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

NCT ID: NCT05494450

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-11-29

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.

Conditions

Pressure Ulcer; Diabetic Foot Ulcer; Venous Leg Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ExufiberAG+02

using ExufiberAG as the primary dressing on medium to high exuding chronic wounds.

Group Type: OTHER

ExufiberAG+

Intervention Type: DEVICE

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

Interventions

ExufiberAG+

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Center for Clinical Research

San Francisco, California, United States

Sycamore Wound Care and Hyperbaric Center

Miamisburg, Ohio, United States

Countries

United States

Other Identifiers

ExufiberAg+02

Identifier Type: -

Identifier Source: org_study_id