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To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepitel One | Active Comparator | Pain on dressing removal, by VAS |
|
| UrgoTul | Active Comparator | Pain on removal by VAS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepitel One | Device |
| ||
| UrgoTul |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 days |
| Condition of the Wound, Will be Assesst by the Investigator. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Solanilla, Dr | Clinique Mutualiste du Medoc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Mutualiste du Medoc | Lespare | 33340 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mepitel One | Pain on dressing removal, by VAS Mepitel One |
| FG001 | UrgoTul | Pain on removal by VAS UrgoTul |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mepitel One | Pain on dressing removal, by VAS Mepitel One UrgoTul |
| BG001 | UrgoTul | Pain on dressing removal, by VAS Mepitel One UrgoTul |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | intention to treat.Participants with None painfull dressing removal. | Posted | Number | participants | 21 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mepitel One | Pain on dressing removal, by VAS Mepitel One UrgoTul |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Necrosis of left heel, diabetes | Endocrine disorders | Necrosis of left heel, diabetes, leading to hospitalisation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cutaneous eruption | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Anne Solanilla | Clinique Mutualiste du Medoc | +33 5 56 73 11 43 | annasolanilla@yahoo.fr |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
wound size estimation, assesstemnt of the wound,
| 21 days |
| Safety | Adverse Event, Adverse Device Event | 21 days |
| Assessment of the Surrounding Skin. | assessment of the surrounding skin. | 21 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage of wound size reduction | 21 days |
|
|
|
| Secondary | Condition of the Wound, Will be Assesst by the Investigator. | wound size estimation, assesstemnt of the wound, | Missing value for some patients | Posted | Count of Participants | Participants | 21 days |
|
|
|
| Secondary | Safety | Adverse Event, Adverse Device Event | Posted | Count of Participants | Participants | 21 days |
|
|
|
| Secondary | Assessment of the Surrounding Skin. | assessment of the surrounding skin. | Posted | Number | percentage of patients | 21 days |
|
|
|
| 1 |
| 60 |
| 6 |
| 60 |
| EG001 | UrgoTul | Pain on removal by VAS Mepitel One UrgoTul | 4 | 63 | 7 | 63 |
|
| pulmonary rhythm disorder | Cardiac disorders | pulmonary rhythm disorder, leading to hospitalisation |
|
| cardiac insufficiency | Cardiac disorders | cardiac insufficiency, both leading to hospitalisation |
|
| Gastro intestinal bleeding | Gastrointestinal disorders | gastro intestinal bleeding, life threatening |
|
| GASTROINTESTINAL BLEEDING | Gastrointestinal disorders | GASTROINTESTINAL BLEEDING |
|
| ALLERGY | Skin and subcutaneous tissue disorders | ALLERGY |
|
| acute elbow cellulite | Skin and subcutaneous tissue disorders | acute elbow cellulite |
|
| another wound surinfection with stapylococcus epidermidis | Skin and subcutaneous tissue disorders | another wond surinfection with stapylococcus epidermidis |
|
| ANKLE SPRAIN | Musculoskeletal and connective tissue disorders | ANKLE SPRAIN |
|
| ERYSIPELE | Skin and subcutaneous tissue disorders | ERYSIPELE |
|
| NECROSE necrosis on the left heel | Skin and subcutaneous tissue disorders | NECROSE necrosis on the left heel |
|
| RIGHT BASAL PULMONARY | Respiratory, thoracic and mediastinal disorders | RIGHT BASAL PULMONARY |
|
| Hospitalization for cardiac insufficiency | Cardiac disorders | Hospitalization for cardiac insufficiency |
|
| acute bronchitis | Respiratory, thoracic and mediastinal disorders | acute bronchitis |
|
| cardiorespiratory failure | Cardiac disorders | cardiorespiratory failure |
|
| fall | General disorders | fall |
|
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| Mild |
|
| Moderate |
|
| Maceration |
|
|
| Granulation tissue in growth in the dressing holes |
|
|
| Subject with non AE |
|
| Allergic rash |
|
| Blistering |
|
| Skin stripping |
|
| Maceration |
|
| Dry |
|
| Trauma to wound edges |
|
| Product degradation on the skin |
|
| Hematoma |
|
| other |
|