Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-04 @ 3:52 PM
Study NCT ID:
NCT04039659
Status:
UNKNOWN
Last Update Posted:
2019-07-31
First Post:
2019-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
POstoperative Negative-pressure Incision Therapy Following LIver TRANSplant:a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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', 'interventionModelDescription': 'After signing the informed consent of those patients who meet the inclusion criteria, they will be randomized into two groups to install the PICOⓇ device or conventional dressings over the wound. After 7 days, the PICOⓇ device will be removed and both preoperative and postoperative variables will be studied.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2019-06-10', 'studyFirstSubmitQcDate': '2019-07-29', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence rate of surgical site', 'timeFrame': '30 days after surgery', 'description': 'Any complication of surgical site will be registered'}], 'secondaryOutcomes': [{'measure': 'Quality of life of transplantation patient', 'timeFrame': '6 months', 'description': 'We will use Cardiff Wound Impact Schedule to evaluate the possible improvement in the quality of life of transplantation patients derived from the decrease in the requirement of health resources.'}, {'measure': 'Nosocomial infection rate', 'timeFrame': '30 days after surgery (3rd, 7th, 15th and 30th post trasplant)', 'description': 'To verify the change in rates of nosocomial infections in the context of liver transplantation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wound complications', 'negative-pressure wound therapy'], 'conditions': ['Liver Transplant; Complications']}, 'referencesModule': {'references': [{'pmid': '1656747', 'type': 'BACKGROUND', 'citation': 'Culver DH, Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG, Banerjee SN, Edwards JR, Tolson JS, Henderson TS, et al. Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):152S-157S. doi: 10.1016/0002-9343(91)90361-z.'}, {'pmid': '4014116', 'type': 'BACKGROUND', 'citation': 'Haley RW, Culver DH, Morgan WM, White JW, Emori TG, Hooton TM. Identifying patients at high risk of surgical wound infection. A simple multivariate index of patient susceptibility and wound contamination. Am J Epidemiol. 1985 Feb;121(2):206-15. doi: 10.1093/oxfordjournals.aje.a113991.'}, {'pmid': '22513974', 'type': 'BACKGROUND', 'citation': 'Webster J, Scuffham P, Sherriff KL, Stankiewicz M, Chaboyer WP. Negative pressure wound therapy for skin grafts and surgical wounds healing by primary intention. Cochrane Database Syst Rev. 2012 Apr 18;(4):CD009261. doi: 10.1002/14651858.CD009261.pub2.'}, {'pmid': '22092797', 'type': 'BACKGROUND', 'citation': 'Kilpadi DV, Cunningham MR. Evaluation of closed incision management with negative pressure wound therapy (CIM): hematoma/seroma and involvement of the lymphatic system. Wound Repair Regen. 2011 Sep-Oct;19(5):588-96. doi: 10.1111/j.1524-475X.2011.00714.x.'}, {'pmid': '24741386', 'type': 'BACKGROUND', 'citation': 'Malmsjo M, Huddleston E, Martin R. Biological effects of a disposable, canisterless negative pressure wound therapy system. Eplasty. 2014 Apr 2;14:e15. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate whether the prophylactic use of a negativa pressure therapy device (PICOⓇ) on the closed wound of the liver transplant, reduces the postoperative complications of surgical wounds, compared to the use of dressings conventional postoperative', 'detailedDescription': 'Postoperative complications of surgical wounds are frequent after surgical procedures, even more in the context of liver transplantation given the necessary immunosuppression, high surgical time, high hospital stay and intensive care, politransfusions, etc. Negative pressure therapy is well established for the treatment of open wounds, its use having been recently indicated on closed surgical wounds. The evidence to justify this intervention is still limited.\n\nThe objective of our clinical trial is to evaluate whether the prophylactic use of a negative pressure therapy device (PICOⓇ) on the closed wound of the liver transplant, reduces the postoperative complications of surgical wounds, compared to the use of dressings conventional postoperative After signing the informed consent of those patients who meet the inclusion criteria, they will be randomized into two groups to install the PICOⓇ device or conventional dressings on the wound. After 7 days, the PICOⓇ device will be removed and both preoperative and postoperative variables will be studied in terms of incidence of surgical site events, stay, etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes aged between 18 and 70 years included in the waiting list for liver transplantation by the committee of the Virgen de la Arrixaca University Hospital.\n\nExclusion Criteria:\n\n* To have been rejected for liver transplantation by said committee'}, 'identificationModule': {'nctId': 'NCT04039659', 'acronym': 'PONILITRANS', 'briefTitle': 'POstoperative Negative-pressure Incision Therapy Following LIver TRANSplant:a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Virgen de la Arrixaca'}, 'officialTitle': 'POstoperative Negative-pressure Incision Therapy Following LIver TRANSplant (PONILITRANS Study): a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2019-1-6-HCUVA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patients will be cured with dressings wound everyday or before if there are complications in surgical incisions.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PICO group', 'description': 'Patients will carry the device for 7 days uninterrupted until its withdrawal.', 'interventionNames': ['Device: Negative-pressure wound therapy (PICO)']}], 'interventions': [{'name': 'Negative-pressure wound therapy (PICO)', 'type': 'DEVICE', 'description': 'After the selection of patients and the signing of the consent, patients will be randomized and the device will be placed to those who belong to the PICO group in the operating room.', 'armGroupLabels': ['PICO group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30120', 'city': 'El Palmar', 'state': 'Murcia', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Víctor López López', 'role': 'CONTACT', 'email': 'victorrelopez@gmail.com', 'phone': '+34 637519516'}, {'name': 'Ana Delegido García', 'role': 'CONTACT', 'email': 'ana.delegido.garcia@gmail.com', 'phone': '+34 686556188'}], 'facility': 'Hospital Clínico Universitario Virgen de la Arrixaca', 'geoPoint': {'lat': 37.93939, 'lon': -1.16095}}], 'centralContacts': [{'name': 'Víctor López López', 'role': 'CONTACT', 'email': 'victorrelopez@gmail.com', 'phone': '+34 637519516'}, {'name': 'Ana Delegido García', 'role': 'CONTACT', 'email': 'ana.delegido.garcia@gmail.com', 'phone': '+ 34 686556188'}], 'overallOfficials': [{'name': 'Ana Delegido García', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Virgen de la Arrixaca'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be available when the results are published.', 'ipdSharing': 'YES', 'description': "All documentation related to the study will remain stored in the Investigator's Archive, in the participating center, in the custody of the Principal Investigator until the end of it. Once the study is finished, the documentation will be indexed and will go to the general file of the center."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Virgen de la Arrixaca', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ana Delegido Garcia', 'investigatorAffiliation': 'Hospital Universitario Virgen de la Arrixaca'}}}}