Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-28 @ 9:01 AM
Study NCT ID:
NCT05189392
Status:
UNKNOWN
Last Update Posted:
2022-01-12
First Post:
2021-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of PICO Compared to Opsite Post-Op Visible on Surgical Wound in Patients at High Risk of Local Complications, Undergoing Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '21 patients with visible opsite patch and 21 patients with PICO'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2025-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-29', 'studyFirstSubmitDate': '2021-12-29', 'studyFirstSubmitQcDate': '2021-12-29', 'lastUpdatePostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'By ultrasound examination at 7 +/- 1 days after hip replacement surgery, underestimating the effect of PICO compared to Opsite Post-Op Visible in the 70% reduction of post-surgical hematoma formation', 'timeFrame': '8 day', 'description': 'By ultrasound examination at 7 +/- 1 days after hip replacement surgery, underestimating the effect of PICO compared to Opsite Post-Op Visible in the 70% reduction of post-surgical hematoma formation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Evaluate Postsurgical Hematoma']}, 'descriptionModule': {'briefSummary': 'Evaluate the effect of the PICO medical device, compared to the Opsite Post-Op Visible medical device, in reducing the formation of postsurgical hematoma in the surgical wound of patients at high risk of local complications, undergoing hip arthroplasty'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 55 and 85 years inclusive,\n* Patients with BMI ≥ 30 + ASA 3 + Diabetes mellitus\n* Patients suffering from coxarthrosis candidates for hip arthroplasty surgery or revision of hip arthroplasty\n\nExclusion Criteria:\n\n* Age\\> 85 years, \\<55 years\n* Patients who are unable to understand and want.\n* Patients with severe neurological disorders or with severe disabilities.\n* Oncological patients and patients with malignant tumor at the edge of the wound\n* Patients who have undergone radiotherapy treatment\n* Patients with bleeding disorders\n* Patients on anticoagulant treatment with warfarin or NAO\n* Previously confirmed osteomyelitis\n* Patients with liver cirrhosis\n* Patients with non-enteric fistulas\n* Patients with necrotic tissue with the presence of eschar at the intervention site\n* Patients with autoimmune thrombocytopenia.'}, 'identificationModule': {'nctId': 'NCT05189392', 'acronym': 'PICO-PTA', 'briefTitle': 'Efficacy of PICO Compared to Opsite Post-Op Visible on Surgical Wound in Patients at High Risk of Local Complications, Undergoing Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}, 'officialTitle': 'Effect of PICO Compared to Opsite Post-Op Visible on Surgical Wound in Patients at High Risk of Local Complications, Undergoing Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'PICO-PTA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '21 patients with opsite visible', 'description': 'application of visible opsite plaster on the surgical wound after hip arthroplasty'}, {'type': 'EXPERIMENTAL', 'label': '21 patients with PICO', 'description': 'application of PICO on the surgical wound after hip arthroplasty', 'interventionNames': ['Device: PICO']}], 'interventions': [{'name': 'PICO', 'type': 'DEVICE', 'otherNames': ['Opsite Visible'], 'description': 'after hip arthroplasty application of visible opsite plaster on the surgical wound', 'armGroupLabels': ['21 patients with PICO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20161', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'contacts': [{'name': 'Cesare Donarini', 'role': 'CONTACT', 'email': 'cesare.donarini@grupposandonato.it', 'phone': '0248785220'}], 'facility': 'IRCCS Istituto Ortopedico Galeazzi', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Cesare Donarini', 'role': 'CONTACT', 'email': 'cesare.donarini@grupposandonato.it', 'phone': '0248785220'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}