N/A
Completed N=248
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
Source: ClinicalTrials.gov NCT02921750 ↗Enrolled (actual)
248
Serious AEs
5.2%
Results posted
Nov 2020
Primary outcomePrimary: Wound Area Change (%) — -49.7; -42.4 relative wound area change in percentage — p=0.093
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Area Change (%) |
-49.7; -42.4 | 0.093 |
| SECONDARY Wound Area Change (cm2) |
-4.64; -3.48 | — |
| SECONDARY Linear Advance of Wound Margin |
0.008; 0.007 | — |
| SECONDARY Pain During Debridement |
25.8; 26.9 | — |
| SECONDARY Pain at Dressing Removal |
16.3; 16.9 | — |
| SECONDARY Percentage of Clinicians of Opinion 'Very Good' for Dressing Features |
58.4; 57.5; 48.7; 35.9; 48.0; 40.8 | — |
| SECONDARY Percentage of Clinicians of Opinion 'Does Not Adhere' Related to Dressing Features |
44.2; 31.1; 72.0; 52.1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02921750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.