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| Name | Class |
|---|---|
| AXCELLANT | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| two sided debridement pad | Device | two sided debridement pad |
| |
| 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 |
| 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) |
| 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 |
Inclusion Criteria:
Age ≥ 18 years
Patient is legally capable
Patient has signed written informed consent
Presence of one of the following wounds
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudia Feldkamp | Contact | +49 2631 99 7910 | claudia.feldkamp@de.lrmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MelissaMed Poradnia | Recruiting | Lodz | 94-102 | Poland | ||
| MIKOMED Sp. z.o.o. |
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| one sided debridment pad |
| Device |
one sided debridment pad |
|
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: |
| 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 |
| 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 |
| Recruiting |
| Lodz |
| 94-238 |
| Poland |
| NZOZ Neuromed M. i M. Nastaj | Recruiting | Lublin | 20-640 | Poland |
| Specjalistyczny Osrodek Leczniczo Badawczy | Recruiting | OstrĂ³da | 14-100 | Poland |
| Lecran - Centrum Opieki Nad Ranami-Kunickiego | Recruiting | Wroclaw | 54-616 | Poland |
| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D003668 | Pressure Ulcer |
| D002056 | Burns |
| D004820 | Epidermolysis Bullosa |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014947 | Wounds and Injuries |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D012872 | Skin Diseases, Vesiculobullous |
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