Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-30 @ 11:52 PM
Study NCT ID:
NCT05619003
Status:
COMPLETED
Last Update Posted:
2025-09-10
First Post:
2022-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dkcpov@coloplast.com', 'phone': '+45 49112880', 'title': 'Senior Scientific Manager', 'organization': 'Coloplast'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from baseline (day 1, visit 1) and at all daily visits until termination visit (latest after 7 days). There was no follow-up after study termination.', 'eventGroups': [{'id': 'EG000', 'title': 'Biatain Silicone Sacral Dressing', 'description': '67 patients were treated with Biatain Silicone Sacral dressing over the bony prominence of the sacral area as part of a pressure injury prevention protocol', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 5, 'seriousNumAtRisk': 67, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Incision site pain', 'notes': 'All events assessed as not related to the investigational device by the investigator', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Dyspnoea', 'notes': 'Worsening of shortness of breath. Event assessed as not related to the investigational device by the investigator', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'notes': 'Patient admitted with end stage cirrhosis or cancer of the liver. Event assessed as not related to the investigational device by the investigator', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspiration', 'notes': 'Aspiration to the lungs in conjunction with gastroscopy. Event assessed as not related to the investigational device by the investigator', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intraabdominal bleeding', 'notes': 'patient experienced intraabdominal bleeding following a total colectomy due to ulcerative colitis.\n\nEvent assessed as not related to the investigational device by the investigator', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biatain Silicone Sacral Dressing', 'description': 'Biatain Silicone Sacral will be applied over the bony prominence of the sacral area'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'description': 'Evaluate the safety of Biatain Silicone Sacral. Adverse events considered related to the investigational device by the investigator during the investigation period (up to 7 days or until discharged)', 'unitOfMeasure': 'Adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Device Deficiencies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biatain Silicone Sacral Dressing', 'description': 'Biatain Silicone Sacral dressing will be applied over the bony prominence of the sacral area'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'description': 'Evaluate the safety of Biatain Silicone Sacral. Number of device deficiencies during the investigation period (up to 7 days or until discharged)', 'unitOfMeasure': 'Device deficiencies', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Biatain Silicone Sacral Dressing', 'description': 'Biatain Silicone Sacral will be applied over the bony prominence of the sacral area'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Biatain Silicone Sacral Dressing', 'description': 'Biatain Silicone Sacral will be applied over the bony prominence of the sacral area'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '70.5', 'groupId': 'BG000', 'lowerLimit': '46', 'upperLimit': '92'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27.4', 'groupId': 'BG000', 'lowerLimit': '15', 'upperLimit': '50'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Urinary incontinence', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Faecal incontinence', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Braden Scale Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'BG000', 'lowerLimit': '11', 'upperLimit': '18'}]}]}], 'paramType': 'MEAN', 'description': "The Braden Scale is a standardized assessment tool used in healthcare to assess a patient's risk for developing pressure injuries. The total Braden Scale score ranges from 6 to 23, with lower scores indicating higher susceptibility to pressure ulcers", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Numbers of participants constitutes the ITT population (participants exposed to the investigational device with information on at least one endpoint) and differ from the overall (safety population constituted by all subjects with a valid informed consent)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-28', 'size': 1658638, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-02T08:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-labelled, non-comparative, single-arm, prospective, multi-center investigation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2022-11-04', 'resultsFirstSubmitDate': '2024-05-08', 'studyFirstSubmitQcDate': '2022-11-15', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-08', 'studyFirstPostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Adverse Events', 'timeFrame': '7 days', 'description': 'Evaluate the safety of Biatain Silicone Sacral. Adverse events considered related to the investigational device by the investigator during the investigation period (up to 7 days or until discharged)'}], 'secondaryOutcomes': [{'measure': 'Number of Device Deficiencies', 'timeFrame': '7 days', 'description': 'Evaluate the safety of Biatain Silicone Sacral. Number of device deficiencies during the investigation period (up to 7 days or until discharged)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pressure Injury Prevention']}, 'descriptionModule': {'briefSummary': 'A post market clinical follow-up study investigating the safety of Biatain Silicone Sacral while used as prevention in hospital admitted patients at risk of developing a pressure injury.', 'detailedDescription': 'The investigation was a multi-centre, open label, non-comparative, single-arm, prospective study, conducted at three investigational sites in Danish hospitals. 67 hospital-admitted patients were enrolled in the study over a 3-month recruitment period. The target population were patients ≥18 years of age with an expected hospital-stay of more than 24 hours from baseline and a Braden score of 6-18.\n\nAt daily visits skin inspections for signs of non-blanchable erythema or sacral pressure injury were performed by partial lift and reapplication of the dressing. After 7 days, or earlier if the patient was discharged, a termination visit was performed. Skin assessment was performed upon removal of the dressing and a termination form completed. Information regarding adverse events and device deficiencies were collected at all visits.\n\nThere were no follow-up visits after termination of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospital-admitted patients at risk of developing a pressure injury with an expected hospital-stay of more than 24 hours from visit 1\n* ≥18 years of age and has full legal capacity\n* Has given written consent to participate by signing the Informed Consent signature Form\n* Has a Braden score of 6-18 at screening (performed within the last 24 hours)\n* Intact sacral skin (non-breached skin, without signs of non-blanchable erythema over bony prominence/pre-existing sacral pressure injury over bony prominence)\n\nExclusion Criteria:\n\n* Suspected or actual spinal injury precluding the patient from being turned\n* Sacral erythema, sacral pressure marks, pre-existing sacral pressure injury\n* Trauma to sacrum\n* Topical treatment with steroid creme in the sacral area (treatment must have been terminated at least 14 days prior to enrollment)\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT05619003', 'briefTitle': 'Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at Risk', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'A Prospective Single-arm Study Investigating the Safety of Biatain Silicone Sacral While Used as Prevention in Hospital-admitted Patients at Risk of Developing a Pressure Injury', 'orgStudyIdInfo': {'id': 'CP346'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biatain Silicone Sacral Dressing', 'interventionNames': ['Device: Biatain Silicone Sacral dressing']}], 'interventions': [{'name': 'Biatain Silicone Sacral dressing', 'type': 'DEVICE', 'description': 'Biatain Silicone Sacral dressing will be applied over the bony prominence of the sacral area as part of a PIP (Pressure Injury Prevention) protocol in patients at risk', 'armGroupLabels': ['Biatain Silicone Sacral Dressing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Hvidovre Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Christina Overgaard, SSM', 'role': 'STUDY_CHAIR', 'affiliation': 'Coloplast A/S'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}