Trial Outcomes & Findings for Clinical Investigation of Two Different Wound Dressings (NCT NCT02904200)
NCT ID: NCT02904200
Last Updated: 2021-04-01
Results Overview
The primary objective of this investigation is to evaluate changes on Peri-Wound skin from baseline to termination when using two different wound dressings. The primary endpoint could not be calculated as intended because the baseline score was not evaluable due to missing values for the one subject that completed follow up. The primary outcome is therefore presented at 12 days. The total of the five scores provide a range from 0 to 15, with higher scores indicating a worse outcome. The primary endpoint was assessed through the change in the sum of Peri-Wound Skin outcome scores (0-15) collected at each visit (Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)) from baseline to termination. The sum of scores will be obtained from five separate data scores, Redness/Irritation, Flaky, Maceration, Blistering, Skin tears, which will be scored separately with a value between 0 and 3 (None=0, Mild=1, Moderate=2, Severe=3).
TERMINATED
NA
2 participants
Visit 4 last visit (day 12)
2021-04-01
Participant Flow
Participant milestones
| Measure |
Avance® Film With Safetac®
Sterile soft silicon adhesive dressing
Silicon adhesive dressing: Sterile soft silicon adhesive dressing
|
Avance® Transparent Film
Sterile acrylic adhesive dressing
Acrylic adhesive dressing: Sterile acrylic adhesive dressing
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Avance® Film With Safetac®
Sterile soft silicon adhesive dressing
Silicon adhesive dressing: Sterile soft silicon adhesive dressing
|
Avance® Transparent Film
Sterile acrylic adhesive dressing
Acrylic adhesive dressing: Sterile acrylic adhesive dressing
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Avance® Film With Safetac®
n=2 Participants
Sterile soft silicon adhesive dressing
Silicon adhesive dressing: Sterile soft silicon adhesive dressing
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=2 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
|
Region of Enrollment
Sweden
|
2 participants
n=2 Participants
|
|
Baseline Pain
|
1.5 score on a scale
STANDARD_DEVIATION 1.5 • n=2 Participants
|
PRIMARY outcome
Timeframe: Visit 4 last visit (day 12)Population: No statistical evaluation was performed because only 2 subjects were included into the study and 1 completed follow up (other subject withdrew consent). Due to missing values for the one subject that completed follow up, the primary outcome is presented at 12 days.
The primary objective of this investigation is to evaluate changes on Peri-Wound skin from baseline to termination when using two different wound dressings. The primary endpoint could not be calculated as intended because the baseline score was not evaluable due to missing values for the one subject that completed follow up. The primary outcome is therefore presented at 12 days. The total of the five scores provide a range from 0 to 15, with higher scores indicating a worse outcome. The primary endpoint was assessed through the change in the sum of Peri-Wound Skin outcome scores (0-15) collected at each visit (Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)) from baseline to termination. The sum of scores will be obtained from five separate data scores, Redness/Irritation, Flaky, Maceration, Blistering, Skin tears, which will be scored separately with a value between 0 and 3 (None=0, Mild=1, Moderate=2, Severe=3).
Outcome measures
| Measure |
Avance® Film With Safetac®
n=1 Participants
Sterile soft silicon adhesive dressing
Silicon adhesive dressing: Sterile soft silicon adhesive dressing
|
|---|---|
|
Changes on Peri-Wound Skin
|
3 score on a scale
|
SECONDARY outcome
Timeframe: 0-12 days. Visit 1 (baseline), Visit 2 (day 4), Visit 3 (day 7), Visit 4 last visit (day 12)Population: No statistical evaluation was performed because only 2 subjects were included into the study and 1 completed follow up (other subject withdrew consent). All data is presented for the one subject throughout their follow up of 4 visits.
Pain level before, during and after dressing removal. A visual analog scale (VAS) was used by the subjects to assess pain, with a range from 0 to 100, where 100 indicates the worst possible pain.
Outcome measures
| Measure |
Avance® Film With Safetac®
n=1 Participants
Sterile soft silicon adhesive dressing
Silicon adhesive dressing: Sterile soft silicon adhesive dressing
|
|---|---|
|
VAS Scale (0-100mm)
Visit 2: Pain DURING removal of the covering film
|
27 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 2: Pain AFTER removal of the covering film
|
2 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 1: Pain before application of NPWT
|
3 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 2: Pain BEFORE removal of the covering film
|
2 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 2: Pain BEFORE removal of the foam filler
|
5 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 2: Pain DURING removal of the foam filler
|
2 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 2: Pain AFTER removal of the foam filler
|
2 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 3: Pain BEFORE removal of the covering film
|
19 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 3: Pain DURING removal of the covering film
|
12 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 3: Pain AFTER removal of the covering film
|
10 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 3: Pain BEFORE removal of the foam filler
|
2 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 3: Pain DURING removal of the foam filler
|
5 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 3: Pain AFTER removal of the foam filler
|
5 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 4: Pain BEFORE removal of the covering film
|
4 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 4: Pain DURING removal of the covering film
|
17 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 4: Pain AFTER removal of the covering film
|
17 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 4: Pain BEFORE removal of the foam filler
|
4 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 4: Pain DURING removal of the foam filler
|
6 score on a scale (0-100)
|
|
VAS Scale (0-100mm)
Visit 4: Pain AFTER removal of the foam filler
|
9 score on a scale (0-100)
|
Adverse Events
Avance® Film With Safetac®
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Avance® Film With Safetac®
n=2 participants at risk
Sterile soft silicon adhesive dressing
Silicon adhesive dressing: Sterile soft silicon adhesive dressing
|
|---|---|
|
Skin and subcutaneous tissue disorders
Blisters
|
50.0%
1/2 • Number of events 1 • First Subject In (FSI): 17 Oct 2016 Last Subject Out (LSO): 18 Apr 2017 The subject was followed for 18 days for AE/SAE.
|
Additional Information
Global Clinical Research Director
Mölnlycke Health Care
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place