Pain
Conditions
Keywords
Acute, wound, management, measured, Visual analoge scale
Brief summary
To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound management.
Interventions
DEVICEMepitel One
DEVICEUrgoTul
Sponsors
Molnlycke Health Care AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Acute wound: traumatic wound (dermabrasion, skin tears, other), benign burn requiring the use of dressings 2. Acute wound size between 3 cm² and 240 cm2 (wound could be covered by 2 investigational products maximum) 3. Wound whose duration is ≤ 3 days 4. Both gender with an age ≥ 18 years 5. Subject able to understand and voluntarily sign the informed consent 6. Subject able to follow the protocol 7. Subject insured to the French social security system
Exclusion criteria
1. Surgical wound 2. Infected, moderately to strongly exudative and haemorrhagic wound 3. Diagnosed underlying disease (e.g. diabetic neuropathy, stroke, …) which, as judged by the investigator, could interfere with the pain assessment 4. Known allergy/hypersensitivity to any of the components of the investigational products 5. Participation in other clinical investigation within one month prior to start of investigation 6. Pregnant or breast-feeding women 7. Person protected by a legal regime (tutorship or guardianship)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS) | 21 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System. | 21 days | Complete healing at day 21, will be measured using PictZar system. |
| Condition of the Wound, Will be Assesst by the Investigator. | 21 days | wound size estimation, assesstemnt of the wound, |
| Safety | 21 days | Adverse Event, Adverse Device Event |
| Assessment of the Surrounding Skin. | 21 days | assessment of the surrounding skin. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mepitel One Pain on dressing removal, by VAS
Mepitel One
UrgoTul | 60 |
| UrgoTul Pain on dressing removal, by VAS
Mepitel One
UrgoTul | 63 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | consent withdrawn | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Mepitel One | UrgoTul | Total |
|---|---|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 21.2 | 59.8 years STANDARD_DEVIATION 23 | 62.3 years STANDARD_DEVIATION 22.2 |
| Age, Customized >=65 years | 29 participants | 32 participants | 61 participants |
| Age, Customized Between 18 and 65 years | 31 participants | 31 participants | 62 participants |
| Region of Enrollment France | 60 participants | 63 participants | 123 participants |
| Sex: Female, Male Female | 31 Participants | 28 Participants | 59 Participants |
| Sex: Female, Male Male | 29 Participants | 35 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 60 | 7 / 63 |
| serious Total, serious adverse events | 1 / 60 | 4 / 63 |
Outcome results
Primary
Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)
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.
Time frame: 21 days
Population: intention to treat.Participants with None painfull dressing removal.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mepitel One | Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS) | 44 participants |
| UrgoTul | Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS) | 39 participants |
Secondary
Assessment of the Surrounding Skin.
assessment of the surrounding skin.
Time frame: 21 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mepitel One | Assessment of the Surrounding Skin. | Blistering | 1 percentage of patients |
| Mepitel One | Assessment of the Surrounding Skin. | Dry | 1 percentage of patients |
| Mepitel One | Assessment of the Surrounding Skin. | Allergic rash | 0 percentage of patients |
| Mepitel One | Assessment of the Surrounding Skin. | Trauma to wound edges | 1 percentage of patients |
| Mepitel One | Assessment of the Surrounding Skin. | Skin stripping | 0 percentage of patients |
| Mepitel One | Assessment of the Surrounding Skin. | Product degradation on the skin | 0 percentage of patients |
| Mepitel One | Assessment of the Surrounding Skin. | Irritation | 2 percentage of patients |
| Mepitel One | Assessment of the Surrounding Skin. | Hematoma | 5 percentage of patients |
| Mepitel One | Assessment of the Surrounding Skin. | Maceration | 1 percentage of patients |
| Mepitel One | Assessment of the Surrounding Skin. | other | 1 percentage of patients |
| Mepitel One | Assessment of the Surrounding Skin. | Inflammatory signs | 4 percentage of patients |
| UrgoTul | Assessment of the Surrounding Skin. | other | 2 percentage of patients |
| UrgoTul | Assessment of the Surrounding Skin. | Inflammatory signs | 7 percentage of patients |
| UrgoTul | Assessment of the Surrounding Skin. | Irritation | 3 percentage of patients |
| UrgoTul | Assessment of the Surrounding Skin. | Allergic rash | 1 percentage of patients |
| UrgoTul | Assessment of the Surrounding Skin. | Blistering | 1 percentage of patients |
| UrgoTul | Assessment of the Surrounding Skin. | Skin stripping | 1 percentage of patients |
| UrgoTul | Assessment of the Surrounding Skin. | Maceration | 0 percentage of patients |
| UrgoTul | Assessment of the Surrounding Skin. | Dry | 2 percentage of patients |
| UrgoTul | Assessment of the Surrounding Skin. | Trauma to wound edges | 4 percentage of patients |
| UrgoTul | Assessment of the Surrounding Skin. | Product degradation on the skin | 1 percentage of patients |
| UrgoTul | Assessment of the Surrounding Skin. | Hematoma | 1 percentage of patients |
Secondary
Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System.
