Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-01-24 @ 11:19 PM
Study NCT ID:
NCT02735135
Status:
WITHDRAWN
Last Update Posted:
2019-04-25
First Post:
2016-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of 2 Mattresses for the Prevention of Bedsores by Measuring Skin Pressure in the Sacral Area
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{'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'methodological difficulties', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-24', 'studyFirstSubmitDate': '2016-04-07', 'studyFirstSubmitQcDate': '2016-04-07', 'lastUpdatePostDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak interface pressures at the sacral area (mmHg)', 'timeFrame': 'Day 0'}, {'measure': 'Peak interface pressures at the sacral area (mmHg)', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Body contact surface area (cm^2)', 'timeFrame': 'Day 0'}, {'measure': 'Body contact surface area (cm^2)', 'timeFrame': 'Day 1'}, {'measure': 'Peak pressure at the heel area (mmHg)', 'timeFrame': 'Day 0'}, {'measure': 'Peak pressure at the heel area (mmHg)', 'timeFrame': 'Day 1'}, {'measure': 'Pressure ulcer development (yes/no)', 'timeFrame': 'Month 1'}, {'measure': 'Self-assessment of comfort by the patient (visual analog scale)', 'timeFrame': 'Month 1'}, {'measure': 'Self-assessment for noise (Likert scale)', 'timeFrame': 'Month 1'}, {'measure': 'Self-assessment of sleep quality (visual analog scale)', 'timeFrame': 'Month 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bedridden'], 'conditions': ['Pressure Ulcer']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to compare the AIRSOFT DUO and the SENTRY 1200 constant pressure mattresses in terms of peak 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. body contact surface area. B. peak pressure at the heel area (combining right and left heels) C. occurrence of pressure ulcers anywhere on the body for 1 month D. patient comfort rated at 1 month (visual analog scale varying from 0-10) E. noise (Likert Scale). F. sleep quality (visual analog scale varying from 0-10).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 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 and verticalisation is possible\n* The patient has a stable medical condition (no complication in the last 10 days) and no visible pressure ulcers\n* The patient is at risk for pressure ulcers as assessed by a score ≤ 15 on the Braden Scale\n* The patient weighs 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* The subject has a contra-indication for a strictly supine position\n* The patient has a knee flexion deformity \\> 10 °\n* The patient is in a state of agitation or refuses to cooperate\n* The patient's weight is greater than 120 Kg\n* The length of stay is less than one month"}, 'identificationModule': {'nctId': 'NCT02735135', 'acronym': 'SPA2-ARSFT-DUO', 'briefTitle': 'Comparison of 2 Mattresses for the Prevention of Bedsores by Measuring Skin Pressure in the Sacral Area', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Comparison of 2 Mattresses for the Prevention of Bedsores, AIRSOFT DUO and SENTRY 1200 A PRESSION CONSTANTE, by Measuring Skin Pressure in the Sacral Area - a Multicenter Crossover Study', 'orgStudyIdInfo': {'id': 'LOCAL/2016/CEDMH-01'}, 'secondaryIdInfos': [{'id': '2016-A00188-43', 'type': 'OTHER', 'domain': 'RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Airsoft Duo First', 'description': 'Patients randomized to this arm will be placed on an AIRSOFT DUO mattress for day 0. They will then be switched to a SENTRY 1200 mattress until the end of month 1.\n\nIntervention: AIRSOFT DUO for 1 day Intervention: SENTRY 1200 for 1 month', 'interventionNames': ['Device: AIRSOFT DUO for 1 day', 'Device: SENTRY 1200 for 1 month']}, {'type': 'EXPERIMENTAL', 'label': 'SENTRY 1200 First', 'description': 'Patients randomized to this arm will be placed on a SENTRY 1200 mattress for day 0. They will then be switched to an AIRSOFT DUO mattress until the end of month 1.\n\nIntervention: SENTRY 1200 for 1 day Intervention: AIRSOFT DUO for 1 month', 'interventionNames': ['Device: SENTRY 1200 for 1 day', 'Device: AIRSOFT DUO for 1 month']}], 'interventions': [{'name': 'AIRSOFT DUO for 1 day', 'type': 'DEVICE', 'description': 'The patient is placed on an AIRSOFT DUO mattress for 1 day.', 'armGroupLabels': ['Airsoft Duo First']}, {'name': 'SENTRY 1200 for 1 month', 'type': 'DEVICE', 'description': 'The patient is placed on a SENTRY 1200 mattress for 1 month.', 'armGroupLabels': ['Airsoft Duo First']}, {'name': 'SENTRY 1200 for 1 day', 'type': 'DEVICE', 'description': 'The patient is placed on a SENTRY 1200 mattress for 1 day.', 'armGroupLabels': ['SENTRY 1200 First']}, {'name': 'AIRSOFT DUO for 1 month', 'type': 'DEVICE', 'description': 'The patient is placed on an AIRSOFT DUO mattress for 1 month.', 'armGroupLabels': ['SENTRY 1200 First']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34525', 'city': 'Béziers', 'country': 'France', 'facility': 'CH de Beziers', 'geoPoint': {'lat': 43.34122, 'lon': 3.21402}}, {'zip': '06250', 'city': 'Mougins', 'country': 'France', 'facility': 'Clinique de Soins de suite et réadaptation Saint Basile', 'geoPoint': {'lat': 43.60068, 'lon': 6.99523}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHRU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Emilie Viollet, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'collaborators': [{'name': 'Annie Bauer Confort', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}