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This prospective, multicenter, single-arm observational study aims to document the clinical performance and safety of a sterile, bacteria-binding, super-absorbent wound dressing for the intended use in a daily clinical practice. 50 patients (male/female) with superficial wounds of any etiology affecting only epidermis and dermis layer, with one or more clinical signs of infection or at high risk of infection and also high to very high exudate levels will be observed over a period of 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with superficial wounds | A cohort of 50 patients with superficial wounds of any etiology (see inclusion criteria), who need advanced wound care treatment in any case, will be observed over a period of 14 days; the exact duration for each patient depends upon the investigator's assessment. The observation consists of an initial visit, at least one dressing change after max. 7 days and a final visit. Patients will be treated with the CE-marked wound care product. This product is already in general use in the Netherlands and Germany. It is a sterile, bacteria-binding, super-absorbent wound dressing. Apart from the predefined study visits, daily dressing changes in accordance with daily clinical practice are possible. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with persisting infections will be documented in a standardized Case Report Form (CRF). | Symptoms such as odor, pain, localized heat and erythema will be assessed by a clinician and documented in four different categories depending on its severity. | 14 days |
| Number of participants with newly developed infections will be documented in a standardized Case Report Form (CRF) | Symptoms such as odor, pain, localized heat and erythema will be assessed by a clinician and documented in four different categories depending on its severity. | 14 days |
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Inclusion Criteria:
Men and women ≥ 18 years old
Written informed consent after patient education to participate in the study
Superficial wounds of any etiology affecting only epidermis and dermis layers
Maximum wound size: 6 x 16cm / 6 x 6cm
Wounds with one or more clinical signs or infection or assessed as at high risk of infection according to the following:
Superficial wounds with high levels of exudate
Exclusion Criteria:
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Patients with superficial wounds of any etiology, that are treated at outpatients' clinic
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| Name | Affiliation | Role |
|---|---|---|
| Nicky Ivins | Welsh Wound Innovation Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Welsh Wound Innovation Centre | Ynysmaerdy | Rhondda Cynon Taf | CF728UX | United Kingdom |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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