Trial Outcomes & Findings for 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 NCT02921750)

Last Updated: 2020-11-02

Results Overview

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)

Recruitment status

COMPLETED

Study phase

Target enrollment

248 participants

Primary outcome timeframe

6 weeks

Results posted on

2020-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Exufiber Investigational Device: Exufiber® gelling fibre dressing as primary dressing to facilitate moist healing of venous leg ulcer.	Aquacel Comparator - Aquacel® Extra™ Hydrofiber® Dressing with Strengthening Fibre as primary dressing to facilitate moist healing of venous leg ulcer.
Overall Study STARTED	124	124
Overall Study Intention to Treat (ITT)	122	123
Overall Study Per Protocol (PP)	100	107
Overall Study Completed 6 Weeks Follow-up (PP)	97	104
Overall Study Subgroup Followed for 24 Weeks (ITT)	35	40
Overall Study Subgroup Followed for 24 Weeks (PP)	19	36
Overall Study COMPLETED	115	113
Overall Study NOT COMPLETED	9	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Exufiber Investigational Device: Exufiber® gelling fibre dressing as primary dressing to facilitate moist healing of venous leg ulcer.	Aquacel Comparator - Aquacel® Extra™ Hydrofiber® Dressing with Strengthening Fibre as primary dressing to facilitate moist healing of venous leg ulcer.
Overall Study Adverse Event	1	2
Overall Study Withdrawal by Subject	1	1
Overall Study Lost to Follow-up	3	3
Overall Study Wound healed	3	3
Overall Study Serious Adverse Event	1	2

Baseline Characteristics

Intention to treat population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exufiber n=122 Participants Investigational device: Exufiber Gelling fibre dressing	Aquacel n=123 Participants Comparator: Aquacel® Extra™ Hydrofiber® Dressing with Strengthening Fibre	Total n=245 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=122 Participants	0 Participants n=123 Participants	0 Participants n=245 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=122 Participants	47 Participants n=123 Participants	88 Participants n=245 Participants
Age, Categorical >=65 years	81 Participants n=122 Participants	76 Participants n=123 Participants	157 Participants n=245 Participants
Age, Continuous	70.0 years STANDARD_DEVIATION 12.3 • n=122 Participants	69.0 years STANDARD_DEVIATION 15.0 • n=123 Participants	69.5 years STANDARD_DEVIATION 13.7 • n=245 Participants
Sex: Female, Male Female	62 Participants n=122 Participants	69 Participants n=123 Participants	131 Participants n=245 Participants
Sex: Female, Male Male	60 Participants n=122 Participants	54 Participants n=123 Participants	114 Participants n=245 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=122 Participants	0 Participants n=123 Participants	0 Participants n=245 Participants
Race (NIH/OMB) Asian	0 Participants n=122 Participants	0 Participants n=123 Participants	0 Participants n=245 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=122 Participants	0 Participants n=123 Participants	0 Participants n=245 Participants
Race (NIH/OMB) Black or African American	0 Participants n=122 Participants	0 Participants n=123 Participants	0 Participants n=245 Participants
Race (NIH/OMB) White	89 Participants n=122 Participants	93 Participants n=123 Participants	182 Participants n=245 Participants
Race (NIH/OMB) More than one race	0 Participants n=122 Participants	0 Participants n=123 Participants	0 Participants n=245 Participants
Race (NIH/OMB) Unknown or Not Reported	33 Participants n=122 Participants	30 Participants n=123 Participants	63 Participants n=245 Participants
Region of Enrollment Czechia	17 participants n=17 Participants • Intention to treat population	21 participants n=21 Participants • Intention to treat population	38 participants n=38 Participants • Intention to treat population
Region of Enrollment Denmark	3 participants n=3 Participants • Intention to treat population	6 participants n=6 Participants • Intention to treat population	9 participants n=9 Participants • Intention to treat population
Region of Enrollment Poland	48 participants n=48 Participants • Intention to treat population	51 participants n=51 Participants • Intention to treat population	99 participants n=99 Participants • Intention to treat population
Region of Enrollment France	21 participants n=21 Participants • Intention to treat population	25 participants n=25 Participants • Intention to treat population	46 participants n=46 Participants • Intention to treat population
Region of Enrollment Germany	18 participants n=18 Participants • Intention to treat population	15 participants n=15 Participants • Intention to treat population	33 participants n=33 Participants • Intention to treat population
Region of Enrollment Sweden	15 participants n=15 Participants • Intention to treat population	5 participants n=5 Participants • Intention to treat population	20 participants n=20 Participants • Intention to treat population

