Prospective, Multicenter, Observational Study to Evaluate the Clinical Performance of a Sterile, Bacteria-binding, Super-absorbent Wound Dressing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- BSN Medical GmbH
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Number of patients with persisting infections will be documented in a standardized Case Report Form (CRF).
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Number of patients with persisting infections will be documented in a standardized Case Report Form (CRF).
Time Frame: 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)
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported