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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgical Wounds; Pressure Ulcers; Venous Ulcers; Arterial Ulcers; Diabetic Ulcers; Epidermolysis Bullosa (EB); Traumatic Wounds; Burns and Scalds; Postoperative Wounds Healing by Secondary Intention
• Intervention / Treatment: Device: two sided debridement pad; Device: one sided debridment pad

Detailed Description

This clinical investigation will be conducted as multicenter, randomized in parallel groups, non-inferiority controlled trial. After randomization patients will receive wound debrided with the investigational device or the comparator device during one study visit. During the study visit patients will have clinical examination and wound photos will be taken.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudia Feldkamp; Phone Number: +49 2631 99 7910; Email: claudia.feldkamp@de.lrmed.com

Study Locations

• Poland
  • Lodz, Poland, 94-102
    • Recruiting
    • MelissaMed Poradnia
  • Lodz, Poland, 94-238
    • Recruiting
    • MIKOMED Sp. z.o.o.
  • Lublin, Poland, 20-640
    • Recruiting
    • NZOZ Neuromed M. i M. Nastaj
  • Ostróda, Poland, 14-100
    • Recruiting
    • Specjalistyczny Osrodek Leczniczo Badawczy
  • Wroclaw, Poland, 54-616
    • Recruiting
    • Lecran - Centrum Opieki Nad Ranami-Kunickiego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 debridement, as determined by the investigator, are permitted and may be also pre-moistened before the procedure if deemed necessary

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: two sided debridement pad; two sided debridement pad
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.	Device: one sided debridment pad; one sided debridment pad

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative reduction of fibrinous and necrotic tissue/slough/debris measured by W.H.A.T.	Wound photos will be taken. On these photos, the amount of fibrinous and necrotic tissue/slough/debris in the wound bed before and after debridement will be measured by W.H.A.T. (Wound Healing Analyzing Tool).	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative reduction of fibrinous and necrotic tissue/slough/debris measured by he investigator	The amount of fibrinous and necrotic tissue/slough/debris in the wound bed before and after debridement will be measured by the investigator.	1 day
Rate of device-related adverse events (device safety)	Frequency and character of device deficiencies (DDs), adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), serious adverse device effects (SADEs) and incidents.	1 day
Change of wound bed condition, defined by the combination of the following parameters:	Change in grade of exudate (from very high to none); Change in type of exudate (from haemorrhagic to serous); Change of the wound surrounding skin (presence or abscence of normal, erosive, dry/scaling, dry cracking, oeadematous, red or discoloured skin and cream residues); Change of the wound bed and wound edges (presence or abscence of debris, discoloration, maceration, hyperkeratosis, smooth skin, thickened/rolled edges, undermining, vital tissue, biofilm); Removal of biofilm (estimated by the user)	1 day
Wound related pain	Wound related pain will be measured directly before, during and 10 +/-2 minutes using NRS-11 scale	1 day
Time needed for debridement	Time needed for the debridement procedure will be assessed using a stopper	1 day
Amount of products	Amount of products that were used during one debridement session will be assessed.	1 day
Patient satisfaction	Patient satisfaction with the treatment procedure on a scale from 1-5	1 day
User satisfaction	User satisfaction assessed via a questionnaire	1 day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in wound size	Wound size will be compared before and after the debridement procedure	1 day
Results of biopsy or smear	If performed during clinical routine, results of biopsy or smear will be assessed	1 day
Removal of biofilm	Change in the presence of biofilm before and after debridement will be investigated using MolecuLightDX. This will only be done at one of the five participating sites.	1 day

Collaborators and Investigators

• Sponsor: Lohmann & Rauscher
• Collaborators: AXCELLANT

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Debridement; mechanical debridement
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Genetic Diseases, Inborn; Skin Diseases; Skin Ulcer; Varicose Veins; Congenital Abnormalities; Leg Ulcer; Skin Diseases, Genetic; Skin Abnormalities; Skin Diseases, Vesiculobullous; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Surgical Wound; Varicose Ulcer; Burns; Epidermolysis Bullosa; Pressure Ulcer
• Other Study ID Numbers: 2024-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No