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

NCT02921750 | Completed Results

• 1 other identifier: CHEXU03
• Study Type: interventional
• Target: 248
• Locations: 6 countries
• Sites: 33

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

Conditions

Venous Leg Ulcer

Keywords

wound reduction wound healing, venous ulcers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Wound Area Change (cm2)

  6 weeks

• Linear Advance of Wound Margin

  6 weeks

• Pain During Debridement

  6 weeks

• Pain at Dressing Removal

  6 weeks

• Percentage of Clinicians of Opinion 'Very Good' for Dressing Features

  6 weeks

Other Outcomes (1)

• Percentage of Participants With Healed Wounds

  from baseline to 24 weeks

Study Arms (2)

Dressing Exufiber®Gelling Fibre Dressing

EXPERIMENTAL

will receive dressing Exufiber®

Device: Exufiber Gelling Fibre Dressing

Dressing Aquacel®ExtraHydrofiber®Dressing with Strengthenin

ACTIVE COMPARATOR

Will receive Aquacel®Extra™

Device: Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre

Interventions

Exufiber Gelling Fibre Dressing DEVICE

Gelling fibre dressing

Dressing Exufiber®Gelling Fibre Dressing

Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre DEVICE

Hydrofiber® Dressing with Strengthening Fibre

Dressing Aquacel®ExtraHydrofiber®Dressing with Strengthenin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• (Wound covered with slough ≥70%) Deleted in Am.4
• ≤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

You may not qualify if:

• 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

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (33)

St. Ann University Hospital Dep of Dermatovenereology

Brno, 656 91, Czechia

Location

Hospital Jihlava

Jihlava, 58601, Czechia

Location

Regional hospital Pardubice Dermatology Department

Pardubice, 53203, Czechia

Location

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

Prague, 10034, Czechia

Location

General University Hospital in Prague

Prague, 128 08, Czechia

Location

Diabetologie

Soběslav, 39201, Czechia

Location

Salvatella LTD

Třinec, 739 61, Czechia

Location

Bispebjerg Hospital

Copenhagen, Copenhagen NV, 2200, Denmark

Location

Hôpital Michallon

Grenoble, 38043, France

Location

Groupe Hospitalier

La Rochelle, 17019, France

Location

Hospital Géneral du Mans

Le Mans, 72000, France

Location

Clinique du Parc Unité de Cicatrisation

Lyon, 69006, France

Location

CHU Nantes

Nantes, 44000, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Wundzentrum Augsburg

Augsburg, 86152, Germany

Location

WundZentrum Dortmund

Dortmund, 44137, Germany

Location

WundZentrum Düsseldorf

Düsseldorf, Germany

Location

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

Location

Venenzentrum Freiburg

Freiburg im Breisgau, 79008, Germany

Location

Paracelsus-Klinik am Silbersee

Hanover, Germany

Location

University Hospital Schleswig-Holstein

Kiel, 24105, Germany

Location

Johannes-Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

WundZentrum München Nord

München, 80939, Germany

Location

WundZentrum Ulm

Ulm, 89077, Germany

Location

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

Gliwice, 44-109, Poland

Location

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

Kielce, 25-315, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej "Mikomed", ul.

Lodz, 94-238, Poland

Location

Medical Hair & Esthetic, ul.

Lublin, 20-844, Poland

Location

Lund university Hospital,

Lund, 22185, Sweden

Location

Avdelningen för kliniska prövningar, Universitetssjukhuset Örebro

Örebro, 70185, Sweden

Location

Skellefteå Lasarett

Skellefteå, 931 41, Sweden

Location

Karolinska Trial Alliance, Prim

Stockholm, 113 61, Sweden

Location

Södersjukhuset (Sårcentrum)

Stockholm, 118 83, Sweden

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Maria Åberg Håkansson
• Organization: Mölnlycke Health Care

maria.aberghakansson@molnlycke.com

+46 31722 3000

Study Officials

• Bo Joergensen, MD

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: October 3, 2016
• Study Start: October 1, 2016
• Primary Completion: November 27, 2019
• Study Completion: November 27, 2019
• Last Updated: November 2, 2020
• Results First Posted: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6); DK (1); PL (4); SE (5); CZ (7); DE (10)