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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Device: Exufiber Gelling Fibre Dressing
* Device: Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre


Participation Criteria
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Eligibility Criteria
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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 Dry wounds 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dressing Exufiber®Gelling Fibre Dressing<br>will receive dressing Exufiber® | Device: Exufiber Gelling Fibre Dressing<br>* Gelling fibre dressing<br>|
| Active Comparator: Dressing Aquacel®ExtraHydrofiber®Dressing with Strengthenin<br>Will receive Aquacel®Extra™ | Device: Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre<br>* Hydrofiber® Dressing with Strengthening Fibre<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Area Change (%) | 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) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Area Change (cm2) | The secondary endpoint was to measure relative reduction of wound area (cm2) 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) | 6 weeks | 
| Linear Advance of Wound Margin | Linear advance of the wound margin according to Gilman's formula (G= [(A0-An) / ((P0+Pn) / 2)] / Time) was calculated and evaluated using the validated system PictZar on the photos taken after debridement. The values represent wound margin advanced inwards over time (i.e., reduction in perimeter) presented in cm/day. | 6 weeks | 
| Pain During Debridement | Pain was reported by patients and measured by Visual Analogue Scale (VAS) 0-100mm, where 0=is no pain, 100=is worst pain ever. | 6 weeks | 
| Pain at Dressing Removal | Pain was reported by patients and measured by Visual Analogue Scale (VAS) 0-100mm, where 0=is no pain, 100=is worst pain ever. | 6 weeks | 
| Percentage of Clinicians of Opinion 'Very Good' for Dressing Features | Clinician reported outcomed by means a questionnaire was used to capture opinions related to the two dressing types. Reply alternatives varied between very poor, poor, good, very good. Results reported as 'very good' are presented as a percentage based on all follow-up visits aggregated. | 6 weeks | 
| Percentage of Clinicians of Opinion 'Does Not Adhere' Related to Dressing Features | Clinician reported outcomed by means a questionnaire was used to capture opinions related to the two dressing types. Reply alternatives varied between does not adhere, adhere a little, adhere a lot. Results reported as 'does not adhere' are presented as a percentage based on all follow-up visits aggregated. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound reduction wound healing, venous ulcers