Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-03-09 @ 12:20 AM
Study NCT ID:
NCT01640418
Status:
COMPLETED
Last Update Posted:
2015-07-21
First Post:
2012-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Sacral Pressure Ulcers With Preventive Dressings
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 253}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-20', 'studyFirstSubmitDate': '2012-07-11', 'studyFirstSubmitQcDate': '2012-07-11', 'lastUpdatePostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the number of patients who develop sacral pressure ulcers between the group with the Mepilex® Border Sacrum dressings (Group A) and the group without any sacral dressings (Group B).', 'timeFrame': '8 weeks', 'description': 'till hospital release, max 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pressure ulcer', 'dressing', 'prevention', 'higher risk patients'], 'conditions': ['Grade I to Grade IV Pressure Ulcers in Higher Risk Patients']}, 'descriptionModule': {'briefSummary': 'In this study we would like to find a way to prevent sacral pressure ulcers in high-risk patients by the use of a Mepilex sacral dressing. The research question we would like to answer is the following: Is the Mepilex sacral dressing a cost-effective dressing for the prevention of grade I to grade IV pressure ulcers in the sacral region in higher-risk hospitalized patients?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: ≥18 years\n* Admission in one of the ten high-risk departments of the azM\n* Suspected hospital stay of 5 days or more after admission\n* Braden score 19 or less\n\nExclusion Criteria:\n\n* Age: \\<18 years\n* Pre-existing sacral pressure ulcer\n* Pre-existing trauma to the sacrum\n* Patient is unable to speak Dutch\n* Patients with an inability to give informed consent\n* Patients who are unable to give informed consent within 24h after admission\n* Patients who are unable to give informed consent before surgery'}, 'identificationModule': {'nctId': 'NCT01640418', 'acronym': 'SACRESS', 'briefTitle': 'Prevention of Sacral Pressure Ulcers With Preventive Dressings', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'orgStudyIdInfo': {'id': 'NL40299.068.12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mepilex® Border Sacrum dressings', 'description': 'Mepilex® Border Sacrum dressings', 'interventionNames': ['Device: Mepilex® Border Sacrum dressings']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Standard Care'}], 'interventions': [{'name': 'Mepilex® Border Sacrum dressings', 'type': 'DEVICE', 'description': 'Mepilex® Border Sacrum dressings', 'armGroupLabels': ['Mepilex® Border Sacrum dressings']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229 HX', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Academic Hospital of Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Nicole Bouvy', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academic Hospital of Maastricht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}