Trial Outcomes & Findings for Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)" (NCT NCT02237118)
NCT ID: NCT02237118
Last Updated: 2017-04-10
Results Overview
To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul®, during the first dressing removal. Pain measured by VAS Score ≥ 30 mm on the 100 mm VAS scale are reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
123 participants
Primary outcome timeframe
21 days
Results posted on
2017-04-10
Participant Flow
Participant milestones
| Measure |
Mepitel One
Pain on dressing removal, by VAS
Mepitel One
|
UrgoTul
Pain on removal by VAS
UrgoTul
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
63
|
|
Overall Study
COMPLETED
|
59
|
62
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Mepitel One
Pain on dressing removal, by VAS
Mepitel One
|
UrgoTul
Pain on removal by VAS
UrgoTul
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
consent withdrawn
|
1
|
0
|
Baseline Characteristics
Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)"
Baseline characteristics by cohort
| Measure |
UrgoTul
n=63 Participants
Pain on dressing removal, by VAS
Mepitel One
UrgoTul
|
Total
n=123 Participants
Total of all reporting groups
|
Mepitel One
n=60 Participants
Pain on dressing removal, by VAS
Mepitel One
UrgoTul
|
|---|---|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 23.0 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 22.2 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 21.2 • n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
31 participants
n=7 Participants
|
62 participants
n=5 Participants
|
31 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
32 participants
n=7 Participants
|
61 participants
n=5 Participants
|
29 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
63 participants
n=7 Participants
|
123 participants
n=5 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: intention to treat.Participants with None painfull dressing removal.
To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul®, during the first dressing removal. Pain measured by VAS Score ≥ 30 mm on the 100 mm VAS scale are reported.
Outcome measures
| Measure |
Mepitel One
n=59 Participants
Non-Painful dressing removal, measured by VAS
Mepitel One
UrgoTul
|
UrgoTul
n=62 Participants
Non-Painful dressing removal, measured by VAS
Mepitel One
UrgoTul
|
|---|---|---|
|
Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)
|
44 participants
|
39 participants
|
SECONDARY outcome
Timeframe: 21 daysComplete healing at day 21, will be measured using PictZar system.
Outcome measures
| Measure |
Mepitel One
n=60 Participants
Non-Painful dressing removal, measured by VAS
Mepitel One
UrgoTul
|
UrgoTul
n=63 Participants
Non-Painful dressing removal, measured by VAS
Mepitel One
UrgoTul
|
|---|---|---|
|
Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System.
|
0.89 percentage of wound size reduction
Standard Deviation 1.97
|
0.52 percentage of wound size reduction
Standard Deviation 1.09
|
SECONDARY outcome
Timeframe: 21 daysPopulation: Missing value for some patients
wound size estimation, assesstemnt of the wound,
Outcome measures
| Measure |
Mepitel One
n=60 Participants
Non-Painful dressing removal, measured by VAS
Mepitel One
UrgoTul
|
UrgoTul
n=63 Participants
Non-Painful dressing removal, measured by VAS
Mepitel One
UrgoTul
|
|---|---|---|
|
Condition of the Wound, Will be Assesst by the Investigator.
Bleeding · None
|
41 Participants
|
38 Participants
|
|
Condition of the Wound, Will be Assesst by the Investigator.
Bleeding · Mild
|
16 Participants
|
18 Participants
|
|
Condition of the Wound, Will be Assesst by the Investigator.
Bleeding · Moderate
|
2 Participants
|
2 Participants
|
|
Condition of the Wound, Will be Assesst by the Investigator.
Maceration · None
|
50 Participants
|
42 Participants
|
|
Condition of the Wound, Will be Assesst by the Investigator.
Maceration · Mild
|
5 Participants
|
14 Participants
|
|
Condition of the Wound, Will be Assesst by the Investigator.
Maceration · Moderate
|
4 Participants
|
2 Participants
|
|
Condition of the Wound, Will be Assesst by the Investigator.
Granulation tissue in growth in the dressing holes · None
|
37 Participants
|
39 Participants
|
|
Condition of the Wound, Will be Assesst by the Investigator.
Granulation tissue in growth in the dressing holes · Mild
|
12 Participants
|
13 Participants
|
|
Condition of the Wound, Will be Assesst by the Investigator.
Granulation tissue in growth in the dressing holes · Moderate
|
9 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 21 daysAdverse Event, Adverse Device Event
Outcome measures
| Measure |
Mepitel One
n=60 Participants
Non-Painful dressing removal, measured by VAS
Mepitel One
UrgoTul
|
UrgoTul
n=63 Participants
Non-Painful dressing removal, measured by VAS
Mepitel One
UrgoTul
|
|---|---|---|
|
Safety
Subject with Adverse Event
|
6 Participants
|
7 Participants
|
|
Safety
Subject with Adverse Device Effect
|
1 Participants
|
0 Participants
|
|
Safety
Subject with non AE
|
53 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: 21 daysassessment of the surrounding skin.
