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:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT05494450
Eligibility Criteria:
Inclusion Criteria:
1. Signed Informed Consent Form
2. Patient aged ≥18 years old
3. Patient with moderate to high exuding chronic wound (PU (stage II-IV), VLU or DFU)
4. Patient with target wound that is a shallow to deep wound or cavity
5. Patient with target wound that is ≥ 4 weeks in age
6. Patient with target wound that is ≥ 8 cm2
Exclusion Criteria:
1. Patient is contraindicated for the dressing according to product labeling
2. Known allergy/hypersensitivity to any of the components of the investigation products
3. Pregnancy/lactating female
4. Patient with spreading soft tissue infection/cellulitis in the wound (as judged by the Investigator)
5. Patient with known immunodeficiency
6. Patient taking systemic antibiotics
7. Patient with the target wound located on an infected limb and/or interfered by minimal blood flow in the opinion of the Investigator.
8. Patient with the target wound with an unexplored enteric fistula
9. Patient requiring treatment with oxidizing agents such as hypochlorite solutions or hydrogen peroxide
10. Patient who, in the opinion of the Investigator, is not expected to comply with the investigation due to physical and/or mental conditions
11. Patient who was previously enrolled in this investigation
12. Patient participating in other investigations that would preclude the subject from participating in this investigation as judged by the Investigator
13. Patient involved in the planning and conduct of the clinical investigation (applies to all Mölnlycke staff, investigational site staff, and third party vendor)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05494450
Study Brief:
Protocol Section:
NCT05494450