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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

NCT ID: NCT02921750

Last Updated: 2020-11-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-11-27

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.

Conditions

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Venous Leg Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dressing Exufiber®Gelling Fibre Dressing

will receive dressing Exufiber®

Group Type EXPERIMENTAL

Exufiber Gelling Fibre Dressing

Intervention Type DEVICE

Gelling fibre dressing

Dressing Aquacel®ExtraHydrofiber®Dressing with Strengthenin

Will receive Aquacel®Extra™

Group Type ACTIVE_COMPARATOR

Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre

Intervention Type DEVICE

Hydrofiber® Dressing with Strengthening Fibre

Interventions

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Exufiber Gelling Fibre Dressing

Gelling fibre dressing

Intervention Type DEVICE

Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre

Hydrofiber® Dressing with Strengthening Fibre

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Molnlycke Health Care AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bo Joergensen, MD

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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St. Ann University Hospital Dep of Dermatovenereology

Brno, , Czechia

Site Status

Hospital Jihlava

Jihlava, , Czechia

Site Status

Regional hospital Pardubice Dermatology Department

Pardubice, , Czechia

Site Status

Fakultní nemocnice Královské Vinohrady (FNKV)Department of General Surgery 3

Prague, , Czechia

Site Status

General University Hospital in Prague

Prague, , Czechia

Site Status

Diabetologie

Soběslav, , Czechia

Site Status

Salvatella LTD

Třinec, , Czechia

Site Status

Bispebjerg Hospital

Copenhagen, Copenhagen NV, Denmark

Site Status

Hôpital Michallon

Grenoble, , France

Site Status

Groupe Hospitalier

La Rochelle, , France

Site Status

Hospital Géneral du Mans

Le Mans, , France

Site Status

Clinique du Parc Unité de Cicatrisation

Lyon, , France

Site Status

CHU Nantes

Nantes, , France

Site Status

Clinique Pasteur

Toulouse, , France

Site Status

Wundzentrum Augsburg

Augsburg, , Germany

Site Status

WundZentrum Dortmund

Dortmund, , Germany

Site Status

WundZentrum Düsseldorf

Düsseldorf, , Germany

Site Status

Universitätsklinikum Erlangen

Erlangen, , Germany

Site Status

Venenzentrum Freiburg

Freiburg im Breisgau, , Germany

Site Status

Paracelsus-Klinik am Silbersee

Hanover, , Germany

Site Status

University Hospital Schleswig-Holstein

Kiel, , Germany

Site Status

Johannes-Gutenberg-Universität Mainz

Mainz, , Germany

Site Status

WundZentrum München Nord

München, , Germany

Site Status

WundZentrum Ulm

Ulm, , Germany

Site Status

Usługi Medyczne PRO-MED Sp. z o.o., ul.

Gliwice, , Poland

Site Status

Niepubliczny Zakład Opieki Zdrowotnej "GAM-MED", ul.

Kielce, , Poland

Site Status

Niepubliczny Zakład Opieki Zdrowotnej "Mikomed", ul.

Lodz, , Poland

Site Status

Medical Hair & Esthetic, ul.

Lublin, , Poland

Site Status

Lund university Hospital,

Lund, , Sweden

Site Status

Avdelningen för kliniska prövningar, Universitetssjukhuset Örebro

Örebro, , Sweden

Site Status

Skellefteå Lasarett

Skellefteå, , Sweden

Site Status

Karolinska Trial Alliance, Prim

Stockholm, , Sweden

Site Status

Södersjukhuset (Sårcentrum)

Stockholm, , Sweden

Site Status

Countries

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Czechia Denmark France Germany Poland Sweden

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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CHEXU03

Identifier Type: -

Identifier Source: org_study_id