Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-17 @ 8:22 AM
Study NCT ID:
NCT02380820
Status:
COMPLETED
Last Update Posted:
2016-04-11
First Post:
2015-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Measurements of Interface Pressures Between Two Pressure-ulcer Prevention Mattresses: Softform Premier and Airsoft Duo
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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-08', 'studyFirstSubmitDate': '2015-02-23', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age (years)', 'timeFrame': 'Baseline (Day 0)'}, {'measure': 'Sex (F/M)', 'timeFrame': 'Baseline (Day 0)'}, {'measure': 'Weight (kg)', 'timeFrame': 'Baseline (Day 0)'}, {'measure': 'Height (cm)', 'timeFrame': 'Baseline (Day 0)'}, {'measure': 'Body mass index (kg/m^2)', 'timeFrame': 'Baseline (Day 0)'}, {'measure': 'Norton risk score', 'timeFrame': 'Baseline (Day 0)'}, {'measure': 'Albuminemia', 'timeFrame': 'Baseline (Day 0)'}], 'primaryOutcomes': [{'measure': 'Interface pressure in the sacral zone (mm Hg) as measured by a Model X3 sensor pressure captor sheet', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Contact surface area (cm^2) as measured by a Model X3 sensor pressure captor sheet', 'timeFrame': 'Day 1'}, {'measure': 'Interface pressure at the heel (mm Hg) as measured by a Model X3 sensor pressure captor sheet', 'timeFrame': 'Day 1'}, {'measure': 'Presence/absence of a pressure ulcer over the past month', 'timeFrame': '1 month'}, {'measure': 'Patient-rated comfort as measured by the visual analog scale', 'timeFrame': '1 month', 'description': 'Visual analog scale ranging from 0 to 10'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mattress', 'Preventing bed sores', 'Skin pressure'], 'conditions': ['Pressure Ulcer']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to compare the Softform Premier mattress (in static mode) and AIRSOFT DUO mattresses in terms of skin pressures measured at the sacral area.', 'detailedDescription': 'The secondary objectives of the study are to compare the two devices in terms of:\n\nA. contact surface. B. heel pressure. C. On the occurrence of pressure ulcers anywhere on the body at month 1. D. patient comfort after 1 month (visual analog scale ranging from 1 to 10).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient must have given his/her informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient spends more than 12 hours in bed with a possible verticalization and a predictable length of stay of at least 1 month.\n* The patient has a stable medical condition (no complications in the last 10 days) without pressure ulcers\n* The patient is at risk of pressure ulcers assessed a score ≤ 14 on the Norton scale\n* The patient's weight is less than 120 Kg\n\nExclusion Criteria:\n\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient refuses to sign the consent\n* It is impossible to correctly inform the patient\n* Contra-indication for strict decubitus dorsal position\n* The patient has a rotation of the pelvis, asymmetric deformations of the hips in the frontal plane.\n* The patient has bedsores, a recent scar in a pressure area.\n* The patient has a knee flexion deformity\\> 10 °\n* The patient is agitated or uncooperative\n* The patient's weight is greater than 120 Kg"}, 'identificationModule': {'nctId': 'NCT02380820', 'acronym': 'SPA2-INVACARE', 'briefTitle': 'Comparative Measurements of Interface Pressures Between Two Pressure-ulcer Prevention Mattresses: Softform Premier and Airsoft Duo', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Comparative Measurements of Interface Pressures Between Two Pressure-ulcer Prevention Mattresses: Softform Premier and Airsoft Duo', 'orgStudyIdInfo': {'id': 'LOCAL/2014/CEDMH-01'}, 'secondaryIdInfos': [{'id': '2014-A01214-43', 'type': 'OTHER', 'domain': 'RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AirsoftDuo first', 'description': 'Patients randomized to this arm will be placed on the Airsoft Duo mattress, and the investigator will proceed with 2 series (for reproductibility) of measures for 30 minutes with the bed headboard at 0°. A pause, consisting of ten minutes of sitting and 1 minute of verticalization is then carried out. The bed is then positioned at 30°, and the 2 series of measures over 30 minutes are repeated. The next day, all of the above are repeated with the Softform Premium mattress (in static mode). The patient will then continue his/her stay with the Softform Premium mattress (in static mode) for 1 month.\n\nIntervention: Airsoft Duo mattress Intervention: Softform Premier mattress (in static mode)', 'interventionNames': ['Device: Airsoft Duo mattress', 'Device: Softform Premier mattress (in static mode)']}, {'type': 'EXPERIMENTAL', 'label': 'Softform Premium first', 'description': 'Patients randomized to this arm will be placed on the Softform Premium mattress (in static mode), and the investigator will proceed with 2 series (for reproductibility) of measures for 30 minutes with the bed headboard at 0°. A pause, consisting of ten minutes of sitting and 1 minute of verticalization is then carried out. The bed is then positioned at 30°, and the 2 series of measures over 30 minutes are repeated. The next day, all of the above are repeated with the Airsoft Duo mattress. The patient will then continue his/her stay with the Airsoft Duo mattress for 1 month.\n\nIntervention: Softform Premier mattress (in static mode) Intervention: Airsoft Duo mattress', 'interventionNames': ['Device: Airsoft Duo mattress', 'Device: Softform Premier mattress (in static mode)']}], 'interventions': [{'name': 'Airsoft Duo mattress', 'type': 'DEVICE', 'description': 'A multi-layer mattress for pressure sore prevention. Made by NAUER FOAMPARTNER AG et OBA AG (Germany).', 'armGroupLabels': ['AirsoftDuo first', 'Softform Premium first']}, {'name': 'Softform Premier mattress (in static mode)', 'type': 'DEVICE', 'description': 'A multi-layer mattress for pressure sore prevention. Made by INVACARE MSS (United Kingdom).', 'armGroupLabels': ['AirsoftDuo first', 'Softform Premium first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85610', 'city': 'Cugan Montaigu Cedex', 'country': 'France', 'facility': 'EHPAD La Chimotaie'}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHRU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '30340', 'city': 'Saint-Privat-des-Vieux', 'country': 'France', 'facility': 'EHPAD Notre Dame des Pins', 'geoPoint': {'lat': 44.14435, 'lon': 4.12885}}], 'overallOfficials': [{'name': 'Emilie Viollet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'collaborators': [{'name': 'Invacare Poirier S.A.S.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}