DURAFIBER Ag Post-Market Clinical Follow-Up

A Prospective, Open, Non-Comparative Multicentre Study to Evaluate a Fibrous Silver Dressing (DURAFIBER™ Ag) in the Treatment of Moderate to Highly Exuding Venous Leg Ulcers

The aim of the study is to evaluate the performance of DURAFIBER Ag and to assess how many bacteria are present in infected wounds over an 8 week period.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries; Infection; Venous Leg Ulcer
• Intervention / Treatment: Device: DURAFIBER Ag

Detailed Description

The aim of the study is to evaluate the performance of DURAFIBER Ag and to assess how many bacteria are present in infected wounds over an 8 week period.

DURAFIBER Ag is a commercially available absorbent, non-woven, silver-containing antimicrobial dressing for use on a variety of exuding wounds and is widely used in routine clinical practice within the UK.

The primary outcome will be the quantitative reduction in bacterial load, based on a wound biopsy, from baseline to week 8. Secondary objectives will include the quantitative reduction in bacterial load, based on biopsy, from initial assessment to week 4, and the semi-quantitative reduction in bacterial load, based on swab analysis, from baseline to weeks 4 and 8. Additionally dressing performance measures will be assessed as well as all adverse events and device deficiencies.

In total 20 evaluable participants with an infected venous leg ulcer will be recruited into the trial. All participants will have their wound dressed using DURAFIBER Ag and will be followed-up for 8 weeks.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Ashington, United Kingdom, NE63 0HP
    • Northumbria Healthcare NHS Foundation Trust
  • Bradford, United Kingdom, BD9 6RJ
    • Bradford Teaching Hospitals NHS Foundation Trust
  • Newcastle, United Kingdom, NE3 3HD
    • Newcastle upon Tyne Hospitals NHS Foundation Trust
  • East Yorkshire
    • Hull, East Yorkshire, United Kingdom, HU3 2JZ
      • Hull & East Riding Hospitals NHS Trust
  • Lancashire
    • Preston, Lancashire, United Kingdom, PR2 8DW
      • Lancashire Care NHS Foundation Trust
  • South Yorkshire
    • Barnsley, South Yorkshire, United Kingdom, S75 2EP
      • Barnsley Hospital NHS Foundation Trust
  • Wales
    • Cardiff, Wales, United Kingdom, CF14 4XW
      • Cardiff & Vale University Healthcare Board

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: Inclusion Criteria to be confirmed at the initial assessment

• The subject or must provide written informed consent.
• Subjects must be at least eighteen (18) years of age.
• Willing and able to make all required study visits.
• Able to follow instructions.
• Subjects must have a VLU, an ankle brachial pressure index (ABPI) taken within the last 28 days of 0.8-1.3, and must be treated with compression therapy.
• The subject must have a wound with an area ≥ 2cm².
• The subject's wound must have moderate or high exudate levels.
• The subject's reference wound must, in the opinion of the Healthcare Professional, show signs of infection warranting treatment with DURAFIBER Ag.
• In the clinician's opinion the subject's wound has an initial bacterial count of > 104 cfu/g (which will be confirmed following the initial wound biopsy).

Inclusion criteria to be confirmed when the biopsy result is recorded:

-The subject's wound has a confirmed initial bacterial count of > 104 cfu/g

Exclusion Criteria:

• Contraindications or hypersensitivity to the use of the DURAFIBER Ag, ancillary products or their components (e.g. known sensitivity to silver).
• Participation in the treatment period of another clinical trial within thirty (30) days of the date of consent.
• Subjects with skin features (e.g. tattoos, skin colour, pre-existing scarring) which, in the opinion of the Investigator, will interfere with the study assessments.
• Subjects receiving topical antimicrobials or oil-based products (such as petrolatum) at the reference wound surface.
• Subjects being treated with immunosuppressive drugs or corticosteroids.
• Subjects who have participated previously in this clinical trial and who have healed or been withdrawn.
• Subjects with a known history of poor compliance with medical treatment.
• Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Antimicrobial Dressing	Device: DURAFIBER Ag; DURAFIBER Ag is a commercially available absorbent, non-woven, silver-containing antimicrobial dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the mean log10 bacterial count in tissue biopsies from baseline to week 8	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in the mean log10 bacterial count from tissue biopsies from baseline to week 4.	4 weeks
The semi-quantitative presence of bacteria, bacteria type and species from the weekly swabs	8 weeks
Change in the number of subjects showing clinical signs of infection from baseline to weeks 4 and 8.	8 weeks

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Investigators: Principal Investigator: Helen Fearnley, Bradford Teaching Hospitals NHS Foundation Trust; Study Chair: Elizabeth Huddleston, PhD, Smith & Nephew - Global Strategy

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 12, 2017
• Primary Completion (ACTUAL): June 19, 2019
• Study Completion (ACTUAL): June 19, 2019

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (ACTUAL): September 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Wounds and Injuries; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: CT1701DUR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No