Trial Outcomes & Findings for A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers (NCT NCT02167815)
NCT ID: NCT02167815
Last Updated: 2016-10-26
Results Overview
Deteriorationin of skin condition , Mepilex XT and Standard care (%)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
16 weeks
Results posted on
2016-10-26
Participant Flow
Participant milestones
| Measure |
Standard Care
standard care ( such as alginate, hydrofiber or other treatment)
standard care
|
Intervention ( Mepilex XT)
Mepilex XT: Experimental arm
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
21
|
|
Overall Study
COMPLETED
|
9
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers
Baseline characteristics by cohort
| Measure |
Standard Care
n=9 Participants
standard care ( such as alginate, hydrofiber or other treatment)
standard care
|
Intervention ( Mepilex XT)
n=21 Participants
Mepilex XT: Experimental arm
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
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
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
9 participants
n=5 Participants
|
21 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: Intention to treat, change from baseline in condition of the peri-wound skin.
Deteriorationin of skin condition , Mepilex XT and Standard care (%)
Outcome measures
| Measure |
Intervention ( Mepilex XT)
n=21 Participants
Mepilex XT: Experimental arm
|
Standard Care
n=9 Participants
observation group, treating according to investigation sites standard care
|
|---|---|---|
|
Changes From Baseline in Condition of the Peri Wound Skin
Redness
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Changes From Baseline in Condition of the Peri Wound Skin
Rash
|
5.6 percentage of subjects
|
16.7 percentage of subjects
|
|
Changes From Baseline in Condition of the Peri Wound Skin
Maceration
|
11.1 percentage of subjects
|
16.7 percentage of subjects
|
|
Changes From Baseline in Condition of the Peri Wound Skin
Dermatitis
|
0 percentage of subjects
|
16.7 percentage of subjects
|
|
Changes From Baseline in Condition of the Peri Wound Skin
Blistering
|
0 percentage of subjects
|
0 percentage of subjects
|
|
Changes From Baseline in Condition of the Peri Wound Skin
skinstripping
|
5.6 percentage of subjects
|
0 percentage of subjects
|
|
Changes From Baseline in Condition of the Peri Wound Skin
Trauma to wound edges
|
5.6 percentage of subjects
|
0 percentage of subjects
|
|
Changes From Baseline in Condition of the Peri Wound Skin
Product degradation
|
16.7 percentage of subjects
|
16.7 percentage of subjects
|
SECONDARY outcome
Timeframe: 16 weeksPain at baseline visit, compared with pain at week 16. VAS scale, minimum pain = 0, maximum pain = 100.
Outcome measures
| Measure |
Intervention ( Mepilex XT)
n=21 Participants
Mepilex XT: Experimental arm
|
Standard Care
n=9 Participants
observation group, treating according to investigation sites standard care
|
|---|---|---|
|
Pain Scores on the Visual Analog Scale
Pain at baseline
|
17.6 units on a scale (VAS)
Standard Deviation 12.6
|
24.0 units on a scale (VAS)
Standard Deviation 22.2
|
|
Pain Scores on the Visual Analog Scale
Pain at week 16
|
5.8 units on a scale (VAS)
Standard Deviation 14.2
|
12.0 units on a scale (VAS)
Standard Deviation 21.7
|
SECONDARY outcome
Timeframe: 16 weeksInvestigator/Nurse and Subject evaluation of performance of the primary dressing ( n) Scale= Good , Very Good, Poor, Very Poor 1Ease of application, 2 Ease of removal, 3 Ability to retain exudate, 4 Adherence to healthy skin, 5 Confomability to be repositioned , 6 Overall satisfaction, 7 Dressing sticking to wound bed, 8 Presence of residues on the wound bed. 9 Presence of residues on the healthy skin. 10 Overall evaluation of change in periwound skin condition.
Outcome measures
| Measure |
Intervention ( Mepilex XT)
n=21 Participants
Mepilex XT: Experimental arm
|
Standard Care
n=9 Participants
observation group, treating according to investigation sites standard care
|
|---|---|---|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline overall satisfaction poor/very poor
|
0 participants
|
1 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last visit, ease of removal good/very good
|
18 participants
|
4 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last visit, retain exudate good/very good
|
17 participants
|
1 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last visit, retain of exudate poor
|
0 participants
|
4 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last visit, adherence to skin good/very good
|
17 participants
|
4 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last visit, overal satisfaction poor
|
0 participants
|
1 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last visit, sticking to the wound moderate/low
|
4 participants
|
5 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last visit, presence of residues wound none/low
|
18 participants
|
5 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last visit, presence of residues skin none
|
18 participants
|
4 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last visit, presence of residues skin moderate
|
0 participants
|
1 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline ability to be reposition good/very good
|
19 participants
|
8 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline ability to be reposition very poor/poor
|
1 participants
|
1 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline overall satisfaction good/very good
|
21 participants
|
8 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline sticking to woundbed moderate/high
|
0 participants
|
5 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline sticking to woundbed none/low
|
21 participants
|
4 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline pressens of residues wound moderate
|
0 participants
|
1 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline pressens of residues wound none/low
|
21 participants
|
7 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline pressens of residues skin none/low
|
21 participants
|
9 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last visit, ease of removal poor
|
0 participants
|
1 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last Visit, adherence to skin poor
|
1 participants
|
1 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last Visit, conformability good/very good
|
18 participants
|
4 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last visit, conformability poor
|
0 participants
|
1 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last Visit, ability to be reposition good/very goo
|
18 participants
|
4 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last Visit, ability to be reposition poor
|
0 participants
|
1 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last visit, overal satisfaction good/very good
|
18 participants
|
4 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last visit, sticking to the wound none
|
14 participants
|
0 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last visit, change in periwound condition improved
|
14 participants
|
5 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last visit, change in periwound skin unchanged
|
3 participants
|
1 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Last visit, change in periwound skin, deteriorated
|
1 participants
|
0 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline Ease of application good/very good
|
21 participants
|
9 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline Ease of removal good/very good
|
5 participants
|
6 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline Ease of removal poor/very poor
|
0 participants
|
3 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline Ability to retain exudate good/very good
|
21 participants
|
4 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline Ability to retain exudate poor
|
0 participants
|
5 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline Adherence to healthy skin good/very good
|
21 participants
|
5 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline Adherence to healthy skin poor/very poor
|
0 participants
|
4 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline conformability good/very good
|
21 participants
|
8 participants
|
|
Users Feedback After Handling or Use as a Measure of Performance.
Baseline conformability poor
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: the way to collect data differed to much betwen the sites, no analysis could be done.
Outcome measures
Outcome data not reported
Adverse Events
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention ( Mepilex XT)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Care
n=9 participants at risk
standard care ( such as alginate, hydrofiber or other treatment)
standard care
|
Intervention ( Mepilex XT)
n=21 participants at risk
Mepilex XT: Experimental arm
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Low pain in the skin under dressing
|
0.00%
0/9
|
9.5%
2/21 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
wound infection
|
0.00%
0/9
|
4.8%
1/21 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60