Trial Outcomes & Findings for Biatain Ag vs Biatain in the Treament of Leg Ulcers (NCT NCT00807664)

Last Updated: 2018-01-16

Results Overview

The measure of the ulcer was to measure its greatest lenght and width with these two axes being at right angles. An average of three measurements was to calculated the area of the ulcer by the equation: Area= Lenght \*Width \* pi \[3.142\] / 4 All planimetry records (using double-sided tracing paper) were centrally assessed and read by a blinded person not aware of which treatment that was used.

Recruitment status

COMPLETED

Study phase

Target enrollment

182 participants

Primary outcome timeframe

Day 0 to Day 42

Results posted on

2018-01-16

Participant Flow

Patients could be in-patients, out-patients attending hospital clinics specialising in phlebo-angiology, dermatology or vascular surgery, or patients being treated in a non-hospital setting

Participant milestones

Participant milestones
Measure	Biatain Ag Wound Dressing Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver	Biatain Wound Dressing Biatain dressing is a foam wound dressing
Overall Study STARTED	88	94
Overall Study COMPLETED	77	75
Overall Study NOT COMPLETED	11	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Biatain Ag vs Biatain in the Treament of Leg Ulcers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biatain Ag Wound Dressing n=88 Participants Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver	Biatain Wound Dressing n=94 Participants Biatain dressing is a foam wound dressing	Total n=182 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=99 Participants	25 Participants n=107 Participants	43 Participants n=206 Participants
Age, Categorical >=65 years	70 Participants n=99 Participants	69 Participants n=107 Participants	139 Participants n=206 Participants
Age, Continuous	75.1 years STANDARD_DEVIATION 11.8 • n=99 Participants	72.1 years STANDARD_DEVIATION 12.4 • n=107 Participants	73.5 years STANDARD_DEVIATION 12.2 • n=206 Participants
Sex: Female, Male Female	54 Participants n=99 Participants	44 Participants n=107 Participants	98 Participants n=206 Participants
Sex: Female, Male Male	34 Participants n=99 Participants	50 Participants n=107 Participants	84 Participants n=206 Participants
Region of Enrollment France	38 Participants n=99 Participants	38 Participants n=107 Participants	76 Participants n=206 Participants
Region of Enrollment Germany	25 Participants n=99 Participants	27 Participants n=107 Participants	52 Participants n=206 Participants
Region of Enrollment Belgium	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Region of Enrollment Denmark	19 Participants n=99 Participants	24 Participants n=107 Participants	43 Participants n=206 Participants
Region of Enrollment United Kingdom	3 Participants n=99 Participants	4 Participants n=107 Participants	7 Participants n=206 Participants

PRIMARY outcome

Timeframe: Day 0 to Day 42

Population: A total of 182 subjects were randomised in the study (safety analysis set), however one patient was in systemic antibiotic treatment and was erroneously enrolled, hence the ITT analysis set comprised 181 subjects.

Outcome measures

Outcome measures
Measure	Biatain Ag Wound Dressing n=87 Participants Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver	Biatain Wound Dressing n=94 Participants Biatain dressing is a foam wound dressing
Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 6 Compared to the Ulcer Area at Baseline	-41.5 Percentage change Standard Deviation 38.8	-35.0 Percentage change Standard Deviation 44.9

SECONDARY outcome

Timeframe: Day 0 to Day 70

Population: ITT (ANCOVA) - LOCF was applied for subjects not having a value at visit 3 but a value at visit 2 for the ulcer area

Outcome measures

Outcome measures
Measure	Biatain Ag Wound Dressing n=87 Participants Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver	Biatain Wound Dressing n=94 Participants Biatain dressing is a foam wound dressing
Percentage Change of the Leg Ulcer Area Measured by Planimetry at Week 10 Compared to the Ulcer Area at Baseline	-59.7 Percentage change Interval -78.8 to -40.6	-46.1 Percentage change Interval -65.4 to -26.8

SECONDARY outcome

Timeframe: Day 0 to Day 70

Outcome measures

Outcome measures
Measure	Biatain Ag Wound Dressing n=87 Participants Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver	Biatain Wound Dressing n=94 Participants Biatain dressing is a foam wound dressing
Total Number of Adverse Events Mild, not related	3 Adverse Event	2 Adverse Event
Total Number of Adverse Events mild, possibly related	1 Adverse Event	0 Adverse Event
Total Number of Adverse Events Moderate, not related	11 Adverse Event	11 Adverse Event
Total Number of Adverse Events moderate, possibly related	2 Adverse Event	2 Adverse Event
Total Number of Adverse Events moderate, related	1 Adverse Event	0 Adverse Event
Total Number of Adverse Events severe, not related	2 Adverse Event	1 Adverse Event
Total Number of Adverse Events severe, possibly related	2 Adverse Event	0 Adverse Event
Total Number of Adverse Events severe, related	0 Adverse Event	2 Adverse Event
Total Number of Adverse Events not specified, not related	0 Adverse Event	1 Adverse Event

Adverse Events

Biatain Ag Wound Dressing

Serious events: 5 serious events

Other events: 4 other events

Deaths: 0 deaths

Biatain Wound Dressing

Serious events: 7 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Biatain Ag Wound Dressing n=88 participants at risk Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver	Biatain Wound Dressing n=94 participants at risk Biatain dressing is a foam wound dressing
Social circumstances Fall	0.00% 0/88	1.1% 1/94 • Number of events 1
Respiratory, thoracic and mediastinal disorders pulmonary embolism	0.00% 0/88	1.1% 1/94 • Number of events 1
Cardiac disorders cardiac decompression	0.00% 0/88	1.1% 1/94 • Number of events 1
Infections and infestations Recurrance opposite leg mlum perforans pedis infection	1.1% 1/88 • Number of events 1	0.00% 0/94
Infections and infestations pneumoccal pneumonia hypoxemiante	1.1% 1/88 • Number of events 1	0.00% 0/94
Vascular disorders Arteriopathie left lower limb	1.1% 1/88 • Number of events 1	0.00% 0/94
Respiratory, thoracic and mediastinal disorders acute pulmonary edema	0.00% 0/88	1.1% 1/94 • Number of events 1
Musculoskeletal and connective tissue disorders important pain on right leg	0.00% 0/88	1.1% 1/94 • Number of events 1
Investigations Artheriography planned	0.00% 0/88	1.1% 1/94 • Number of events 1
Social circumstances Alteration of general state	1.1% 1/88 • Number of events 1	0.00% 0/94
Cardiac disorders Attack of angina	1.1% 1/88 • Number of events 1	0.00% 0/94
Cardiac disorders Cardiac arrest	0.00% 0/88	1.1% 1/94 • Number of events 1

Other adverse events

Other adverse events
Measure	Biatain Ag Wound Dressing n=88 participants at risk Biatain Ag wound dressing, is a foam wound dressing including hydro-activated silver	Biatain Wound Dressing n=94 participants at risk Biatain dressing is a foam wound dressing
Skin and subcutaneous tissue disorders Maceration - eczema - redness - pain of wound and peri-wound skin	4.5% 4/88 • Number of events 4	2.1% 2/94 • Number of events 2

Additional Information

Dr Birte Petersen Jacobsen

Coloplast

Phone: 004549110000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place