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
Primary Purpose
Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ExufiberAG+
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcer
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)
Sites / Locations
- Center for Clinical Research
- Sycamore Wound Care and Hyperbaric Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ExufiberAG+02
Arm Description
using ExufiberAG as the primary dressing on medium to high exuding chronic wounds.
Outcomes
Primary Outcome Measures
evaluate the safety and performance of Exufiber Ag+ in medium to high exuding chronic wounds
open, non-comparative, multicenter investigation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05494450
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision secondary to data collection
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
November 29, 2022 (Actual)
Study Completion Date
November 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ExufiberAG+02
Arm Type
Other
Arm Description
using ExufiberAG as the primary dressing on medium to high exuding chronic wounds.
Intervention Type
Device
Intervention Name(s)
ExufiberAG+
Intervention Description
confirm performance and safety of the Exufiber Ag+ dressing in medium to high exuding chronic wounds
Primary Outcome Measure Information:
Title
evaluate the safety and performance of Exufiber Ag+ in medium to high exuding chronic wounds
Description
open, non-comparative, multicenter investigation
Time Frame
28 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Center for Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Sycamore Wound Care and Hyperbaric Center
City
Miamisburg
State/Province
Ohio
ZIP/Postal Code
45342
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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