Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT04677166
Status:
TERMINATED
Last Update Posted:
2025-06-13
First Post:
2020-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coupling Negative Pressure Wound Therapy With Instillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014456', 'term': 'Ulcer'}, {'id': 'D002056', 'term': 'Burns'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to either the treatment group (negative pressure wound therapy coupled with instillation) or the control group (standard negative pressure wound therapy). Both groups will receive four days of intervention and outcomes will be measured at day four of negative pressure wound therapy and at thirty days post-operatively.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'At the American Society of Plastic Surgeons 2024 Meeting, an abstract was presented demonstrating substantial superiority of the technology employed in the experimental arm of this study versus the control.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2020-12-17', 'studyFirstSubmitQcDate': '2020-12-17', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Skin Graft Take at Four Days Post-Operative', 'timeFrame': '4 days from intervention', 'description': 'percentage of skin graft take at time of wound vac take down (4 days post-op)'}], 'secondaryOutcomes': [{'measure': 'Percentage of Skin Graft Take at Thirty Days Post-Operative', 'timeFrame': '30 days from intervention', 'description': 'percentage of skin graft take at follow up clinic appointment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Wound', 'Ulcer', 'Burns']}, 'referencesModule': {'references': [{'pmid': '29292216', 'type': 'BACKGROUND', 'citation': 'Yin Y, Zhang R, Li S, Guo J, Hou Z, Zhang Y. Negative-pressure therapy versus conventional therapy on split-thickness skin graft: A systematic review and meta-analysis. Int J Surg. 2018 Feb;50:43-48. doi: 10.1016/j.ijsu.2017.12.020. Epub 2017 Dec 29.'}, {'pmid': '25162948', 'type': 'BACKGROUND', 'citation': "Nguyen TQ, Franczyk M, Lee JC, Greives MR, O'Connor A, Gottlieb LJ. Prospective randomized controlled trial comparing two methods of securing skin grafts using negative pressure wound therapy: vacuum-assisted closure and gauze suction. J Burn Care Res. 2015 Mar-Apr;36(2):324-8. doi: 10.1097/BCR.0000000000000089."}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare standard negative pressure wound therapy with negative pressure wound therapy coupled with instillation for optimal skin graft take. Either the V.A.C ULTA NPWT or V.A.C. VeraFlo Therapy systems with normal saline will be applied intra-operatively to split-thickness skin grafts of upper and lower extremity wounds and kept in place for a duration of four days. Following completion of four days, the skin graft with be assessed for percentage of take/adherence and will be covered with simple gauze dressings as needed.', 'detailedDescription': 'Past studies have investigated the use of NPWT for post-operative skin graft treatment and shown superior outcomes regarding graft take and need for repeat grafting when compared with standard gauze dressing. However, to date, no study has compared standard NPWT to NPWT coupled with instillation for post-operative treatment of extremity skin grafts. This study is designed as a randomized, controlled pilot study to compare treatment standard NPWT with NPWT coupled with instillation on skin graft take.\n\nPatients will be selected based on inclusion criteria and randomized to either the treatment (NPWT coupled with instillation) or the control group (standard NPWT). Depending on the group to which they are randomized to, patients will have standard NPWT or NPWT coupled with instillation applied intra-operatively after application of split thickness skin graft for treatment of extremity wound.\n\nPatients randomized to control group will receive V.A.C Ulta NPWT at 125mmHg continuous pressure for duration of four days.\n\nPatients randomized to treatment group will receive V.A.C VeraFlo therapy. Protocol will consist of the following:\n\n* Instillation solution: normal saline\n* Dwell/soak time: 30 seconds\n* Cycle Time: 4 hours\n* Pressure: 125mmHg\n\nThe devices will be kept in place for four days, at which point, the wound vacs will be removed and the percentage of skin graft take will be evaluated with use of photometric analysis. The skin grafts will be subsequently dressed with gauze as appropriate. Patients will be followed up in clinic to assess outcome of skin graft take.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have been offered split-thickness skin graft for treatment of an extremity wound.\n\nExclusion Criteria:\n\n* Abnormal healing (diagnosed with connective tissue disorder)\n* Uncontrolled diabetes mellitus (HgbA1c \\>9)'}, 'identificationModule': {'nctId': 'NCT04677166', 'briefTitle': 'Coupling Negative Pressure Wound Therapy With Instillation', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Coupling Negative Pressure Wound Therapy With Instillation for Optimal Graft Take: Randomized Prospective Pilot Study', 'orgStudyIdInfo': {'id': '5200176'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NPWT with Instillation', 'description': 'NPWT coupled with instillation will be employed via use of V.A.C. VeraFlo device. The protocol to be used is as follows:\n\nInstillation Solution: normal saline Dwell/Soak Time: 30 seconds Cycle Time: 4 hours Pressure: 125mmHg', 'interventionNames': ['Device: Negative pressure wound therapy coupled with instillation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard NPWT', 'description': 'Standard NPWT with use of V.A.C. Ulta device employed at 125mmHg continuous suction.', 'interventionNames': ['Device: Standard Negative Pressure Wound Therapy']}], 'interventions': [{'name': 'Negative pressure wound therapy coupled with instillation', 'type': 'DEVICE', 'description': 'Use of V.A.C. VeraFlo to treat skin grafts with NPWT coupled with instillation.', 'armGroupLabels': ['NPWT with Instillation']}, {'name': 'Standard Negative Pressure Wound Therapy', 'type': 'DEVICE', 'description': 'standard negative pressure wound therapy via V.A.C. Ulta device at 125mmHg suction.', 'armGroupLabels': ['Standard NPWT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Subhas W Gupta, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Acelity', 'class': 'OTHER'}, {'name': 'KCI USA, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}