments
Experimental: 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.
Active_comparator: 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.