Arterial Ulcers, Burns and Scalds, Diabetic Ulcers, Epidermolysis Bullosa (EB), Postoperative Wounds Healing by Secondary Intention, Pressure Ulcers, Surgical Wounds, Traumatic Wounds, Venous Ulcers
Conditions
Keywords
Debridement, mechanical debridement
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.
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
DEVICEtwo sided debridement pad
two sided debridement pad
DEVICEone sided debridment pad
one sided debridment pad
Sponsors
Lohmann & Rauscher
AXCELLANT
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative reduction of fibrinous and necrotic tissue/slough/debris measured by W.H.A.T. | 1 day | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative reduction of fibrinous and necrotic tissue/slough/debris measured by he investigator | 1 day | 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) | 1 day | 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: | 1 day | * 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 | 1 day | Wound related pain will be measured directly before, during and 10 +/-2 minutes using NRS-11 scale |
| Time needed for debridement | 1 day | Time needed for the debridement procedure will be assessed using a stopper |
| Amount of products | 1 day | Amount of products that were used during one debridement session will be assessed. |
| Patient satisfaction | 1 day | Patient satisfaction with the treatment procedure on a scale from 1-5 |
| User satisfaction | 1 day | User satisfaction assessed via a questionnaire |
Countries
Poland
Outcome results
None listed