Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
Study NCT ID:
NCT02089568
Status:
COMPLETED
Last Update Posted:
2016-08-19
First Post:
2014-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylaxis Of Wound Infections- Antibiotics in Renal Donation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019980', 'term': 'Amoxicillin-Potassium Clavulanate Combination'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 284}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-18', 'studyFirstSubmitDate': '2014-03-14', 'studyFirstSubmitQcDate': '2014-03-14', 'lastUpdatePostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of infection after surgery', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Ultrasonic evidence of wound healing', 'timeFrame': '24 months', 'description': 'Wounds will be assessed using high resolution ultrasound to assess dermal and epidermal healing.'}, {'measure': 'Length of hospital stay', 'timeFrame': '24 months'}, {'measure': 'Readmission rates', 'timeFrame': '24 months'}, {'measure': 'Antibiotic associated side effects', 'timeFrame': '24 months', 'description': 'Including diarrhoea and allergic reactions'}, {'measure': 'Return to work and normal activities', 'timeFrame': '24 months'}, {'measure': 'Quality of life', 'timeFrame': '24 months'}, {'measure': 'Relative costs', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Living donation', 'Antibiotics', 'Laparoscopic surgery'], 'conditions': ['Infection']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to see whether antibiotics given at the start of laparoscopic kidney donation surgery prevent infection.', 'detailedDescription': 'Subjects undergoing laparoscopic donor nephrectomy will be randomised to either a single dose of intravenous co-amoxiclav or placebo prior to surgery. Outcome measures include any infections, length of stay and costs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients (over 18 years) undergoing hand-assisted laparoscopic donor nephrectomy, who have given written informed consent, will be included.\n* Patients whose first language is not English will be included; they comprise a significant part of our patient population and we will use translation services as is our normal practice.\n* Women of child-bearing age taking adequate contraception will be included.\n\nExclusion Criteria:\n\n* Patients with a known allergy to penicillin or other antibiotics.\n* Patients with MRSA colonisation.\n* Participation in another investigational study within the previous 90 days.\n* Pregnant or breast-feeding women.'}, 'identificationModule': {'nctId': 'NCT02089568', 'acronym': 'POWAR', 'briefTitle': 'Prophylaxis Of Wound Infections- Antibiotics in Renal Donation', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'Are Prophylactic Antibiotics Necessary Before Laparoscopic Living Kidney Donation? A Double Blind, Randomised, Controlled Trial.', 'orgStudyIdInfo': {'id': 'POWAR'}, 'secondaryIdInfos': [{'id': '2012-000942-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug: co-amoxiclav', 'description': 'experimental', 'interventionNames': ['Drug: Co-Amoxiclav']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'comparator', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Co-Amoxiclav', 'type': 'DRUG', 'otherNames': ['Augmentin'], 'description': 'Will receive 1.2g co-amoxiclav at induction', 'armGroupLabels': ['Drug: co-amoxiclav']}, {'name': 'Normal Saline', 'type': 'DRUG', 'description': 'Placebo - 0.9% saline', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's and St Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Nizam Mamode', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guy's and St Thomas' NHS Foundation Trust"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Transplant Surgeon', 'investigatorFullName': 'Nizam Mamode', 'investigatorAffiliation': "Guy's and St Thomas' NHS Foundation Trust"}}}}