Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-29 @ 12:28 AM
Study NCT ID:
NCT01191567
Status:
TERMINATED
Last Update Posted:
2017-11-17
First Post:
2010-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'insufficient recruitement speed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-15', 'studyFirstSubmitDate': '2010-08-26', 'studyFirstSubmitQcDate': '2010-08-30', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'treatment results', 'timeFrame': '2 weeks', 'description': 'successfully treated or non-successfully treated'}, {'measure': 'wound size', 'timeFrame': '2 weeks', 'description': 'meassured with Visitrak'}, {'measure': 'Quality of life', 'timeFrame': '2 weeks', 'description': 'meassured with EQ-5D form and a diary with content analysis'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '2 weeks'}, {'measure': 'costs for treatment', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute wounds', 'postoperative wounds'], 'conditions': ['Wounds']}, 'descriptionModule': {'briefSummary': "Wounds have long been a source of suffering for unfortunate victims and in recent years new complementary methods have been developed in areas where traditional wound treatment has been insufficient. Treating wounds with negative pressure, Vacuum assisted closure® \\[VAC\\], is a relatively new method of treatment and knowledge about its effect on patients is limited.\n\nEarlier studies haven't been able to answer the question about which groups of patients that are in most favour of the treatment and what impact the treatment has on the patient's quality of life.\n\nIt is important with further research since an effective and mild wound treatment can decrease suffering and increase quality of life for the patient. Wound treatment that does not lead to an achieved treatment goal can lead to a risk for the patient and should be avoided.\n\nThe project consists of 4 part studies: Study 1 and 2 are chart review studies of a consecutive series of patients treated with VAC at Södersjukhuset during a 3 year period. The patients are described on the basis of medical, surgical and demographical factors. Outcome is treatment results and risk factors for a treatment failure.\n\nStudy 3 and 4 are clinical randomised studies with the aim of studying whether treatment with VAC provides a faster and more effective healing of acute and postoperative wounds, and in what way the treatment affect the quality of life and pain of the patients, compared to conventional treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute wounds with substance defect after primary suture demanding further treatment or wounds not primary sutured\n* wounds with osteosynthesis, bone or tendon visual regardless wound size\n* postoperative infections with wound and substance defect demanding further treatment.\n* fasciotomy on extremity\n\nExclusion Criteria:\n\n* wound size \\< 2 cm and depth \\< 1 cm\n* pressure ulcers, open abdomen and chronic ulcers\n* patients with dementia or mental illness so severe that participation in the study is impossible\n* patients non in command of the swedish language\n* ongoing treatment with warfarin'}, 'identificationModule': {'nctId': 'NCT01191567', 'briefTitle': "Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life", 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': "Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life", 'orgStudyIdInfo': {'id': '2008/2023-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional treatment', 'interventionNames': ['Procedure: Conventional treatment']}, {'type': 'EXPERIMENTAL', 'label': 'VAC treatment', 'interventionNames': ['Procedure: VAC treatment']}], 'interventions': [{'name': 'VAC treatment', 'type': 'PROCEDURE', 'description': 'wound treatment with VAC-therapy', 'armGroupLabels': ['VAC treatment']}, {'name': 'Conventional treatment', 'type': 'PROCEDURE', 'description': 'wound treatment with conventional treatment according to the hospitals local routines', 'armGroupLabels': ['Conventional treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11883', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Södersjukhuset', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stockholm South General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN, PhD', 'investigatorFullName': 'Ann-Mari Wallin', 'investigatorAffiliation': 'Karolinska Institutet'}}}}