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.
Age ≥ 18 years
Patient is legally capable
Patient has signed written informed consent
Presence of one of the following wounds
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
Parallel
two sided debridement pad
Devicetwo sided debridement pad
one sided debridment pad
Deviceone sided debridment pad
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).
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.
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.
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)
Wound related pain
Wound related pain will be measured directly before, during and 10 +/-2 minutes using NRS-11 scale
Change in wound size
Wound size will be compared before and after the debridement procedure
Results of biopsy or smear
If performed during clinical routine, results of biopsy or smear will be assessed
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.
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Lohmann & Rauscher
Lead sponsor
AXCELLANT
Collaborator
