Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-02-26 @ 7:25 PM
Study NCT ID:
NCT02237118
Status:
COMPLETED
Last Update Posted:
2017-04-10
First Post:
2014-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)"
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'annasolanilla@yahoo.fr', 'phone': '+33 5 56 73 11 43', 'title': 'Dr Anne Solanilla', 'organization': 'Clinique Mutualiste du Medoc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Mepitel One', 'description': 'Pain on dressing removal, by VAS\n\nMepitel One\n\nUrgoTul', 'otherNumAtRisk': 60, 'otherNumAffected': 6, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'UrgoTul', 'description': 'Pain on removal by VAS\n\nMepitel One\n\nUrgoTul', 'otherNumAtRisk': 63, 'otherNumAffected': 7, 'seriousNumAtRisk': 63, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'cutaneous eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'GASTROINTESTINAL BLEEDING', 'notes': 'GASTROINTESTINAL BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'ALLERGY', 'notes': 'ALLERGY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'acute elbow cellulite', 'notes': 'acute elbow cellulite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'another wound surinfection with stapylococcus epidermidis', 'notes': 'another wond surinfection with stapylococcus epidermidis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'ANKLE SPRAIN', 'notes': 'ANKLE SPRAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'ERYSIPELE', 'notes': 'ERYSIPELE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'NECROSE necrosis on the left heel', 'notes': 'NECROSE necrosis on the left heel', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'RIGHT BASAL PULMONARY', 'notes': 'RIGHT BASAL PULMONARY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hospitalization for cardiac insufficiency', 'notes': 'Hospitalization for cardiac insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'acute bronchitis', 'notes': 'acute bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'cardiorespiratory failure', 'notes': 'cardiorespiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'fall', 'notes': 'fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}], 'seriousEvents': [{'term': 'Necrosis of left heel, diabetes', 'notes': 'Necrosis of left heel, diabetes, leading to hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders'}, {'term': 'pulmonary rhythm disorder', 'notes': 'pulmonary rhythm disorder, leading to hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'cardiac insufficiency', 'notes': 'cardiac insufficiency, both leading to hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'Gastro intestinal bleeding', 'notes': 'gastro intestinal bleeding, life threatening', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mepitel One', 'description': 'Non-Painful dressing removal, measured by VAS\n\nMepitel One\n\nUrgoTul'}, {'id': 'OG001', 'title': 'UrgoTul', 'description': 'Non-Painful dressing removal, measured by VAS\n\nMepitel One\n\nUrgoTul'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 days', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat.Participants with None painfull dressing removal.'}, {'type': 'SECONDARY', 'title': 'Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mepitel One', 'description': 'Complete healing was reported for 39 subjects ( 68,4%) in the Mepitel One group.'}, {'id': 'OG001', 'title': 'UrgoTul', 'description': 'Complete healing was reported for 27 subjects ( 49,1%) in theUrgoTul group.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.89', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '21 days', 'description': 'Complete healing at day 21, will be measured using PictZar system.', 'unitOfMeasure': 'percentage of wound size reduction', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Condition of the Wound, Will be Assesst by the Investigator.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Condition of the Wound Mepitel One', 'description': 'Condition of the wound assesed by the investigator'}, {'id': 'OG001', 'title': 'Condition of the Wound, UrgoTul', 'description': 'Condition of the wound, UrgoTul, assessed by the investigator'}], 'classes': [{'title': 'Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Maceration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Granulation tissue in growth in the dressing holes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '21 days', 'description': 'wound size estimation, assesstemnt of the wound,', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing value for some patients'}, {'type': 'SECONDARY', 'title': 'Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Mepitel One', 'description': 'Adverse Event and Adverse Device Effect'}, {'id': 'OG001', 'title': 'Safety UrgoTul', 'description': 'Adverse Event and Adverse Device Effect'}], 'classes': [{'categories': [{'title': 'Subject with Adverse Event', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Subject with Adverse Device Effect', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Subject with non AE', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '21 days', 'description': 'Adverse Event, Adverse Device Event', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assessment of the Surrounding Skin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mepitel One', 'description': 'Condition of the