Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-02-25 @ 6:42 PM
Study NCT ID:
NCT02901405
Status:
TERMINATED
Last Update Posted:
2021-11-26
First Post:
2016-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Negative Pressure Dressing Therapy in Soft Tissue Sarcoma Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054843', 'term': 'Negative-Pressure Wound Therapy'}], 'ancestors': [{'id': 'D004322', 'term': 'Drainage'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058106', 'term': 'Wound Closure Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'The study was unable to meet recruitment targets', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-16', 'studyFirstSubmitDate': '2016-09-01', 'studyFirstSubmitQcDate': '2016-09-10', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Site Infection (proportion)', 'timeFrame': '30 days', 'description': 'As diagnosed by independent observer according to the Healthcare Protection Agency (UK) guidelines'}], 'secondaryOutcomes': [{'measure': 'Time to wound dryness (nominal scale)', 'timeFrame': '30 days', 'description': 'Time to the nearest 12 hour period by which there is no further wound exudate (e.g. staining on dressing)'}, {'measure': 'Delay to discharge form hospital (nominal scale)', 'timeFrame': '30 days', 'description': 'Number of additional hospital stays attributable to wound issues'}, {'measure': 'Adverse events (count)', 'timeFrame': '30 days', 'description': 'Number of unanticipated events'}, {'measure': 'Cost analysis (comparative nominal scale in £)', 'timeFrame': '30 days', 'description': 'Cost analysis to evaluate potential offset of costs for NPWT'}]}, 'conditionsModule': {'keywords': ['sarcoma', 'infection', 'negative pressure'], 'conditions': ['Sarcoma', 'Wound Infection']}, 'descriptionModule': {'briefSummary': 'This randomised controlled trial aims to evaluate the difference in surgical site infection following excision of soft tissue sarcomas. The intervention is a negative wound pressure therapy dressing for 120 hours, the control is standard absorbent dressings', 'detailedDescription': 'Hypothesis: The application of a negative pressure wound therapy (NPWT) dressing will reduce rates of wound breakdown in patients with resection of soft tissue sarcomas which are primarily closed.\n\nPatients will be randomised into either NPWT or standard absorbent dressings with primary outcome measure of surgical site infection according to the Health Protection Agency guidance. Secondary outcomes are; time to wound dryness, delayed discharge from hospital, adverse events, cost estimation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults undergoing primary soft tissue sarcoma excision which is primarily closed.\n\nExclusion Criteria:\n\n* Unable to consent\n* Children\n* Post radiation sarcomas or sarcoma in presence of active infection\n* Multiple metastatic disease\n* Presence of Endoprosthesis'}, 'identificationModule': {'nctId': 'NCT02901405', 'briefTitle': 'Negative Pressure Dressing Therapy in Soft Tissue Sarcoma Surgery', 'organization': {'class': 'OTHER', 'fullName': 'NHS Greater Glasgow and Clyde'}, 'officialTitle': 'Negative Pressure Dressings Versus Non-negative Pressure Dressing for Wound Care Following Soft Tissue Sarcoma Excision', 'orgStudyIdInfo': {'id': 'GN15OR558'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Negative Pressure Wound Therapy', 'description': "120 hours of negative pressure wound therapy (ActiVAC, KCI) applied to a primarily closed ('acute') wound.", 'interventionNames': ['Device: Negative Pressure Wound Therapy (ActivVAC, KCI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard dressings', 'description': 'Absorbant dressings applied in a standard fashion, i.e. only changed as necessary', 'interventionNames': ['Device: Standard dressings']}], 'interventions': [{'name': 'Negative Pressure Wound Therapy (ActivVAC, KCI)', 'type': 'DEVICE', 'armGroupLabels': ['Negative Pressure Wound Therapy']}, {'name': 'Standard dressings', 'type': 'DEVICE', 'description': "Current absorbent dressing is 'tegaderm with absorbent pad' (3M)", 'armGroupLabels': ['Standard dressings']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G31 2ER', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Glasgow Royal Infirmary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Sanjay Gupta, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NHS Greater Glasgow and Clyde'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NHS Greater Glasgow and Clyde', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}