Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-31 @ 11:53 AM
Study NCT ID:
NCT07065734
Status:
RECRUITING
Last Update Posted:
2025-07-15
First Post:
2025-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NEgative prEssure Wound Therapy in Renal Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-07-10', 'size': 35417, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-10T11:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-07-10', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound dehiscence', 'timeFrame': 'First 90 days after surgery', 'description': 'Wound dehiscence - superficial or deep'}], 'secondaryOutcomes': [{'measure': 'Wound infection', 'timeFrame': 'First 90 days after surgery', 'description': 'ASEPSIS score - (Additional treatment, Serous discharge, Erythema, Purulen exudates, Separation of deep tissues, Isolation of bacteria, Stay in hospital score); 0-10 points; higher score = worse outcome'}, {'measure': 'Pain associated with incision', 'timeFrame': 'First 90 days after surgery', 'description': 'Visual analogue scale; score 0-10; higher score=worse outcome'}, {'measure': 'Quality of life associated with incision', 'timeFrame': 'First 90 days after surgery', 'description': 'EQ-5D questionnaire (The 5-level quality of life version 5); score 0 -100 ; highest score=better outcome'}, {'measure': 'Scar healing', 'timeFrame': 'First 90 days after surgery', 'description': 'POSAS score (The Patient and Observer Scar Assessment Scale); score 1-10; highest score=worse outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transplant complication', 'renal transplant', 'wound complication'], 'conditions': ['Transplant Complication', 'Renal Transplant', 'Wound Complication']}, 'descriptionModule': {'briefSummary': 'This is a prospective study involving patients undergoing open renal transplant. Renal transplant recipients were randomly divided into two groups: the NPWT group, which received NPWT, and the Standard group, which received standard wound dressings.', 'detailedDescription': 'This is a prospective study involving patients undergoing open renal transplant between January 2023 and August 2024. Pediatric patients, those requiring surgical reinterventions within the first 3 postoperative months, and patients allergic to NPWT components were excluded from the study. Renal transplant recipients were randomly divided into two groups: the NPWT group, which received NPWT, and the Standard group, which received standard wound dressings. NPWT (PICO by Smith \\& Nephew) was applied intraoperatively at 80 mmHg and maintained for 7 days. Wound evaluations were performed at 7, 14, 30, and 90 days post-operatively. If dehiscence was present, it was classified as either deep or superficial based on the involvement of the aponeurosis. Patients were assessed for wound infection using the ASEPSIS score, pain with a visual analogue scale, and quality of life using the EQ-5D questionnaire. Scar healing was also evaluated at 30 and 90 days post-operatively with the POSAS score'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients submitted to kidney transplant\n\nExclusion Criteria:\n\n* Pediatric patients, those requiring surgical reinterventions within the first 90 days postoperative, patients allergic to NPWT components, orthotopic transplant'}, 'identificationModule': {'nctId': 'NCT07065734', 'acronym': 'NEWER', 'briefTitle': 'NEgative prEssure Wound Therapy in Renal Transplant', 'organization': {'class': 'OTHER', 'fullName': 'Centro Hospitalar De São João, E.P.E.'}, 'officialTitle': 'NEgative prEssure Wound Therapy in Renal Transplant - NEWER Trial', 'orgStudyIdInfo': {'id': '351-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NPWT group', 'description': 'Patients who received negative pressure wound therapy', 'interventionNames': ['Device: NWPT group']}, {'type': 'NO_INTERVENTION', 'label': 'Standard group', 'description': 'Patients who received standard dressing'}], 'interventions': [{'name': 'NWPT group', 'type': 'DEVICE', 'description': 'Patients submitted to negative pressure wound therapy', 'armGroupLabels': ['NPWT group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Alberto Silva, MD', 'role': 'CONTACT', 'email': 'u016845@chsj.min-saude.pt', 'phone': '+351 225 512 100'}], 'facility': 'São João University Hospital', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'centralContacts': [{'name': 'Alberto Silva, MD', 'role': 'CONTACT', 'email': 'u016845@chsj.min-saude.pt', 'phone': '+351225512100'}], 'overallOfficials': [{'name': 'João Alturas Silva, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'São João University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD will be shared upon reasonable request after consideration from local Ethics Comission'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Hospitalar De São João, E.P.E.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade do Porto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alberto Costa Silva', 'investigatorAffiliation': 'Centro Hospitalar De São João, E.P.E.'}}}}