surrounding skin'}, {'id': 'OG001', 'title': 'UrgoTul', 'description': 'Condition of the surrounding skin'}], 'classes': [{'title': 'Inflammatory signs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Irritation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Allergic rash', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Blistering', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Skin stripping', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Maceration', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Dry', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Trauma to wound edges', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Product degradation on the skin', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hematoma', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 days', 'description': 'assessment of the surrounding skin.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mepitel One', 'description': 'Pain on dressing removal, by VAS\n\nMepitel One'}, {'id': 'FG001', 'title': 'UrgoTul', 'description': 'Pain on removal by VAS\n\nUrgoTul'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'consent withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mepitel One', 'description': 'Pain on dressing removal, by VAS\n\nMepitel One\n\nUrgoTul'}, {'id': 'BG001', 'title': 'UrgoTul', 'description': 'Pain on dressing removal, by VAS\n\nMepitel One\n\nUrgoTul'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'spread': '21.2', 'groupId': 'BG000'}, {'value': '59.8', 'spread': '23.0', 'groupId': 'BG001'}, {'value': '62.3', 'spread': '22.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-24', 'studyFirstSubmitDate': '2014-09-05', 'resultsFirstSubmitDate': '2016-05-03', 'studyFirstSubmitQcDate': '2014-09-10', 'lastUpdatePostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-24', 'studyFirstPostDateStruct': {'date': '2014-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Non-Painful Dressing Removal, Measured by Visual Aanalog Scale (VAS)', 'timeFrame': '21 days', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Complete Healing at Day 21, Will be Measured Using PictZar ( Digital Planimetric System) System.', 'timeFrame': '21 days', 'description': 'Complete healing at day 21, will be measured using PictZar system.'}, {'measure': 'Condition of the Wound, Will be Assesst by the Investigator.', 'timeFrame': '21 days', 'description': 'wound size estimation, assesstemnt of the wound,'}, {'measure': 'Safety', 'timeFrame': '21 days', 'description': 'Adverse Event, Adverse Device Event'}, {'measure': 'Assessment of the Surrounding Skin.', 'timeFrame': '21 days', 'description': 'assessment of the surrounding skin.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute', 'wound', 'management', 'measured', 'Visual analoge scale'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'To compare the effects of pain of the two dressings, Mepitel® One and UrgoTul® in acute wound management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Acute wound: traumatic wound (dermabrasion, skin tears, other), benign burn requiring the use of dressings\n2. Acute wound size between 3 cm² and 240 cm2 (wound could be covered by 2 investigational products maximum)\n3. Wound whose duration is ≤ 3 days\n4. Both gender with an age ≥ 18 years\n5. Subject able to understand and voluntarily sign the informed consent\n6. Subject able to follow the protocol\n7. Subject insured to the French social security system\n\nExclusion Criteria:\n\n1. Surgical wound\n2. Infected, moderately to strongly exudative and haemorrhagic wound\n3. Diagnosed underlying disease (e.g. diabetic neuropathy, stroke, …) which, as judged by the investigator, could interfere with the pain assessment\n4. Known allergy/hypersensitivity to any of the components of the investigational products\n5. Participation in other clinical investigation within one month prior to start of investigation\n6. Pregnant or breast-feeding women\n7. Person protected by a legal regime (tutorship or guardianship)'}, 'identificationModule': {'nctId': 'NCT02237118', 'acronym': 'Only', 'briefTitle': 'Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)"', 'organization': {'class': 'INDUSTRY', 'fullName': 'Molnlycke Health Care AB'}, 'officialTitle': 'Prospective, Randomized, Non-inferiority Investigation to Compare Effects of Mepitel® One and UrgoTul® Dressings in Acute Wound Management (Only)"', 'orgStudyIdInfo': {'id': 'MPTO 05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mepitel One', 'description': 'Pain on dressing removal, by VAS', 'interventionNames': ['Device: Mepitel One', 'Device: UrgoTul']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'UrgoTul', 'description': 'Pain on removal by VAS', 'interventionNames': ['Device: Mepitel One', 'Device: UrgoTul']}], 'interventions': [{'name': 'Mepitel One', 'type': 'DEVICE', 'armGroupLabels': ['Mepitel One', 'UrgoTul']}, {'name': 'UrgoTul', 'type': 'DEVICE', 'armGroupLabels': ['Mepitel One', 'UrgoTul']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33340', 'city': 'Lespare', 'country': 'France', 'facility': 'Clinique Mutualiste du Medoc'}], 'overallOfficials': [{'name': 'Anna Solanilla, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Mutualiste du Medoc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Molnlycke Health Care AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}