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

Stopped early · Not applicable

Conditions studied: Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer

In brief

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

Key facts

Study ID

NCT05494450

Run by

Molnlycke Health Care AB

People needed

46

Starts

2022-01-01

Expected to finish

2022-11-29

Last updated by the study team

2023-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Center for Clinical Research — San Francisco, California, United States
• Sycamore Wound Care and Hyperbaric Center — Miamisburg, Ohio, United States

Full record on ClinicalTrials.gov

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