Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07312513

Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds

Led by Lohmann & Rauscher · Updated on 2025-12-31

104

Participants Needed

5

Research Sites

38 weeks

Total Duration

On this page

Sponsors

L

Lohmann & Rauscher

Lead Sponsor

A

AXCELLANT

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 5 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
  • Wound covered with at least 30% debris, necrosis, slough, fibrotic tissue
Not Eligible

You will not qualify if you...

  • Known allergy and/or hypersensitivity to Debrisoft� Duo or any of the product components
  • Pregnancy or breast feeding
  • Patient is illiterate
  • Participation in an interventional clinical trial within the last 14 days and during participation in this study
  • Any other medical condition which may impact the success or interpretation of the study treatment
  • 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 affecting ability to accurately report pain
  • Use of anaesthesia before the debridement procedure
  • Presence of hard necrotic tissue or other tissue which should not be debrided in general (exceptions as determined by investigator)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

MelissaMed Poradnia

Lodz, Poland, 94-102

Actively Recruiting

2

MIKOMED Sp. z.o.o.

Lodz, Poland, 94-238

Actively Recruiting

3

NZOZ Neuromed M. i M. Nastaj

Lublin, Poland, 20-640

Actively Recruiting

4

Specjalistyczny Osrodek Leczniczo Badawczy

Ostróda, Poland, 14-100

Actively Recruiting

5

Lecran - Centrum Opieki Nad Ranami-Kunickiego

Wroclaw, Poland, 54-616

Actively Recruiting

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Research Team

C

Claudia Feldkamp

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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