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

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05494450
• Other study ID #: ExufiberAg+02
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: November 29, 2022

Study information

• Verified date: April 2023
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: November 29, 2022
• Est. primary completion date: November 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Leg Ulcer
• Pressure Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• ExufiberAG+
confirm performance and safety of the Exufiber Ag+ dressing in medium to high exuding chronic wounds

Locations

Country	Name	City	State
United States	Sycamore Wound Care and Hyperbaric Center	Miamisburg	Ohio
United States	Center for Clinical Research	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the safety and performance of Exufiber Ag+ in medium to high exuding chronic wounds	open, non-comparative, multicenter investigation	28 Days