Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT00829556
Status:
COMPLETED
Last Update Posted:
2009-12-21
First Post:
2009-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing Total Joint Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-18', 'studyFirstSubmitDate': '2009-01-26', 'studyFirstSubmitQcDate': '2009-01-26', 'lastUpdatePostDateStruct': {'date': '2009-12-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint of the study will be to determine the incidence of postoperative wound drainage during hospital stay when adding Integuseal to the normal surgical skin preparation.', 'timeFrame': 'Total joint replacement to discharge from hospital'}], 'secondaryOutcomes': [{'measure': 'To evaluate the effect of using Integuseal on the length of hospital stay after THA or TKA.', 'timeFrame': 'Total joint replacement to discharge from hospital'}, {'measure': 'To evaluate the effect of using Integuseal on the incidence of surgical site infection (SSI).', 'timeFrame': '6 weeks'}, {'measure': 'To evaluate the effect of using Integuseal on the incidence of revision or re-admission after undergoing THA or TKA', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prosthetic Joint Infection', 'Surgical Skin Infection']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to investigate the potential benefits of using a special type of fluid that can be applied to the skin (Integuseal) in addition to standard surgical skin preparation in patients undergoing total hip replacement (THA) or total knee replacement (TKA). Integuseal is supposed to lock down the skin bacteria and reduce skin infection and other problems. This study will investigate whether Integuseal is effective in reducing persistent wound drainage when used in addition to standard surgical skin preparation for total hip arthroplasty (THA) or total knee replacement (TKA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects who are able and willing to provide informed consent;\n2. Male and non-pregnant, non-lactating, female subjects who are willing to practice effective means of contraception or postmenopausal/surgically sterilized female subjects, between the ages of 18-80 years old, of any ethnic origin.\n3. Subjects deemed able to comply with study schedule visits, procedures and medications as specified by the protocol.\n4. Subjects undergoing elective THA or TKA procedures.\n5. Subjects in satisfactory health as determined by the investigator on the basis of medical history and physical examination.\n\nExclusion Criteria:\n\n1. Subjects undergoing revision, hemiarthroplasty, or bilateral THA or TKA\n2. Subjects undergoing non-elective THA or TKA procedures.\n3. Pregnant or lactating females or females of childbearing potential not practicing an effective method of contraception.\n4. Subjects with known allergies to iodine and/or chlorhexidine'}, 'identificationModule': {'nctId': 'NCT00829556', 'briefTitle': 'Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing Total Joint Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'Single-Center, Randomized Trial to Study the Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing', 'orgStudyIdInfo': {'id': 'RIFJPAR 08-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Device: Integuseal']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Standard Surgical skin preparation'}], 'interventions': [{'name': 'Integuseal', 'type': 'DEVICE', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Javad Parvizi, MD, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rothman Institute Orthopaedics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kimberly-Clark Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Javad Parvizi, MD, FRCS', 'oldOrganization': 'Rothman Institute Orthopaedics'}}}}