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

Venous Leg Ulcer Clinical Trial

— PD-497314  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921750
• Other study ID #: CHEXU03
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: November 27, 2019

Study information

• Verified date: October 2020
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: November 27, 2019
• Est. primary completion date: November 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• Exufiber Gelling Fibre Dressing
Gelling fibre dressing
• Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre
Hydrofiber® Dressing with Strengthening Fibre

Locations

Country	Name	City	State
Czechia	St. Ann University Hospital Dep of Dermatovenereology	Brno
Czechia	Hospital Jihlava	Jihlava
Czechia	Regional hospital Pardubice Dermatology Department	Pardubice
Czechia	Fakultní nemocnice Královské Vinohrady (FNKV)Department of General Surgery 3	Prague
Czechia	General University Hospital in Prague	Prague
Czechia	Diabetologie	Sobeslav
Czechia	Salvatella LTD	Trinec
Denmark	Bispebjerg Hospital	Copenhagen	Copenhagen NV
France	Hôpital Michallon	Grenoble
France	Groupe Hospitalier	La Rochelle
France	Hospital Géneral du Mans	Le Mans
France	Clinique du Parc Unité de Cicatrisation	Lyon
France	CHU Nantes	Nantes
France	Clinique Pasteur	Toulouse
Germany	Wundzentrum Augsburg	Augsburg
Germany	WundZentrum Dortmund	Dortmund
Germany	WundZentrum Düsseldorf	Düsseldorf
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Venenzentrum Freiburg	Freiburg
Germany	Paracelsus-Klinik am Silbersee	Hannover
Germany	University Hospital Schleswig-Holstein	Kiel
Germany	Johannes-Gutenberg-Universität Mainz	Mainz
Germany	WundZentrum München Nord	München
Germany	WundZentrum Ulm	Ulm
Poland	Uslugi Medyczne PRO-MED Sp. z o.o., ul.	Gliwice
Poland	Niepubliczny Zaklad Opieki Zdrowotnej "GAM-MED", ul.	Kielce
Poland	Niepubliczny Zaklad Opieki Zdrowotnej "Mikomed", ul.	Lódz
Poland	Medical Hair & Esthetic, ul.	Lublin
Sweden	Lund university Hospital,	Lund
Sweden	Avdelningen för kliniska prövningar, Universitetssjukhuset Örebro	Örebro
Sweden	Skellefteå Lasarett	Skellefteå
Sweden	Karolinska Trial Alliance, Prim	Stockholm
Sweden	Södersjukhuset (Sårcentrum)	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Countries where clinical trial is conducted

Czechia,  Denmark,  France,  Germany,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants With Healed Wounds	Wound healing assessments were based on blind independent clinical review of photos.	from baseline to 24 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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