Trial Outcomes & Findings for Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers (NCT NCT01036438)
NCT ID: NCT01036438
Last Updated: 2014-09-12
Results Overview
Efficacy will be defined as absolute wound size reduction.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
201 participants
Primary outcome timeframe
8 weeks
Results posted on
2014-09-12
Participant Flow
Participant milestones
| Measure |
Mepilex Product
Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
|
Mepilex Ag
Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
100
|
|
Overall Study
COMPLETED
|
91
|
90
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
Reasons for withdrawal
| Measure |
Mepilex Product
Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
|
Mepilex Ag
Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
8
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
No effect of study treatment
|
3
|
1
|
Baseline Characteristics
Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers
Baseline characteristics by cohort
| Measure |
Mepilex Product
n=101 Participants
Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
|
Mepilex Ag
n=100 Participants
Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
68.4 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
67.5 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
54 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
47 participants
n=5 Participants
|
47 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
28 participants
n=5 Participants
|
26 participants
n=7 Participants
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksEfficacy will be defined as absolute wound size reduction.
Outcome measures
| Measure |
Mepilex Product
n=101 Participants
Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
|
Mepilex Ag
n=100 Participants
Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
|
|---|---|---|
|
Efficacy Will be Defined as Absolute Wound Size Reduction.
|
-4.65 cm2
Standard Deviation 15.43
|
-5.09 cm2
Standard Deviation 14.23
|
SECONDARY outcome
Timeframe: 4 weeksChange in inflammatory signs
Outcome measures
Outcome data not reported
Adverse Events
Mepilex Product
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Mepilex Ag
Serious events: 4 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mepilex Product
n=101 participants at risk
Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
|
Mepilex Ag
n=100 participants at risk
Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Aggravation of ulcus
|
0.99%
1/101 • Number of events 1
|
0.00%
0/100
|
|
Skin and subcutaneous tissue disorders
Erysephilas needing hospitalisation
|
0.99%
1/101 • Number of events 1
|
0.00%
0/100
|
|
Musculoskeletal and connective tissue disorders
Pain on left arm /shoulder
|
0.00%
0/101
|
1.0%
1/100 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acute exacerbation of psoriasis vulgaris
|
0.00%
0/101
|
1.0%
1/100 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/101
|
1.0%
1/100 • Number of events 1
|
|
Cardiac disorders
Cardiac decompensation
|
0.00%
0/101
|
1.0%
1/100 • Number of events 1
|
Other adverse events
| Measure |
Mepilex Product
n=101 participants at risk
Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
|
Mepilex Ag
n=100 participants at risk
Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Adverse event related to the ulcer
|
18.8%
19/101
|
14.0%
14/100
|
|
Investigations
Other Adverse Event not related to the ulcer
|
10.9%
11/101
|
7.0%
7/100
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60