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Recruiting NCT07312513

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

No phase Interventional Diabetic Ulcers Arterial Ulcers Venous Ulcers Pressure Ulcers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: two sided debridement pad, one sided debridment pad.
Who it may be relevant to
Registry conditions: Diabetic Ulcers, Arterial Ulcers, Venous Ulcers, Pressure Ulcers. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • Device two sided debridement pad
    two sided debridement pad
  • Device one sided debridment pad
    one sided debridment pad

Primary outcome measures

  • Relative reduction of fibrinous and necrotic tissue/slough/debris measured by W.H.A.T. [Time frame: 1 day]
Secondary outcome measures (8)
  • Relative reduction of fibrinous and necrotic tissue/slough/debris measured by he investigator [Time frame: 1 day]
  • Rate of device-related adverse events (device safety) [Time frame: 1 day]
  • Change of wound bed condition, defined by the combination of the following parameters: [Time frame: 1 day]
  • Wound related pain [Time frame: 1 day]
  • Time needed for debridement [Time frame: 1 day]
  • Amount of products [Time frame: 1 day]
  • Patient satisfaction [Time frame: 1 day]
  • User satisfaction [Time frame: 1 day]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Poland · 5 centers
  • MelissaMed Poradnia — Lodz
  • MIKOMED Sp. z.o.o. — Lodz
  • NZOZ Neuromed M. i M. Nastaj — Lublin
  • Specjalistyczny Osrodek Leczniczo Badawczy — Ostróda
  • Lecran - Centrum Opieki Nad Ranami-Kunickiego — Wroclaw

Identifiers

NCT: NCT07312513 · 2024-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