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

  • STATUS
    Recruiting
  • days left to enroll
    2
  • participants needed
    102
  • sponsor
    Molnlycke Health Care AB
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Updated on 4 October 2022
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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

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.

Details
Condition Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer
Treatment ExufiberAG+
Clinical Study IdentifierNCT05494450
SponsorMolnlycke Health Care AB
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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