Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-11 @ 3:48 PM
Study NCT ID:
NCT02664168
Status:
UNKNOWN
Last Update Posted:
2018-04-12
First Post:
2016-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO™) or Standard Care Dressings (AQUACEL® Ag SURGICAL Dressing)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'lastUpdateSubmitDate': '2018-04-10', 'studyFirstSubmitDate': '2016-01-22', 'studyFirstSubmitQcDate': '2016-01-25', 'lastUpdatePostDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Surgical Site Infection', 'timeFrame': '90 days post-op'}]}, 'conditionsModule': {'conditions': ['Surgical Wound Infection']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the prevention of incision healing complications in patients undergoing revision TKA and THA treated with either Single-Use NPWT (PICO) compared to standard of care dressings (AQUACEL Ag Surgical Dressing). All patients undergoing a revision TKA and THA who consent to taking part in the study, and meet the eligibility criteria will be included onto the study. Patients will be followed up for a period of up to 3 months to determine if there are any latent incision healing complications'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient ≥18 years old\n2. Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females\n3. Subjects undergoing revision total knee arthroplasty or revision total hip arthroplasty\n4. Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information\n5. Subjects deemed able to understand and comply with study visit schedule and procedures\n\nExclusion Criteria:\n\n1. Wounds that require daily inspection\n2. Active bleeding within the surgical site\n3. Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception\n4. Subjects on warfarin therapy. Resulting in increased exudate and prolonging hospital stay following surgery to achieve therapeutic INR levels\n5. Skin integrity issues that preclude the use of Negative Pressure Wound Therapy (NPWT)\n6. Subjects undergoing primary total joint procedures\n7. Subjects with a known history of poor compliance with medical treatment\n8. Subjects who have participated in this trial previously and who were withdrawn 9 . Subjects with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing)'}, 'identificationModule': {'nctId': 'NCT02664168', 'briefTitle': "A Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO™) or Standard Care Dressings (AQUACEL® Ag SURGICAL Dressing)", 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': "A Prospective, Randomized, Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO™) or Standard Care Dressings (AQUACEL® Ag SURGICAL Dressing)", 'orgStudyIdInfo': {'id': '2016Jpar01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aquacel Ag Surgical Dressing', 'interventionNames': ['Device: Aquacel Ag Surgical Dressing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single-Use Negative Pressure Wound Therapy (PICO)', 'interventionNames': ['Device: Single-Use Negative Pressure Wound Therapy (PICO)']}], 'interventions': [{'name': 'Aquacel Ag Surgical Dressing', 'type': 'DEVICE', 'armGroupLabels': ['Aquacel Ag Surgical Dressing']}, {'name': 'Single-Use Negative Pressure Wound Therapy (PICO)', 'type': 'DEVICE', 'armGroupLabels': ['Single-Use Negative Pressure Wound Therapy (PICO)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tiffany Morrison', 'role': 'CONTACT', 'email': 'tiffany.morrison@rothmaninstitute.com', 'phone': '267-339-7818'}], 'facility': 'Rothman Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Tiffany Morrison, MS', 'role': 'CONTACT', 'email': 'tiffany.morrison@rothmaninstitute.com', 'phone': '267-339-7818'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}