Wounds
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
BSN Medical GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * Wounds assessed as critically colonized with malodour, abnormal tissue or absence of viable tissue, excessive or increased serous exudate, possible extension of wound dimensions and no sign of a healing process and/or * Wounds with one or more historical episodes of topical infection and/or * Wounds assessed as at a high risk of infection on other grounds by the investigator. * Superficial wounds with high levels of exudate
Exclusion criteria
* Not willing to sign or incapable of signing an informed consent form * Known allergy or sensitivity to one of the dressing components * Pregnancy or lactation * Subject is participating in another clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with persisting infections will be documented in a standardized Case Report Form (CRF). | 14 days | 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. |
| Number of participants with newly developed infections will be documented in a standardized Case Report Form (CRF) | 14 days | 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. |
Countries
United Kingdom
Outcome results
None listed