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

NCT07312513 | Recruiting

• 1 other identifier: 2024-03
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Diabetic Ulcers; Arterial Ulcers; Venous Ulcers; Pressure Ulcers; Burns and Scalds; Epidermolysis Bullosa (EB); Traumatic Wounds; Surgical Wounds; Postoperative Wounds Healing by Secondary Intention

Keywords

Debridement; mechanical debridement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Relative reduction of fibrinous and necrotic tissue/slough/debris measured by he investigator

  1 day

• Rate of device-related adverse events (device safety)

  1 day

• Change of wound bed condition, defined by the combination of the following parameters:

  1 day

• Wound related pain

  1 day

• Time needed for debridement

  1 day

Other Outcomes (3)

• Change in wound size

  1 day

• Results of biopsy or smear

  1 day

• Removal of biofilm

  1 day

Study Arms (2)

Debrisoft Duo

EXPERIMENTAL

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

Debrisoft Pad

ACTIVE COMPARATOR

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

Interventions

two sided debridement pad DEVICE

two sided debridement pad

Debrisoft Duo

one sided debridment pad DEVICE

one sided debridment pad

Debrisoft Pad

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lohmann & Rauscher: lead
• AXCELLANT: collaborator

Study Sites (5)

MelissaMed Poradnia

Lodz, 94-102, Poland

RECRUITING

MIKOMED Sp. z.o.o.

Lodz, 94-238, Poland

RECRUITING

NZOZ Neuromed M. i M. Nastaj

Lublin, 20-640, Poland

RECRUITING

Specjalistyczny Osrodek Leczniczo Badawczy

Ostróda, 14-100, Poland

RECRUITING

Lecran - Centrum Opieki Nad Ranami-Kunickiego

Wroclaw, 54-616, Poland

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer; Pressure Ulcer; Burns; Epidermolysis Bullosa; Surgical Wound

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Vesiculobullous

Central Study Contacts

Claudia Feldkamp

CONTACT

+49 2631 99 7910; claudia.feldkamp@de.lrmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 31, 2025
• Study Start: May 9, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (5)