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

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

• Status: Terminated
• Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer; Pressure Ulcer
• Intervention / Treatment: Device: ExufiberAG+

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Center for Clinical Research
  • Ohio
    • Miamisburg, Ohio, United States, 45342
      • Sycamore Wound Care and Hyperbaric Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): November 29, 2022
• Study Completion (Actual): November 29, 2022

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Varicose Veins; Diabetic Foot; Foot Ulcer; Ulcer; Leg Ulcer; Varicose Ulcer; Pressure Ulcer
• Other Study ID Numbers: ExufiberAg+02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes