NCT02921750CompletedNot Applicable
A Randomised Multi-centre Non-inferiority Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin
Molnlycke Health Care AB33 sites in 6 countries248 target enrollmentStarted: October 1, 2016Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 248
- Locations
- 33
- Primary Endpoint
- Wound Area Change (%)
Study Overview
Brief Summary
The investigation is designed as an open, randomized, non-inferiority, multi-centre investigation.
212 evaluable subjects will be randomised. Subjects to be included will suffer from an exuding venous or mixed ulcer of predominantly venous origin. Subjects will either be randomized to Exufiber®Gelling Fibre Dressing or Aquacel®Extra Hydrofiber® Dressing with Strengthening Fibre using, centralized randomization
Detailed Description
Visits are planned for baseline followed by 1, 2, 3, 4 and 6 weeks post treatment. The sub-group of at least 50 subjects will also be followed at week 8, 12, 16, 20, and 24 post treatment or until wound is healed if earlier.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form
- •Both gender ≥18 years old
- •Ulcer moderately or strongly exudative justifying the use of an absorbent dressing
- •(History of compression at least two weeks before inclusion) Deleted in Am.2
- •(Wound covered with slough ≥70%) Deleted in Am.4
- •0.7≤ABPI<1.3
- •Ulcer duration 6 weeks to 60 months
- •Ulcer size 3 cm2-100 cm2
- •Target ulcer at least 3 cm away from any other lesion
Exclusion Criteria
- •Known allergy/hypersensitivity to the dressings
- •Pregnant or breastfeeding
- •Circumferential wounds (the entire wound should be able to be captured on a single image/photo)
- •Subjects who will have problems following the protocol
- •Subjects included in other ongoing clinical investigation evaluating wound dressings at present or during the past 30 days
- •Patient with a systemic infection not controlled by suitable antibiotic treatment
- •Clinically infected wound according to the judgement of the investigator (heat, pain, swelling, redness or purulent secretion)
- •Wound covered with black necrosis
- •Malignant wound degeneration
- •Current treatment with radiotherapy, chemotherapy, immunosuppressant drugs or high doses of oral corticosteroids if any
- •Subject with deep vein thrombosis within 3 months prior to inclusion
Arms & Interventions
Dressing Exufiber®Gelling Fibre Dressing
Experimental
will receive dressing Exufiber®
Intervention: Exufiber Gelling Fibre Dressing (Device)
Dressing Aquacel®ExtraHydrofiber®Dressing with Strengthenin
Active Comparator
Will receive Aquacel®Extra™
Intervention: Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre (Device)
Outcomes
Primary Outcomes
Wound Area Change (%)
Time Frame: 6 weeks
The primary endpoint was to measure relative reduction of wound area (%) from baseline to end of investigation (up to 6 weeks measured by the validated system PictZar on the photos taken after debridement at week 0, week 4, and week 6 (or final visit if healed earlier)
Secondary Outcomes
- Pain at Dressing Removal(6 weeks)
- Percentage of Clinicians of Opinion 'Very Good' for Dressing Features(6 weeks)
- Percentage of Clinicians of Opinion 'Does Not Adhere' Related to Dressing Features(6 weeks)
- Wound Area Change (cm2)(6 weeks)
- Linear Advance of Wound Margin(6 weeks)
- Pain During Debridement(6 weeks)
Investigators
Study Sites (33)
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