DURAFIBER Ag Post-Market Clinical Follow-Up

NCT03277131 | Completed

• 1 other identifier: CT1701DUR
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 7

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.

Conditions

Wounds and Injuries; Venous Leg Ulcer; Infection

Outcome Measures

Primary Outcomes (1)

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

  8 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

1

EXPERIMENTAL

Antimicrobial Dressing

Device: DURAFIBER Ag

Interventions

DURAFIBER Ag DEVICE

DURAFIBER Ag is a commercially available absorbent, non-woven, silver-containing antimicrobial dressing

1

Eligibility Criteria

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

You may qualify if:

• 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).
• The subject's wound has a confirmed initial bacterial count of \> 104 cfu/g

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (7)

Hull & East Riding Hospitals NHS Trust

Hull, East Yorkshire, HU3 2JZ, United Kingdom

Location

Lancashire Care NHS Foundation Trust

Preston, Lancashire, PR2 8DW, United Kingdom

Location

Barnsley Hospital NHS Foundation Trust

Barnsley, South Yorkshire, S75 2EP, United Kingdom

Location

Cardiff & Vale University Healthcare Board

Cardiff, Wales, CF14 4XW, United Kingdom

Location

Northumbria Healthcare NHS Foundation Trust

Ashington, NE63 0HP, United Kingdom

Location

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, BD9 6RJ, United Kingdom

Location

Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle, NE3 3HD, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries; Varicose Ulcer; Infections

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Helen Fearnley

  Bradford Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Elizabeth Huddleston, PhD

  Smith & Nephew - Global Strategy

  STUDY CHAIR

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: September 7, 2017
• First Posted: September 8, 2017
• Study Start: December 12, 2017
• Primary Completion: June 19, 2019
• Study Completion: June 19, 2019
• Last Updated: March 2, 2022

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7)