PRIMARY outcome

Timeframe: 6 weeks

Population: PP analysis set, tested for non-inferiority

Outcome measures

Outcome measures
Measure	Exufiber n=100 Participants Investigational device, Exufiber Gelling Fibre Dressing	Aquacel n=107 Participants Comparator, Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre
Wound Area Change (%)	-49.7 relative wound area change in percentage Interval -100.0 to 191.2	-42.4 relative wound area change in percentage Interval -100.0 to 1538.4

SECONDARY outcome

Timeframe: 6 weeks

Population: ITT analysis set

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)

Outcome measures

Outcome measures
Measure	Exufiber n=122 Participants Investigational device, Exufiber Gelling Fibre Dressing	Aquacel n=123 Participants Comparator, Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre
Wound Area Change (cm2)	-4.64 relative wound area change in cm2 Standard Deviation 7.73	-3.48 relative wound area change in cm2 Standard Deviation 7.59

SECONDARY outcome

Timeframe: 6 weeks

Population: ITT analysis set.

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.

Outcome measures

Outcome measures
Measure	Exufiber n=122 Participants Investigational device, Exufiber Gelling Fibre Dressing	Aquacel n=123 Participants Comparator, Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre
Linear Advance of Wound Margin	0.008 cm/day Standard Deviation 0.010	0.007 cm/day Standard Deviation 0.010

SECONDARY outcome

Timeframe: 6 weeks

Population: ITT analysis set

Pain was reported by patients and measured by Visual Analogue Scale (VAS) 0-100mm, where 0=is no pain, 100=is worst pain ever.

Outcome measures

Outcome measures
Measure	Exufiber n=122 Participants Investigational device, Exufiber Gelling Fibre Dressing	Aquacel n=123 Participants Comparator, Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre
Pain During Debridement	25.8 mm Standard Deviation 27.2	26.9 mm Standard Deviation 29.0

SECONDARY outcome

Timeframe: 6 weeks

Population: ITT analysis set

Pain was reported by patients and measured by Visual Analogue Scale (VAS) 0-100mm, where 0=is no pain, 100=is worst pain ever.

Outcome measures

Outcome measures
Measure	Exufiber n=122 Participants Investigational device, Exufiber Gelling Fibre Dressing	Aquacel n=123 Participants Comparator, Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre
Pain at Dressing Removal	16.3 mm Standard Deviation 22.0	16.9 mm Standard Deviation 22.8

SECONDARY outcome

Timeframe: 6 weeks

Population: ITT analysis set.

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.

Outcome measures

Outcome measures
Measure	Exufiber n=122 Participants Investigational device, Exufiber Gelling Fibre Dressing	Aquacel n=123 Participants Comparator, Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre
Percentage of Clinicians of Opinion 'Very Good' for Dressing Features Ease of application of dressing	58.4 Percentage reported 'very good'	57.5 Percentage reported 'very good'
Percentage of Clinicians of Opinion 'Very Good' for Dressing Features Overall experience of dressing	46 Percentage reported 'very good'	32.5 Percentage reported 'very good'
Percentage of Clinicians of Opinion 'Very Good' for Dressing Features Ease of removal of dressing	48.7 Percentage reported 'very good'	35.9 Percentage reported 'very good'
Percentage of Clinicians of Opinion 'Very Good' for Dressing Features Flexibility of dressing	48.0 Percentage reported 'very good'	40.8 Percentage reported 'very good'
Percentage of Clinicians of Opinion 'Very Good' for Dressing Features Conformability to the wound	39.9 Percentage reported 'very good'	36.2 Percentage reported 'very good'
Percentage of Clinicians of Opinion 'Very Good' for Dressing Features Ability to Absorb Exudates	49.2 Percentage reported 'very good'	32.3 Percentage reported 'very good'
Percentage of Clinicians of Opinion 'Very Good' for Dressing Features Ability to Retain Exudate	47.8 Percentage reported 'very good'	31.7 Percentage reported 'very good'
Percentage of Clinicians of Opinion 'Very Good' for Dressing Features Ability to Absorb Blood	38.4 Percentage reported 'very good'	32.5 Percentage reported 'very good'
Percentage of Clinicians of Opinion 'Very Good' for Dressing Features Ability to Keep Blood and Slough	36.3 Percentage reported 'very good'	28.1 Percentage reported 'very good'

