Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2026-02-21 @ 9:59 PM
Study NCT ID:
NCT02295735
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2014-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jan.kottner@charite.de', 'phone': '+4930450518218', 'title': 'PD Dr. Jan Kottner', 'organization': 'Charité Universitätsmedizin Berlin, Department of Dermatology and Allergy'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded every day until the Patient was discharged from the Hospital,an average of 12.6 (SD +/-12.7) days', 'description': 'Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device.\n\nNote: This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved. For users or other persons, this definition is restricted to events related to investigational medical devices.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention Group', 'description': 'For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.', 'otherNumAtRisk': 212, 'deathsNumAtRisk': 212, 'otherNumAffected': 2, 'seriousNumAtRisk': 212, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'Standard pressure ulcer prevention according to hospital standard', 'otherNumAtRisk': 210, 'deathsNumAtRisk': 210, 'otherNumAffected': 0, 'seriousNumAtRisk': 210, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Burning pain and warm sensation under the sacral dressing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peeling of the outer layers of the skin under the sacral dressing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0.47'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard pressure ulcer prevention according to hospital standard'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': 'The primary outcome was the cumulative incidence of Pressure ulcer category II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcers were categorized according to the NPUAP/EPUAP 2014 classification System. The occurrence of a new pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)', 'unitOfMeasure': 'Pressure ulcer', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Density Rate of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard pressure ulcer prevention according to hospital standard'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '30.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': 'The Incidence density of Pressure Ulcer category II, III, IV, unstageable and DTI at heels or sacrum was measured. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)', 'unitOfMeasure': 'Proportion developed / 1000 bed days', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Pressure Ulcer Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard pressure ulcer prevention according to hospital standard'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': 'The the cumulative incidence of Pressure ulcer category I, II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)', 'unitOfMeasure': 'Pressure ulcer', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Pressure Ulcers Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard pressure ulcer prevention according to hospital standard'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '37.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': 'The Incidence density of Pressure Ulcer category I, II, III, IV, unstageable and DTI at heels or sacrum was measured. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)', 'unitOfMeasure': 'Proportion developed / 1000 bed days', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Preventive Sacrum Dressings Used for Pressure Ulcer Prevention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard pressure ulcer prevention according to hospital standard'}], 'classes': [{'categories': [{'measurements': [{'value': '1050', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': 'Number of preventive sacrum dressings used for pressure ulcer prevention', 'unitOfMeasure': 'Dressings', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Numbers of Support Surface Used for Pressure Ulcer Prevention (Total)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard pressure ulcer prevention according to hospital standard'}], 'classes': [{'title': 'Total numbers of support surfaces used', 'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}]}, {'title': 'non-powered systems', 'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'powered - alternating Systems', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}, {'title': 'powered - low-air-loss Systems', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': 'Support surface categories were recorded. Please see the different types in the Outcome measure data table', 'unitOfMeasure': 'number of support surfaces used', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Pressure Ulcer Development of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard pressure ulcer prevention according to hospital standard'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '13.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': '• Time to Pressure ulcer development in days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Preventive Heel Dressings Used for Pressure Ulcer Prevention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard pressure ulcer prevention according to hospital standard'}], 'classes': [{'categories': [{'measurements': [{'value': '2260', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': 'Number of preventive heel dressings used for pressure ulcer prevention', 'unitOfMeasure': 'Dressings', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Pressure Ulcer Development of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard pressure ulcer prevention according to hospital standard'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '12.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': '• Time to Pressure ulcer development in days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Event Free Survival Time of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard pressure ulcer prevention according to hospital standard'}], 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '89.0', 'spread': '9.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': '• Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Event Free Survival Time of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard pressure ulcer prevention according to hospital standard'}], 'classes': [{'categories': [{'measurements': [{'value': '60.7', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '54.6', 'spread': '9.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': '• Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Follow up Period of Included ICU Patients (Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Group', 'description': 'For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Standard pressure ulcer prevention according to hospital standard'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '14.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': 'Follow up period of included ICU patients in mean (days)', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Group', 'description': 'For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'Standard pressure ulcer prevention according to hospital standard'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '238'}, {'groupId': 'FG001', 'numSubjects': '237'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212'}, {'groupId': 'FG001', 'numSubjects': '210'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '27'}]}]}], 'recruitmentDetails': 'The study was conducted in a tertiary care hospital from June 2015 to July 2018 at the Charite Universitaetsmedizin Berlin, Germany. Patients were recruited from seven ICUs.\n\nIn total, 7575 ICU patients were screened for eligibility and 475 ICU patients were included.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '422', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Group', 'description': 'For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'Standard pressure ulcer prevention according to hospital standard'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '422', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.8', 'spread': '15.6', 'groupId': 'BG000'}, {'value': '63.1', 'spread': '15.2', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '15.