Complete healing at day 21, will be measured using PictZar system.
Time frame: 21 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mepitel One | 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 |
| UrgoTul | Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System. | 0.52 percentage of wound size reduction | Standard Deviation 1.09 |
Secondary
Condition of the Wound, Will be Assesst by the Investigator.
wound size estimation, assesstemnt of the wound,
Time frame: 21 days
Population: Missing value for some patients
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Mepitel One | Condition of the Wound, Will be Assesst by the Investigator. | Granulation tissue in growth in the dressing holes | None | 37 Participants |
| Mepitel One | Condition of the Wound, Will be Assesst by the Investigator. | Granulation tissue in growth in the dressing holes | Mild | 12 Participants |
| Mepitel One | Condition of the Wound, Will be Assesst by the Investigator. | Granulation tissue in growth in the dressing holes | Moderate | 9 Participants |
| Mepitel One | Condition of the Wound, Will be Assesst by the Investigator. | Bleeding | None | 41 Participants |
| Mepitel One | Condition of the Wound, Will be Assesst by the Investigator. | Bleeding | Mild | 16 Participants |
| Mepitel One | Condition of the Wound, Will be Assesst by the Investigator. | Bleeding | Moderate | 2 Participants |
| Mepitel One | Condition of the Wound, Will be Assesst by the Investigator. | Maceration | None | 50 Participants |
| Mepitel One | Condition of the Wound, Will be Assesst by the Investigator. | Maceration | Mild | 5 Participants |
| Mepitel One | Condition of the Wound, Will be Assesst by the Investigator. | Maceration | Moderate | 4 Participants |
| UrgoTul | Condition of the Wound, Will be Assesst by the Investigator. | Maceration | Mild | 14 Participants |
| UrgoTul | Condition of the Wound, Will be Assesst by the Investigator. | Bleeding | Moderate | 2 Participants |
| UrgoTul | Condition of the Wound, Will be Assesst by the Investigator. | Granulation tissue in growth in the dressing holes | Mild | 13 Participants |
| UrgoTul | Condition of the Wound, Will be Assesst by the Investigator. | Granulation tissue in growth in the dressing holes | None | 39 Participants |
| UrgoTul | Condition of the Wound, Will be Assesst by the Investigator. | Granulation tissue in growth in the dressing holes | Moderate | 5 Participants |
| UrgoTul | Condition of the Wound, Will be Assesst by the Investigator. | Maceration | None | 42 Participants |
| UrgoTul | Condition of the Wound, Will be Assesst by the Investigator. | Bleeding | None | 38 Participants |
| UrgoTul | Condition of the Wound, Will be Assesst by the Investigator. | Maceration | Moderate | 2 Participants |
| UrgoTul | Condition of the Wound, Will be Assesst by the Investigator. | Bleeding | Mild | 18 Participants |
Secondary
Safety
Adverse Event, Adverse Device Event
Time frame: 21 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mepitel One | Safety | Subject with Adverse Event | 6 Participants |
| Mepitel One | Safety | Subject with Adverse Device Effect | 1 Participants |
| Mepitel One | Safety | Subject with non AE | 53 Participants |
| UrgoTul | Safety | Subject with Adverse Event | 7 Participants |
| UrgoTul | Safety | Subject with Adverse Device Effect | 0 Participants |
| UrgoTul | Safety | Subject with non AE | 56 Participants |