Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT02662218
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02662218
Study Brief:
Protocol Section:
NCT02662218