Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-05 @ 5:24 PM
Study NCT ID:
NCT03597750
Status:
COMPLETED
Last Update Posted:
2018-10-03
First Post:
2017-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Static Air Support Devices (Repose®) and Alternating-Pressure Devices in the Prevention of Pressure Ulcers
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': 308}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-02', 'studyFirstSubmitDate': '2017-10-23', 'studyFirstSubmitQcDate': '2018-07-13', 'lastUpdatePostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure ulcer incidence (Cat. II+)', 'timeFrame': '14 days', 'description': 'Development of at least 1 pressure ulcer Cat. II+ during study period'}], 'secondaryOutcomes': [{'measure': 'Patient experiences and perceptions using a static air mattress', 'timeFrame': '14 days', 'description': 'Patients experiences and perceptions of comfort using static air support devices and alternating-pressure mattresses. Patient acceptability \\[tolerance, (sleep) comfort, pain)'}, {'measure': 'Caretakers perceptions of barriers and facilitators to use static air mattress', 'timeFrame': '14 days', 'description': 'Nurses acceptability \\[barriers and facilitators\\].'}, {'measure': 'Incidence of incontinence-associated dermatitis (IAD)', 'timeFrame': '14 days', 'description': 'Development of at least 1 IAD during study period'}, {'measure': 'Cost of the intervention (Repose) versus the standard care (Alternating)', 'timeFrame': '14 days', 'description': 'Economic measures (from an organizational and patient perspective)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Static air support devices', 'Alternating-pressure devices', 'High risk population', 'Elderly', 'Prevention'], 'conditions': ['Pressure Ulcer', 'Pressure Injury', 'Pressure Sore', 'Bed Sore']}, 'referencesModule': {'references': [{'pmid': '26333288', 'type': 'BACKGROUND', 'citation': 'McInnes E, Jammali-Blasi A, Bell-Syer SE, Dumville JC, Middleton V, Cullum N. Support surfaces for pressure ulcer prevention. Cochrane Database Syst Rev. 2015 Sep 3;2015(9):CD001735. doi: 10.1002/14651858.CD001735.pub5.'}, {'pmid': '27391289', 'type': 'BACKGROUND', 'citation': 'Serraes B, Beeckman D. Static Air Support Surfaces to Prevent Pressure Injuries: A Multicenter Cohort Study in Belgian Nursing Homes. J Wound Ostomy Continence Nurs. 2016 Jul-Aug;43(4):375-8. doi: 10.1097/WON.0000000000000244.'}], 'seeAlsoLinks': [{'url': 'http://www.ucvvgent.be', 'label': 'Website of the research group'}]}, 'descriptionModule': {'briefSummary': "Maintaining and improving skin health are major goals in acute and long-term care. Patients at the extremes of age, the critically ill, medically compromised and those with immobility are at risk for developing several skin disorders, with pressure ulcers (PUs) as one of the most common and mostly preventable ones. Prevalence figures of PUs vary between 6.4% and 31.4%. PUs are described as localised injuries to the skin and/or underlying tissue, usually over a bony prominence, as a result of pressure or pressure combined with shear. Prevention of PUs is internationally seen to be a key quality indicator of care. To prevent PUs, reducing both the amount and the duration of pressure and shear at the pressure points of the body is strongly recommended. One of the interventions to achieving this, is the use of pressure-reducing devices (mattresses, cushions, etc.). Studies that compare the (cost-) effectiveness of different pressure-reducing devices are needed.\n\nThe primary aim of this study is to compare the (cost-) effectiveness of pressure ulcer prevention in high risk patients using static air support devices (Repose®) versus alternating-pressure devices. The second aim is to get insight in patients' experiences and perceptions of comfort using static air support devices and alternating-pressure devices. The third aim is to get insight in caretakers' perceptions of barriers and facilitators of the use of static air support devices and alternating-pressure devices and to reveal how these perceptions influence the readiness to use the products in clinical practice.\n\nThis randomized controlled trial will be performed in ca. 25 nursing homes in a random sample of 306 residents who are at high risk of developing pressure ulcers. Residents will be included in the study for a period of 14 days. Skin assessment and risk factor registration will be done on a daily basis by the nurses. Reliability checks and time measurements will be completed by the researcher."