Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT02996656
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2016-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002437', 'term': 'Cefazolin'}, {'id': 'D002443', 'term': 'Ceftriaxone'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'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': 'D002439', 'term': 'Cefotaxime'}, {'id': 'D002505', 'term': 'Cephacetrile'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2016-11-25', 'studyFirstSubmitQcDate': '2016-12-14', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Biopsy', 'timeFrame': 'At the initial surgery', 'description': 'Number of bacteria identified in five skin biopsies taken at the surgical site'}], 'secondaryOutcomes': [{'measure': 'MRSA observance', 'timeFrame': '1 year following the surgery', 'description': 'Observe the patients from de MRSA group which will be receiving Vancomycin as prophylactic antibiotics.'}, {'measure': 'Infection', 'timeFrame': '1 year following the surgery', 'description': 'Assessing the appearance of C Difficile infection at 1 year post-op'}, {'measure': 'Infection #2', 'timeFrame': '1 year following the surgery', 'description': 'Assessing the appearance of resistant pathogens colonization (MRSA, VRE, Multiresistant Gram negative Bacillus) 1 year post-op'}, {'measure': 'Infection #3', 'timeFrame': '1 year following the surgery', 'description': 'Follow all the participants for one year to observe superficial tissue infection (as defined by the infection prevention team of Montreal Sacre-Coeur Hospital'}, {'measure': 'Infection #4', 'timeFrame': '1 year following the surgery', 'description': 'Follow all the participants for one year to observe deep tissue infection (as defined by the infection prevention team of Montreal Sacre-Coeur Hospital)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Propionibacterium Infection']}, 'descriptionModule': {'briefSummary': 'INESS Antibiotic Prophylaxis in Orthopedic Guide recommends the use of Cefazolin at induction for all orthopaedic procedure with implantation of internal fixation device. With the increasing rate of identified P. acnes shoulder surgery infection despite the use of recommended skin preparation and preoperative prophylactic antibiotics, a question arises; Is Cefazolin the most effective prophylactic antibiotic for shoulder surgery? The objective of this study is to determine if Ceftriaxone is superior to Cefazolin as a prophylactic antibiotic for skin colonization with P. acnes in primary shoulder surgery', 'detailedDescription': 'This is a double blinded randomized clinical trial comparing two different prophylactic antibiotics used for primary open shoulder surgery. The participants are volunteer patients scheduled for a primary open elective or trauma shoulder surgery. Patients with positive MRSA screening test will be excluded from the randomised study as they will receive vancomycin for prophylaxis. If they accept to participate, they will be included in the observational MRSA+ arm. The investigators will take from the participants the same data as the randomised patients and the investigators will take biopsies.\n\n4 equals group will be form: Female-elective: 22 envelops, 11 cefazolin, 11 ceftriaxone in a randomly order Female-trauma: 22 envelops, 11 cefazolin, 11 ceftriaxone in a randomly order Male-elective: 22 envelops, 11 cefazolin, 11 ceftriaxone in a randomly order Male-trauma: 22 envelops, 11 cefazolin, 11 ceftriaxone in a randomly order The surgeons, anesthesiologist, patients and laboratory technician, microbiologist will be blinded to the antibiotics received by the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* Male or female\n* Presenting normal skin on the shoulder aria\n\nExclusion Criteria:\n\n* Used antibiotics or treated their skin with antibiotic gel, alcohol gel or cream or acne treatment in the last three months\n* Active infection at the surgical site or anywhere\n* Affected shoulder previously received radiotherapy\n* Allergic to one of the antimicrobial prophylaxis used\n* Open fracture\n* Life threatening or a limb threatening pathology\n* Liver or kidney failure'}, 'identificationModule': {'nctId': 'NCT02996656', 'acronym': 'PAPA', 'briefTitle': 'Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Université de Montréal'}, 'officialTitle': 'Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery: A Double Blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'PAPA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cefazolin', 'description': 'During an open shoulder surgery, the Cefazolin will be administered to some patient. The Cefazolin is a first generation cephalosporin. It is a beta lactam which targets gram positive cocci and some gram negative bacilli. The INESS Antibiotic Prophylaxis in Orthopedic Guide recommends the use of Cefazolin at induction for all orthopaedic procedure with implantation of internal fixation device. The dosage is 2g intravenous if the patient weights less than 120kg or 3g if the patient weights more than 120kg. The dose should be repeated if the procedure lasts for more than three hours or if the blood loss is greater than 1500mL.', 'interventionNames': ['Drug: Cefazolin']}, {'type': 'EXPERIMENTAL', 'label': 'Ceftriaxone', 'description': 'During an open shoulder surgery, the Ceftriaxone will be administered to some patient. The Ceftriaxone is a third generation cephalosporin. It targets gram positive cocci such as staphylococcus and streptococcus, gram negative bacilli and some anaerobes, including P. acnes. The prophylactic dose is of 2g IV given a minimum of 30 minutes prior to skin incision. It is effective 12h so no other dose is needed during surgery.', 'interventionNames': ['Drug: Ceftriaxone']}], 'interventions': [{'name': 'Cefazolin', 'type': 'DRUG', 'description': 'Antibiotic that will be give before a Trauma or elective open shoulder surgery', 'armGroupLabels': ['Cefazolin']}, {'name': 'Ceftriaxone', 'type': 'DRUG', 'description': 'Antibiotic that will be give before a Trauma or elective open shoulder surgery', 'armGroupLabels': ['Ceftriaxone']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Dominique Rouleau', 'role': 'CONTACT', 'email': 'dominique_rouleau@yahoo.ca', 'phone': '514-338-2222', 'phoneExt': '2050'}, {'name': 'Karine Tardif', 'role': 'CONTACT', 'email': 'karinetardif2@gmail.com', 'phone': '514-338-2222', 'phoneExt': '3465'}], 'facility': 'Hôpital du Sacré-Cœur de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Dominique Rouleau, MD', 'role': 'CONTACT', 'email': 'dominique_rouleau@yahoo.ca', 'phone': '514-338-2222', 'phoneExt': '3427'}, {'name': 'Karine Tardif', 'role': 'CONTACT', 'email': 'karinetardif2@gmail.com', 'phone': '514-338-2222', 'phoneExt': '3465'}], 'overallOfficials': [{'name': 'Dominique Rouleau, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Montréal'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Montréal', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stryker Trauma and Extremities', 'class': 'INDUSTRY'}, {'name': "Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopaedic surgeon', 'investigatorFullName': 'Dominique Rouleau', 'investigatorAffiliation': 'Université de Montréal'}}}}