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '422', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '422', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '422', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.4', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '26.6', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '26.5', 'spread': '4.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The analyzed Population differs from the Overall due to missing data'}, {'title': 'Braden scale score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '422', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.9', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '9.0', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '8.9', 'spread': '1.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Braden scale is a standardized six item Pressure ulcer risk assessment instrument with scores ranging from 6 (= high Pressure ulcer risk) to 23 (= no Pressure ulcer risk).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High Pressure ulcer risk', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '422', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'According to Hospital Standard', 'unitOfMeasure': 'Participants'}, {'title': 'Very high Pressure ulcer risk', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '422', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '383', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'According to Hospital Standard', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-09-29', 'size': 2683827, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-11T07:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 475}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-18', 'studyFirstSubmitDate': '2014-11-10', 'resultsFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2014-11-17', 'lastUpdatePostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-18', 'studyFirstPostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': 'The primary outcome was the cumulative incidence of Pressure ulcer category II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcers were categorized according to the NPUAP/EPUAP 2014 classification System. The occurrence of a new pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)'}], 'secondaryOutcomes': [{'measure': 'Density Rate of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate)', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': 'The Incidence density of Pressure Ulcer category II, III, IV, unstageable and DTI at heels or sacrum was measured. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)'}, {'measure': 'Number of Pressure Ulcer Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion)', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': 'The the cumulative incidence of Pressure ulcer category I, II, III, IV, unstageable and DTI at heels or sacrum. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)'}, {'measure': 'Number of Pressure Ulcers Category I (Non-blanchable Erythema) II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Proportion Per 1000 Bed Days, Rate)', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': 'The Incidence density of Pressure Ulcer category I, II, III, IV, unstageable and DTI at heels or sacrum was measured. Pressure ulcer were categorized according to the NPUAP/EPUAP 2014 classification system. The occurrence of a new Pressure ulcer of any category was assessed and documented daily during the study period. The Categories are defined as follows: Category I (nonblanchable erythema); Category II (Partial thickness Skin loss); Category III (Full Thickness Skin loss); Category IV (Full Thickness tissue loss); Unstageable (Depth unknown); Deep tissue injury (suspected Deep tissue injury, Depth unknown)'}, {'measure': 'Number of Preventive Sacrum Dressings Used for Pressure Ulcer Prevention', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': 'Number of preventive sacrum dressings used for pressure ulcer prevention'}, {'measure': 'Numbers of Support Surface Used for Pressure Ulcer Prevention (Total)', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': 'Support surface categories were recorded. Please see the different types in the Outcome measure data table'}, {'measure': 'Time to Pressure Ulcer Development of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': '• Time to Pressure ulcer development in days'}, {'measure': 'Number of Preventive Heel Dressings Used for Pressure Ulcer Prevention', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': 'Number of preventive heel dressings used for pressure ulcer prevention'}, {'measure': 'Time to Pressure Ulcer Development of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': '• Time to Pressure ulcer development in days'}, {'measure': 'Event Free Survival Time of Pressure Ulcers Category II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis)', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': '• Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in days'}, {'measure': 'Event Free Survival Time of Pressure Ulcers Category I, II, III, IV, Unstageable, Deep Tissue Injury (DTI) at Heels and/or Sacrum (Days, Kaplan Meier Analysis)', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': '• Estimation of the Survival function and measure of the length of time the ICU patients remained Pressure ulcer free in days'}, {'measure': 'Follow up Period of Included ICU Patients (Days)', 'timeFrame': 'Duration of hospital stay, an average of 12.6 (SD +/-12.7) days', 'description': 'Follow up period of included ICU patients in mean (days)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Skin, safety, wounds, intensive care'], 'conditions': ['Pressure Ulcer']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled trial is to test the efficacy of preventive dressings for pressure ulcer prevention.', 'detailedDescription': 'Patients of intensive acute care and residents of institutional long-term care facilities are at high risk for developing pressure ulcers (PUs). PU standard prevention includes repositioning, early mobilization and the use of special support surfaces. The use of prophylactic dressings might reduce friction and shear forces and/or modify the microclimate of the skin and might therefore protect the skin and underlying tissues from pressure/deformation injury. The primary objective of this study is to determine if preventive silicone dressings (Mepilex® border) applied to the heels and to the sacrum in addition to PU standard prevention reduces PU incidence category II, III, IV, and deep tissue injury compared to PU standard alone in at risk hospital patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Major trauma patients and/or critically ill patients (e.g. with cardiac arrest) admitted to the emergency department and being transferred and/or admitted directly to a surgical or internal ICU\n* Being at "high" or "very high" PU risk according to the Charité PU prevention standard:\n\n \\- Category 3 (= partly care dependent/limited mobility in bed), 4A (= care depended, limited mobility in bed), 4B (= totally immobile) according to the Jones classification modified by Charité\n* Expected minimum length of stay at least three days\n* Informed consent (or by legal representative)'}, 'identificationModule': {'nctId': 'NCT02295735', 'briefTitle': 'Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'A Randomized Controlled Parallel-group Trial to Investigate the Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer Prevention Compared to no Dressings', 'orgStudyIdInfo': {'id': 'CRC-PU-A-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mepilex® Border', 'description': 'If a patient is assigned to the intervention group the dressings Mepilex® Border Sacrum and Mepilex® Border Heel will be applied onto the respective intact skin areas in addition to standard pressure ulcer prevention', 'interventionNames': ['Device: Mepilex® Border Sacrum and Mepilex® Border Heel']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard pressure ulcer prevention according to hospital standard'}], 'interventions': [{'name': 'Mepilex® Border Sacrum and Mepilex® Border Heel', 'type': 'DEVICE', 'armGroupLabels': ['Mepilex® Border']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité-Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Jan Kottner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PD Dr. Jan Kottner', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PD Dr. rer cur', 'investigatorFullName': 'PD Dr. Jan Kottner', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}