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High risk of pressure ulcers (Braden score \\< 12) and/or pressure ulcer category 1\n* Currently using alternating-pressure devices\n* Bedbound (\\> 8 hours in bed) or chair bound (\\> 8 hours in chair)\n* Aged \\> 65 years\n\nExclusion Criteria:\n\n* Pressure ulcer category 2,3,4, deep tissue injury (DTI) or unstageable pressure ulcer\n* Expected length of stay \\< 2 weeks\n* End of life care\n* Medical contraindication for use of static air support devices'}, 'identificationModule': {'nctId': 'NCT03597750', 'briefTitle': 'Comparison of Static Air Support Devices (Repose®) and Alternating-Pressure Devices in the Prevention of Pressure Ulcers', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Pressure Ulcer Prevention Using Static Air Support Devices (Repose®) Versus Alternating-Pressure Devices in a High Risk Population in Nursing Homes: A Multi-Center Prospective Randomized Controlled Trial and Qualitative Study', 'orgStudyIdInfo': {'id': 'EC/2017/0266'}, 'secondaryIdInfos': [{'id': 'B670201731706', 'type': 'OTHER', 'domain': 'Ethics Committee UZ Gent'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Static air support devices (Repose®)', 'description': 'Alternating-pressure devices will be replaced by static air support devices (Repose®) during 14 days:\n\n* Repose® Mattress\n* Repose® Cushion\n* Repose® Wedge or Foot Protectors\n\nThe frequency of repositioning remains unchanged.', 'interventionNames': ['Device: Repose®']}, {'type': 'NO_INTERVENTION', 'label': 'Alternating-pressure devices', 'description': 'Instead of replacing the alternating-pressure devices by static air support devices (Repose®), the residents remain on their alternating-pressure devices.\n\nThe frequency of repositioning remains unchanged.'}], 'interventions': [{'name': 'Repose®', 'type': 'DEVICE', 'description': '* Repose® Mattress\n* Repose® Cushion\n* Repose® Wedge or Foot Protectors', 'armGroupLabels': ['Static air support devices (Repose®)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aartselaar', 'state': 'Antwerpen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Zonnetij', 'geoPoint': {'lat': 51.13412, 'lon': 4.38678}}, {'city': 'Aartselaar', 'state': 'Antwerpen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Zonnewende', 'geoPoint': {'lat': 51.13412, 'lon': 4.38678}}, {'city': 'Brasschaat', 'state': 'Antwerpen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum De Mick', 'geoPoint': {'lat': 51.2912, 'lon': 4.49182}}, {'city': 'Brecht', 'state': 'Antwerpen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Sint-Maria', 'geoPoint': {'lat': 51.35024, 'lon': 4.63829}}, {'city': 'Aalter', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Veilige Have', 'geoPoint': {'lat': 51.09017, 'lon': 3.44693}}, {'city': 'Assenede', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Sint-Jozef', 'geoPoint': {'lat': 51.22598, 'lon': 3.75085}}, {'city': 'Gentbrugge', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum De Vijvers', 'geoPoint': {'lat': 51.03692, 'lon': 3.76509}}, {'city': 'Hamme', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Meulenbroek', 'geoPoint': {'lat': 51.09822, 'lon': 4.13705}}, {'city': 'Oudenaarde', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Heilig Hart', 'geoPoint': {'lat': 50.85168, 'lon': 3.60891}}, {'city': 'Zottegem', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Egmont', 'geoPoint': {'lat': 50.86955, 'lon': 3.81052}}, {'city': 'Avelgem', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Sint-Vincentius', 'geoPoint': {'lat': 50.77618, 'lon': 3.44502}}, {'city': 'Bruges', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Hallenhuis', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Bruges', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Minnewater', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Bruges', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Ter Potterie', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Bruges', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Van Zuylen', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Ieper', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Huize Zonnelied', 'geoPoint': {'lat': 50.85114, 'lon': 2.88569}}, {'city': 'Ingelmunster', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Maria Rustoord', 'geoPoint': {'lat': 50.92081, 'lon': 3.25571}}, {'city': 'Izegem', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum De Plataan', 'geoPoint': {'lat': 50.91396, 'lon': 3.21378}}, {'city': 'Kortrijk', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum De Pottelberg', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'city': 'Kortrijk', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Sint-Jozef', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'city': 'Poperinge', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum OLV Gasthuis', 'geoPoint': {'lat': 50.85386, 'lon': 2.72659}}, {'city': 'Reninge', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Hof Ten Ijzer', 'geoPoint': {'lat': 50.94781, 'lon': 2.78892}}, {'city': 'Vlamertinge', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Wintershove', 'geoPoint': {'lat': 50.85485, 'lon': 2.82024}}, {'city': 'Waregem', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum De Meers', 'geoPoint': {'lat': 50.88898, 'lon': 3.42756}}, {'city': 'Wevelgem', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Sint-Camillus', 'geoPoint': {'lat': 50.8, 'lon': 3.16667}}, {'city': 'Zwevegem', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'Woonzorgcentrum Sint-Amand', 'geoPoint': {'lat': 50.81268, 'lon': 3.33848}}], 'overallOfficials': [{'name': 'Dimitri Beeckman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Frontier Medical Group, UK', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University Centre for Nursing and Midwifery', 'investigatorFullName': 'UCVV', 'investigatorAffiliation': 'University Ghent'}}}}