Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-03-17 @ 11:35 PM
Study NCT ID:
NCT00866268
Status:
COMPLETED
Last Update Posted:
2009-03-20
First Post:
2009-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-19', 'studyFirstSubmitDate': '2009-03-19', 'studyFirstSubmitQcDate': '2009-03-19', 'lastUpdatePostDateStruct': {'date': '2009-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total post-surgical blood loss (mL)', 'timeFrame': 'from the moment after surgery until drainage catheter removal'}], 'secondaryOutcomes': [{'measure': 'blood loss (mL) in the recovery unit', 'timeFrame': '24-48 h'}, {'measure': 'Blood loss in the ward', 'timeFrame': '5-10 days'}, {'measure': "need for a blood transfusion according to the surgeon's criteria", 'timeFrame': '10 days'}, {'measure': 'number of blood units required for transfusion', 'timeFrame': '10 Days'}, {'measure': 'post-surgical pain (using a 100mm visual analogue scale)', 'timeFrame': '10 days'}, {'measure': 'incidence of hematomas', 'timeFrame': '10 days'}, {'measure': 'infections', 'timeFrame': '10 days'}, {'measure': 'suture dehiscence', 'timeFrame': '10 days'}, {'measure': 're-intervention due to complications in the surgical wound', 'timeFrame': '10 dasy'}, {'measure': 'venous thrombosis', 'timeFrame': '10 days'}, {'measure': 'hypotension', 'timeFrame': '10 days'}, {'measure': 'mortality', 'timeFrame': '10 days'}, {'measure': 'adverse reactions', 'timeFrame': '10 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Blood loss', 'Total knee arthroplasty', 'Adults', 'Drain', 'Drainage system'], 'conditions': ['Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Principal hypothesis:\n\nA low suction drainage (-50 mmHg) reduce a 25% the blood loss with respect a standard closed drainage (-700 mmHg) following total knee arthroplasty.', 'detailedDescription': "Secondary's hypothesis:\n\n* It don't expect differences in:\n\n 1. Incidence of hematomas\n 2. Incidence in surgery wound infection\n 3. Time of immobilization\n 4. Duration of hospitalization\n* The low suction drainage (-50 mmHg) will be more cost-effective than the standard closed drainage (-700 mmHg)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult knee replacement patients who agreed to participate in the study\n\nExclusion Criteria:\n\n* People that not accomplished the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT00866268', 'briefTitle': 'Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': '"Low Versus High Pressure Suction Drainage After Total Knee Arthroplasty: a Double Blind Randomized Controlled Trial"', 'orgStudyIdInfo': {'id': 'DRENAJE50MMHG/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low suction drainage', 'description': "In the experimental group the drainage catheter was connected to a modified DRENOFAST® system. This system consisted of a sterile plastic bottle with a holding capacity of 600 mL of fluid and a negative pressure of 700mmHg. It was hermetically closed and had two connections. The DRENOFAST® modification consisted of establishing an open connection between the bottle and a wall vacuum source (normally used to administer oxygen) placed next to the patient's bed. The 50 mmHg constant negative pressure of the bottle was maintained by the wall vacuum source and verified by flow meter.", 'interventionNames': ['Device: low pressure suction drainage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High suction drainage', 'description': 'The standard DRENOFAST® system was used in the control group, and the initial negative pressure was 700 mmHg.', 'interventionNames': ['Device: High pressure suction drainage']}], 'interventions': [{'name': 'low pressure suction drainage', 'type': 'DEVICE', 'otherNames': ['DRENOFAST® modified'], 'description': "In the experimental group the drainage catheter was connected to a modified DRENOFAST® system. This system consisted of a sterile plastic bottle with a holding capacity of 600 mL of fluid and a negative pressure of 700mmHg. It was hermetically closed and had two connections. The DRENOFAST® modification consisted of establishing an open connection between the bottle and a wall vacuum source (normally used to administer oxygen) placed next to the patient's bed. The 50 mmHg constant negative pressure of the bottle was maintained by the wall vacuum source and verified by flow meter. Duration: Drains were removed after bleeding had ceased (48-72h).", 'armGroupLabels': ['Low suction drainage']}, {'name': 'High pressure suction drainage', 'type': 'DEVICE', 'otherNames': ['DRENOFAST® system'], 'description': 'In order to mask the type of intervention from the patient and the investigators, both drainage systems had two drain catheters. One catheter allowed the blood to flow from the wound to the bottle. The second catheter connected the bottle to the vacuum source. In the experimental arm the second catheter was open, while in the control group it was closed. So that the system used could not be distinguished, the connection of the second catheter to the bottle was covered with opaque adhesive tape.Drains were removed after bleeding had ceased.', 'armGroupLabels': ['High suction drainage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08025', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Orthopedic and Traumatology Service. Hospital de la Santa Creu i Sant Pau.', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Calvo Rafael, Rn', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Rafa Calvo Oyón', 'oldOrganization': 'Hospital de la Santa Creu i Sant Pau'}}}}