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DURAFIBER Ag Post-Market Clinical Follow-Up

Primary Purpose

Wounds and Injuries, Venous Leg Ulcer, Infection

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
DURAFIBER Ag
Sponsored by
Smith & Nephew, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds and Injuries

Eligibility Criteria

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

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  • Subjects who have participated previously in this clinical trial and who have healed or been withdrawn.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.

Sites / Locations

  • Hull & East Riding Hospitals NHS Trust
  • Lancashire Care NHS Foundation Trust
  • Barnsley Hospital NHS Foundation Trust
  • Cardiff & Vale University Healthcare Board
  • Northumbria Healthcare NHS Foundation Trust
  • Bradford Teaching Hospitals NHS Foundation Trust
  • Newcastle Upon Tyne Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Antimicrobial Dressing

Outcomes

Primary Outcome Measures

Change in the mean log10 bacterial count in tissue biopsies from baseline to week 8

Secondary Outcome Measures

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

Full Information

First Posted
September 7, 2017
Last Updated
February 28, 2022
Sponsor
Smith & Nephew, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03277131
Brief Title
DURAFIBER Ag Post-Market Clinical Follow-Up
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
June 19, 2019 (Actual)
Study Completion Date
June 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries, Venous Leg Ulcer, Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Antimicrobial Dressing
Intervention Type
Device
Intervention Name(s)
DURAFIBER Ag
Intervention Description
DURAFIBER Ag is a commercially available absorbent, non-woven, silver-containing antimicrobial dressing
Primary Outcome Measure Information:
Title
Change in the mean log10 bacterial count in tissue biopsies from baseline to week 8
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in the mean log10 bacterial count from tissue biopsies from baseline to week 4.
Time Frame
4 weeks
Title
The semi-quantitative presence of bacteria, bacteria type and species from the weekly swabs
Time Frame
8 weeks
Title
Change in the number of subjects showing clinical signs of infection from baseline to weeks 4 and 8.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Fearnley
Organizational Affiliation
Bradford Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Huddleston, PhD
Organizational Affiliation
Smith & Nephew - Global Strategy
Official's Role
Study Chair
Facility Information:
Facility Name
Hull & East Riding Hospitals NHS Trust
City
Hull
State/Province
East Yorkshire
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Lancashire Care NHS Foundation Trust
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR2 8DW
Country
United Kingdom
Facility Name
Barnsley Hospital NHS Foundation Trust
City
Barnsley
State/Province
South Yorkshire
ZIP/Postal Code
S75 2EP
Country
United Kingdom
Facility Name
Cardiff & Vale University Healthcare Board
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Northumbria Healthcare NHS Foundation Trust
City
Ashington
ZIP/Postal Code
NE63 0HP
Country
United Kingdom
Facility Name
Bradford Teaching Hospitals NHS Foundation Trust
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Newcastle Upon Tyne Hospitals NHS Foundation Trust
City
Newcastle
ZIP/Postal Code
NE3 3HD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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DURAFIBER Ag Post-Market Clinical Follow-Up

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