Outcome measures
| Measure |
Mepitel One
n=60 Participants
Non-Painful dressing removal, measured by VAS
Mepitel One
UrgoTul
|
UrgoTul
n=63 Participants
Non-Painful dressing removal, measured by VAS
Mepitel One
UrgoTul
|
|---|---|---|
|
Assessment of the Surrounding Skin.
Inflammatory signs
|
4 percentage of patients
|
7 percentage of patients
|
|
Assessment of the Surrounding Skin.
Irritation
|
2 percentage of patients
|
3 percentage of patients
|
|
Assessment of the Surrounding Skin.
Allergic rash
|
0 percentage of patients
|
1 percentage of patients
|
|
Assessment of the Surrounding Skin.
Blistering
|
1 percentage of patients
|
1 percentage of patients
|
|
Assessment of the Surrounding Skin.
Skin stripping
|
0 percentage of patients
|
1 percentage of patients
|
|
Assessment of the Surrounding Skin.
Maceration
|
1 percentage of patients
|
0 percentage of patients
|
|
Assessment of the Surrounding Skin.
Dry
|
1 percentage of patients
|
2 percentage of patients
|
|
Assessment of the Surrounding Skin.
Trauma to wound edges
|
1 percentage of patients
|
4 percentage of patients
|
|
Assessment of the Surrounding Skin.
Product degradation on the skin
|
0 percentage of patients
|
1 percentage of patients
|
|
Assessment of the Surrounding Skin.
Hematoma
|
5 percentage of patients
|
1 percentage of patients
|
|
Assessment of the Surrounding Skin.
other
|
1 percentage of patients
|
2 percentage of patients
|
Adverse Events
Mepitel One
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
UrgoTul
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mepitel One
n=60 participants at risk
Pain on dressing removal, by VAS
Mepitel One
UrgoTul
|
UrgoTul
n=63 participants at risk
Pain on removal by VAS
Mepitel One
UrgoTul
|
|---|---|---|
|
Endocrine disorders
Necrosis of left heel, diabetes
|
0.00%
0/60
|
1.6%
1/63 • Number of events 1
|
|
Cardiac disorders
pulmonary rhythm disorder
|
0.00%
0/60
|
1.6%
1/63 • Number of events 1
|
|
Cardiac disorders
cardiac insufficiency
|
0.00%
0/60
|
3.2%
2/63 • Number of events 2
|
|
Gastrointestinal disorders
Gastro intestinal bleeding
|
1.7%
1/60 • Number of events 1
|
0.00%
0/63
|
Other adverse events
| Measure |
Mepitel One
n=60 participants at risk
Pain on dressing removal, by VAS
Mepitel One
UrgoTul
|
UrgoTul
n=63 participants at risk
Pain on removal by VAS
Mepitel One
UrgoTul
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
cutaneous eruption
|
1.7%
1/60 • Number of events 1
|
0.00%
0/63
|
|
Gastrointestinal disorders
GASTROINTESTINAL BLEEDING
|
1.7%
1/60 • Number of events 1
|
0.00%
0/63
|
|
Skin and subcutaneous tissue disorders
ALLERGY
|
1.7%
1/60 • Number of events 1
|
0.00%
0/63
|
|
Skin and subcutaneous tissue disorders
acute elbow cellulite
|
1.7%
1/60 • Number of events 1
|
0.00%
0/63
|
|
Skin and subcutaneous tissue disorders
another wound surinfection with stapylococcus epidermidis
|
1.7%
1/60 • Number of events 1
|
0.00%
0/63
|
|
Musculoskeletal and connective tissue disorders
ANKLE SPRAIN
|
1.7%
1/60 • Number of events 1
|
0.00%
0/63
|
|
Skin and subcutaneous tissue disorders
ERYSIPELE
|
0.00%
0/60
|
1.6%
1/63 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
NECROSE necrosis on the left heel
|
0.00%
0/60
|
1.6%
1/63 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
RIGHT BASAL PULMONARY
|
0.00%
0/60
|
1.6%
1/63 • Number of events 1
|
|
Cardiac disorders
Hospitalization for cardiac insufficiency
|
0.00%
0/60
|
1.6%
1/63 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
acute bronchitis
|
0.00%
0/60
|
1.6%
1/63 • Number of events 1
|
|
Cardiac disorders
cardiorespiratory failure
|
0.00%
0/60
|
1.6%
1/63 • Number of events 1
|
|
General disorders
fall
|
0.00%
0/60
|
1.6%
1/63 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place