SECONDARY outcome

Timeframe: 6 weeks

Population: ITT analysis set.

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.

Outcome measures

Outcome measures
Measure	Exufiber n=122 Participants Investigational device, Exufiber Gelling Fibre Dressing	Aquacel n=123 Participants Comparator, Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre
Percentage of Clinicians of Opinion 'Does Not Adhere' Related to Dressing Features Non-adherence to peri-wound skin at removal	72.0 Percentage reported 'does not adhere'	52.1 Percentage reported 'does not adhere'
Percentage of Clinicians of Opinion 'Does Not Adhere' Related to Dressing Features Non-adherence to wound bed at removal	44.2 Percentage reported 'does not adhere'	31.1 Percentage reported 'does not adhere'

OTHER_PRE_SPECIFIED outcome

Timeframe: from baseline to 24 weeks

Population: Subgroup followed until healing or up to 24 weeks.

Wound healing assessments were based on blind independent clinical review of photos.

Outcome measures

Outcome measures
Measure	Exufiber n=35 Participants Investigational device, Exufiber Gelling Fibre Dressing	Aquacel n=40 Participants Comparator, Aquacel® Extra™ Hydrofiber® dressing with strengthening fibre
Percentage of Participants With Healed Wounds	40.0 Percentage of participants	47.5 Percentage of participants

Adverse Events

Exufiber

Serious events: 5 serious events

Other events: 18 other events

Deaths: 1 deaths

Aquacel

Serious events: 8 serious events

Other events: 19 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Exufiber n=124 participants at risk Investigational device, Exufiber Gelling fibre dressing	Aquacel n=124 participants at risk Comparator, Aquacel® Extra™ Hydrofiber® Dressing with Strengthening Fibre
Injury, poisoning and procedural complications Fracture and hospitalisation	0.81% 1/124 • Number of events 1 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h	0.00% 0/124 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h
Injury, poisoning and procedural complications Hip fracture	0.81% 1/124 • Number of events 1 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h	0.00% 0/124 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h
Cardiac disorders Heart failure	0.81% 1/124 • Number of events 1 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h	0.00% 0/124 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h
Skin and subcutaneous tissue disorders Erysipelas right leg	0.81% 1/124 • Number of events 1 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h	0.00% 0/124 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h
Gastrointestinal disorders Gastric hemorrhage with hospitalization	0.00% 0/124 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h	0.81% 1/124 • Number of events 1 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h
Renal and urinary disorders Death	0.81% 1/124 • Number of events 1 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h	0.81% 1/124 • Number of events 1 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h
Skin and subcutaneous tissue disorders Pain	0.00% 0/124 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h	0.81% 1/124 • Number of events 1 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h
Renal and urinary disorders Infection exacerbated COPD	0.00% 0/124 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h	0.81% 1/124 • Number of events 1 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h
Skin and subcutaneous tissue disorders Erysipelas PDK, hospitalize	0.00% 0/124 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h	0.81% 1/124 • Number of events 1 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h
Psychiatric disorders Intensification of depression	0.00% 0/124 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h	0.81% 1/124 • Number of events 1 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h
General disorders Circulatory insufficiency with dehydration and dizziness	0.00% 0/124 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h	0.81% 1/124 • Number of events 1 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h
Cardiac disorders Congestive heart failure	0.00% 0/124 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h	0.81% 1/124 • Number of events 1 • Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h

Other adverse events

Additional Information

Maria Åberg Håkansson

Mölnlycke Health Care

Phone: +46 31722 3000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place