Clinical trial NCT02921750: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Keywords: wound reduction wound healing, venous ulcers
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2016-10-03
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form
2. Both gender ≥18 years old
3. Ulcer moderately or strongly exudative justifying the use of an absorbent dressing
4. (History of compression at least two weeks before inclusion) Deleted in Am.2
5. (Wound covered with slough ≥70%) Deleted in Am.4
6. 0.7≤ABPI\<1.3
7. Ulcer duration 6 weeks to 60 months
8. Ulcer size 3 cm2-100 cm2
9. Target ulcer at least 3 cm away from any other lesion

Exclusion Criteria:

1. Known allergy/hypersensitivity to the dressings
2. Pregnant or breastfeeding
3. Circumferential wounds (the entire wound should be able to be captured on a single image/photo)
4. Subjects who will have problems following the protocol
5. Subjects included in other ongoing clinical investigation evaluating wound dressings at present or during the past 30 days
6. Patient with a systemic infection not controlled by suitable antibiotic treatment
7. Clinically infected wound according to the judgement of the investigator (heat, pain, swelling, redness or purulent secretion)
8. Wound covered with black necrosis
9. Dry wounds
10. Malignant wound degeneration
11. Current treatment with radiotherapy, chemotherapy, immunosuppressant drugs or high doses of oral corticosteroids if any
12. Subject with deep vein thrombosis within 3 months prior to inclusion

Primary outcomes:
measure: Wound Area Change (%)
timeFrame: 6 weeks
Secondary outcomes:
measure: Wound Area Change (cm2)
timeFrame: 6 weeks
measure: Linear Advance of Wound Margin
timeFrame: 6 weeks
measure: Pain During Debridement
timeFrame: 6 weeks
measure: Pain at Dressing Removal
timeFrame: 6 weeks
measure: Percentage of Clinicians of Opinion 'Very Good' for Dressing Features
timeFrame: 6 weeks
measure: Percentage of Clinicians of Opinion 'Does Not Adhere' Related to Dressing Features
timeFrame: 6 weeks
Other outcomes:
measure: Percentage of Participants With Healed Wounds
timeFrame: from baseline to 24 weeks
Locations:
city: Brno
country: Czechia
facility: St. Ann University Hospital Dep of Dermatovenereology
city: Jihlava
country: Czechia
facility: Hospital Jihlava
city: Pardubice
country: Czechia
facility: Regional hospital Pardubice Dermatology Department
city: Prague
country: Czechia
facility: Fakultní nemocnice Královské Vinohrady (FNKV)Department of General Surgery 3
city: Prague
country: Czechia
facility: General University Hospital in Prague
city: Sobeslav
country: Czechia
facility: Diabetologie
city: Třinec
country: Czechia
facility: Salvatella LTD
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen NV
city: Grenoble
country: France
facility: Hôpital Michallon
city: La Rochelle
country: France
facility: Groupe Hospitalier
city: Le Mans
country: France
facility: Hospital Géneral du Mans
city: Lyon
country: France
facility: Clinique du Parc Unité de Cicatrisation
city: Nantes
country: France
facility: CHU Nantes
city: Toulouse
country: France
facility: Clinique Pasteur
city: Augsburg
country: Germany
facility: Wundzentrum Augsburg
city: Dortmund
country: Germany
facility: WundZentrum Dortmund
city: Düsseldorf
country: Germany
facility: WundZentrum Düsseldorf
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Freiburg
country: Germany
facility: Venenzentrum Freiburg
city: Hannover
country: Germany
facility: Paracelsus-Klinik am Silbersee
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein
city: Mainz
country: Germany
facility: Johannes-Gutenberg-Universität Mainz
city: München
country: Germany
facility: WundZentrum München Nord
city: Ulm
country: Germany
facility: WundZentrum Ulm
city: Gliwice
country: Poland
facility: Usługi Medyczne PRO-MED Sp. z o.o., ul.
city: Kielce
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej "GAM-MED", ul.
city: Lublin
country: Poland
facility: Medical Hair & Esthetic, ul.
city: Łódź
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej "Mikomed", ul.
city: Lund
country: Sweden
facility: Lund university Hospital,
city: Skellefteå
country: Sweden
facility: Skellefteå Lasarett
city: Stockholm
country: Sweden
facility: Karolinska Trial Alliance, Prim
city: Stockholm
country: Sweden
facility: Södersjukhuset (Sårcentrum)
city: Örebro
country: Sweden
facility: Avdelningen för kliniska prövningar, Universitetssjukhuset Örebro
Study officials:
affiliation: Bispebjerg Hospital
name: Bo Joergensen, MD
role: PRINCIPAL_INVESTIGATOR
References: