Status:
COMPLETED
DURAFIBER Ag Post-Market Clinical Follow-Up
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Wounds and Injuries
Venous Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
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 abso...
Eligibility Criteria
Inclusion
- 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
- 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- Subjects who have participated previously in this clinical trial and who have healed or been withdrawn.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.
Key Trial Info
Start Date :
December 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03277131
Start Date
December 12 2017
End Date
June 19 2019
Last Update
March 2 2022
Active Locations (7)
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1
Hull & East Riding Hospitals NHS Trust
Hull, East Yorkshire, United Kingdom, HU3 2JZ
2
Lancashire Care NHS Foundation Trust
Preston, Lancashire, United Kingdom, PR2 8DW
3
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, United Kingdom, S75 2EP
4
Cardiff & Vale University Healthcare Board
Cardiff, Wales, United Kingdom, CF14 4XW