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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer

Intervention / Treatment
-----------------
* Device: ExufiberAG+


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent Form Patient aged ≥18 years old Patient with moderate to high exuding chronic wound (PU (stage II-IV), VLU or DFU) Patient with target wound that is a shallow to deep wound or cavity Patient with target wound that is ≥ 4 weeks in age Patient with target wound that is ≥ 8 cm2 Exclusion Criteria: Patient is contraindicated for the dressing according to product labeling Known allergy/hypersensitivity to any of the components of the investigation products Pregnancy/lactating female Patient with spreading soft tissue infection/cellulitis in the wound (as judged by the Investigator) Patient with known immunodeficiency Patient taking systemic antibiotics Patient with the target wound located on an infected limb and/or interfered by minimal blood flow in the opinion of the Investigator. Patient with the target wound with an unexplored enteric fistula Patient requiring treatment with oxidizing agents such as hypochlorite solutions or hydrogen peroxide Patient who, in the opinion of the Investigator, is not expected to comply with the investigation due to physical and/or mental conditions Patient who was previously enrolled in this investigation Patient participating in other investigations that would preclude the subject from participating in this investigation as judged by the Investigator Patient involved in the planning and conduct of the clinical investigation (applies to all Mölnlycke staff, investigational site staff, and third party vendor)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ExufiberAG+02<br>using ExufiberAG as the primary dressing on medium to high exuding chronic wounds. | Device: ExufiberAG+<br>* confirm performance and safety of the Exufiber Ag+ dressing in medium to high exuding chronic wounds<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate the safety and performance of Exufiber Ag+ in medium to high exuding chronic wounds | open, non-comparative, multicenter investigation | 28 Days |