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

Not Applicable

Terminated

• Conditions: Pressure Ulcer; Venous Leg Ulcer; Diabetic Foot Ulcer
• Interventions: Device: ExufiberAG+

• Registration Number: NCT05494450
• Lead Sponsor: Molnlycke Health Care AB

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.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Primary Completion: 2022-11-29
• Study Completion: 2022-11-29
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ExufiberAG+02	ExufiberAG+	using ExufiberAG as the primary dressing on medium to high exuding chronic wounds.

Primary Outcome Measures

Name	Time	Method
evaluate the safety and performance of Exufiber Ag+ in medium to high exuding chronic wounds	28 Days	open, non-comparative, multicenter investigation

Trial Locations

Locations (2)

Center for Clinical Research; 🇺🇸 San Francisco, California, United States

Sycamore Wound Care and Hyperbaric Center; 🇺🇸 Miamisburg, Ohio, United States