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The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Suprasorb® A + Ag wound dressing and rope, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with use of Suprasorb® A + Ag wound dressing and rope within the certified indications and under the conditions of routine use.
This clinical investigation will be conducted as 3 weeks, multicentre, open, single-arm cohort study on patients presenting wounds at risk of infection or infected wounds. All wounds of the included patients will be treated with Suprasorb® A +Ag Antimicrobial Calcium Alginate Wound Dressings (and Suprasorb® A + Ag Antimicrobial Calcium Packing Rope - if required by the depth of the wound).
At inclusion visit (V1, day 0), interim visit (V2, after 10 days ±3 days) and termination visit (V3 after 21 days ±3 days or earlier; as soon as the wound is epithelialized completely) patients will have clinical examination and wound area measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| wounds at risk of infection | Ideally 71 patients with wounds at risk of infection (W.A.R. Score ≥ 3) to be included. |
| |
| infected wounds | Ideally 28 patients with infected wounds (TILI Score ≥ 5) to be included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suprasorb® A + Ag wound dressing and rope | Device | Suprasorb® A + Ag Antimicrobial Calcium Alginate Wound Dressings / Packing Rope are soft, conformable wound coverings with a high mannuronic acid content (mass per unit area ≥100 g/m2). The silver impregnated calcium alginate fibres react with wound exudate or blood to form a gel which creates a moist wound environment. The silver contained in the wound dressing has broad antimicrobial activity, including against MRSA and VRE. Antimicrobial action (>3 log steps) associated with the ionic silver from the silver alginate fibres (1.5%) is observed in vitro after just 24 h and this remains stable for up to seven days |
| Measure | Description | Time Frame |
|---|---|---|
| Combined endpoint | Change of local wound infection after 21 days of treatment with Suprasorb® A+Ag in wounds at risk of infection and infected wounds, assessed by "Therapeutical Index for Local Infections (TILI)" score. The investigator will evaluate six indirect parameters of the local wound infection:
Each present parameter will be assigned 1 point. All points will be summed up and the final score (min 0, max 6) will define the local infection status. In case the score is ≥ 5, wound is deemed to be locally infected. | 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of device-related adverse events (device safety) | Frequency and character severity of device deficiencies (DDs), adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), serious adverse device effects (SADEs) and incidents. | 20 months |
| Change of wound bed condition, defined by the combination of the following parameters: |
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Inclusion Criteria:
Age ≥ 18 years
Patient is legally capable
Presence of a heavily exuding wound
Presence of one of the following wounds:
Infected wound (TILI Score ≥ 5) or a wound with risk of infection (W.A.R. Score ≥ 3)
Wound area between 4 and 100 cm2
It must be possible to display the entire wound area on one photo from a distance of 25-30 cm
Patient has signed a written Informed Consent
Exclusion Criteria:
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The main target population of this investigation are older people. Patients will be enrolled with wounds at risk of infection and infected wounds which are: heavily exuding, superficial or deep, for:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Feldkamp, Dr. | Lohmann & Rauscher | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Practice | Bolesławiec | Poland | ||||
| Private Practice |
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|
|
| 20 months |
| Change in wound-related pain, with a separate assessment of: |
| 20 months |
| Change in wound-related quality of life | Change in wound-related quality of life, measured by Wound QoL Questionnaire | 20 months |
| User satisfaction | User satisfaction, assessed by the questionnaire | 20 months |
| Mean frequency of dressing changes | Mean frequency of dressing changes | 20 months |
| Mean time of treatment | Mean time of treatment | 20 months |
| Krakow |
| Poland |
| Private Practice | Lodz | Poland |
| Private Practice | Ostróda | Poland |
| Private Practice | Oświęcim | Poland |
| Private Practice | Pabianice | Poland |
| Private Practice | Swidnica | Poland |
| Private Practice | Wroclaw | Poland |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D014647 | Varicose Ulcer |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D014947 | Wounds and Injuries |
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