Diabetic Foot Ulcer, Pressure Ulcer, Venous Leg Ulcer
Conditions
Brief summary
An open, non-comparative, multicenter investigation to evaluate the safety and performance of Exufiber Ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds
Detailed description
The overall objective of this post market clinical follow-up (PMCF) investigation is to confirm performance and safety of the Exufiber Ag+ dressing in medium to high exuding chronic wounds, with Mepilex Border Flex as the secondary dressing, when used in accordance with the Instructions for Use.
Interventions
DEVICEExufiberAG+
confirm performance and safety of the Exufiber Ag+ dressing in medium to high exuding chronic wounds
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluate the safety and performance of Exufiber Ag+ in medium to high exuding chronic wounds | 28 Days | open, non-comparative, multicenter investigation |
Countries
United States
Outcome results
None listed