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

NCT05494450 | Terminated FDA Device

• 1 other identifier: ExufiberAg+02
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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

Conditions

Pressure Ulcer; Diabetic Foot Ulcer; Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• evaluate the safety and performance of Exufiber Ag+ in medium to high exuding chronic wounds

  open, non-comparative, multicenter investigation

  28 Days

Study Arms (1)

ExufiberAG+02

OTHER

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

Device: ExufiberAG+

Interventions

ExufiberAG+ DEVICE

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

ExufiberAG+02

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (2)

Center for Clinical Research

San Francisco, California, 94115, United States

Location

Sycamore Wound Care and Hyperbaric Center

Miamisburg, Ohio, 45342, United States

Location

MeSH Terms

Conditions

Pressure Ulcer; Diabetic Foot; Varicose Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: January 1, 2022
• Primary Completion: November 29, 2022
• Study Completion: November 29, 2022
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)