Wounds and InjuriesNCT03277131
DURAFIBER Ag Post-Market Clinical Follow-Up
A study testing DURAFIBER Ag in people with Wounds and Injuries and Venous Leg Ulcer, run by Smith & Nephew, Inc. at 7 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries, Venous Leg Ulcer, Infection
- What is being tested?
- DURAFIBER Ag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- 12 Dec 2017to 19 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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- Subjects who have participated previously in this clinical trial and who have healed or been withdrawn.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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Northumbria Healthcare NHS Foundation Trust
Ashington, NE63 0HP
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, S75 2EP
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD9 6RJ
Cardiff & Vale University Healthcare Board
Cardiff, Wales, CF14 4XW
Hull & East Riding Hospitals NHS Trust
Hull, East Yorkshire, HU3 2JZ
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle, NE3 3HD
Lancashire Care NHS Foundation Trust
Preston, Lancashire, PR2 8DW
About this study
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
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.
Read the 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.
- Conditions
- Wounds and Injuries, Venous Leg Ulcer, Infection
- Being tested
- DURAFIBER Ag
- Medical subject headings
- Wounds and Injuries, Varicose Ulcer, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DURAFIBER AgDevice
DURAFIBER Ag is a commercially available absorbent, non-woven, silver-containing antimicrobial dressing
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Antimicrobial Dressing Receives: Device: DURAFIBER Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the mean log10 bacterial count in tissue biopsies from baseline to week 8
Measured: 8 weeks
Secondary outcomes (3)
Change in the mean log10 bacterial count from tissue biopsies from baseline to week 4.
Measured: 4 weeks
The semi-quantitative presence of bacteria, bacteria type and species from the weekly swabs
Measured: 8 weeks
Change in the number of subjects showing clinical signs of infection from baseline to weeks 4 and 8.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start12 Dec 2017
- Primary completion19 Jun 2019
- Study completion19 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helen Fearnley, Principal investigator, Bradford Teaching Hospitals NHS Foundation TrustElizabeth Huddleston, PhD, Study chair, Smith & Nephew - Global Strategy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277131
- Sponsor's protocol ID
- CT1701DUR
- Status last verified
- Jun 2020
- First submitted
- 7 Sep 2017
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03277131
- Acronym / sponsor ID
- CT1701DUR
- Conditions
- Wounds and Injuries, Venous Leg Ulcer, Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: DURAFIBER AgAntimicrobial Dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DURAFIBER AgDURAFIBER Ag is a commercially available absorbent, non-woven, silver-containing antimicrobial dressing | Device | 1 |
Primary outcome
Change in the mean log10 bacterial count in tissue biopsies from baseline to week 8
Time frame: 8 weeks
3 secondary outcomes
Change in the mean log10 bacterial count from tissue biopsies from baseline to week 4.
Time frame: 4 weeks
The semi-quantitative presence of bacteria, bacteria type and species from the weekly swabs
Time frame: 8 weeks
Change in the number of subjects showing clinical signs of infection from baseline to weeks 4 and 8.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Fearnley principal investigator
Bradford Teaching Hospitals NHS Foundation Trust
Elizabeth Huddleston, PhD study chair
Smith & Nephew - Global Strategy
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DURAFIBER Ag in people with Wounds and Injuries and Venous Leg Ulcer, run by Smith & Nephew, Inc. at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the mean log10 bacterial count in tissue biopsies from baseline to week 8 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.