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 (PD-497314)

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

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

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcer
• Intervention / Treatment: Device: Exufiber Gelling Fibre Dressing; Device: Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre

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.

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 656 91
    • St. Ann University Hospital Dep of Dermatovenereology
  • Jihlava, Czechia, 58601
    • Hospital Jihlava
  • Pardubice, Czechia, 53203
    • Regional hospital Pardubice Dermatology Department
  • Prague, Czechia, 128 08
    • General University Hospital in Prague
  • Prague, Czechia, 10034
    • Fakultní nemocnice Královské Vinohrady (FNKV)Department of General Surgery 3
  • Sobeslav, Czechia, 39201
    • Diabetologie
  • Třinec, Czechia, 739 61
    • Salvatella LTD
• Denmark
  • Copenhagen NV
    • Copenhagen, Copenhagen NV, Denmark, 2200
      • Bispebjerg Hospital
• France
  • Grenoble, France, 38043
    • Hôpital Michallon
  • La Rochelle, France, 17019
    • Groupe Hospitalier
  • Le Mans, France, 72000
    • Hospital Géneral du Mans
  • Lyon, France, 69006
    • Clinique du Parc Unité de Cicatrisation
  • Nantes, France, 44000
    • CHU Nantes
  • Toulouse, France, 31076
    • Clinique Pasteur
• Germany
  • Augsburg, Germany, 86152
    • Wundzentrum Augsburg
  • Dortmund, Germany, 44137
    • WundZentrum Dortmund
  • Düsseldorf, Germany
    • WundZentrum Düsseldorf
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen
  • Freiburg, Germany, 79008
    • Venenzentrum Freiburg
  • Hannover, Germany
    • Paracelsus-Klinik am Silbersee
  • Kiel, Germany, 24105
    • University Hospital Schleswig-Holstein
  • Mainz, Germany, 55131
    • Johannes-Gutenberg-Universität Mainz
  • München, Germany, 80939
    • WundZentrum München Nord
  • Ulm, Germany, 89077
    • WundZentrum Ulm
• Poland
  • Gliwice, Poland, 44-109
    • Usługi Medyczne PRO-MED Sp. z o.o., ul.
  • Kielce, Poland, 25-315
    • Niepubliczny Zakład Opieki Zdrowotnej "GAM-MED", ul.
  • Lublin, Poland, 20-844
    • Medical Hair & Esthetic, ul.
  • Łódź, Poland, 94-238
    • Niepubliczny Zakład Opieki Zdrowotnej "Mikomed", ul.
• Sweden
  • Lund, Sweden, 22185
    • Lund university Hospital,
  • Skellefteå, Sweden, 931 41
    • Skellefteå lasarett
  • Stockholm, Sweden, 113 61
    • Karolinska Trial Alliance, Prim
  • Stockholm, Sweden, 118 83
    • Södersjukhuset (Sårcentrum)
  • Örebro, Sweden, 70185
    • Avdelningen för kliniska Prövningar, Universitetssjukhuset Örebro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Healed Wounds	Wound healing assessments were based on blind independent clinical review of photos.	from baseline to 24 weeks

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Bo Joergensen, MD, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): November 27, 2019
• Study Completion (Actual): November 27, 2019

Study Registration Dates

• First Submitted: September 19, 2016
• First Submitted That Met QC Criteria: September 30, 2016
• First Posted (Estimate): October 3, 2016

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 8, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: wound reduction wound healing, venous ulcers
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer; Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: CHEXU03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No