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
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
248
Gelling fibre dressing
Hydrofiber® Dressing with Strengthening Fibre
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)
Time frame: 6 weeks
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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Soběslav, Czechia
Salvatella LTD
Třinec, Czechia
Bispebjerg Hospital
Copenhagen, Copenhagen NV, Denmark
Hôpital Michallon
Grenoble, France
Groupe Hospitalier
La Rochelle, France
...and 23 more locations
Time frame: 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.
Time frame: 6 weeks