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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
Molnlycke Health Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

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

First Posted
August 8, 2022
Last Updated
April 4, 2023
Sponsor
Molnlycke Health Care AB
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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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