Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-06 @ 5:57 PM
Study NCT ID:
NCT03040960
Status:
UNKNOWN
Last Update Posted:
2017-10-11
First Post:
2017-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors for Staphylococcus Aureus Surgical Site Infections in Orthopedic and Trauma Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-10', 'studyFirstSubmitDate': '2017-01-31', 'studyFirstSubmitQcDate': '2017-01-31', 'lastUpdatePostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk factors of S. aureus surgical site infections.', 'timeFrame': 'up to 1 year following surgery', 'description': 'univariate analysis of potential risk factors. Data with p value less than 0.1 were included in a logistic regression model'}], 'secondaryOutcomes': [{'measure': 'The incidence rate trend of S. aureus SSI over the year.', 'timeFrame': 'from january 1st 2012 to april 30th 2015', 'description': 'linear regression slope test of S. aureus SSI incidence rates by years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infection', 'wound infection', 'surgical wound infection', 'Staphylococcal infections', 'wound and injuries', 'postoperative complications', 'Gram-positive bacterial infections', 'bacterial infections'], 'conditions': ['Staphylococcus Aureus', 'Surgical Wound Infection', 'Orthopedic Disorder', 'Traumatology']}, 'referencesModule': {'references': [{'pmid': '10823564', 'type': 'BACKGROUND', 'citation': 'Kalmeijer MD, van Nieuwland-Bollen E, Bogaers-Hofman D, de Baere GA. Nasal carriage of Staphylococcus aureus is a major risk factor for surgical-site infections in orthopedic surgery. Infect Control Hosp Epidemiol. 2000 May;21(5):319-23. doi: 10.1086/501763.'}, {'pmid': '24367612', 'type': 'BACKGROUND', 'citation': 'Korol E, Johnston K, Waser N, Sifakis F, Jafri HS, Lo M, Kyaw MH. A systematic review of risk factors associated with surgical site infections among surgical patients. PLoS One. 2013 Dec 18;8(12):e83743. doi: 10.1371/journal.pone.0083743. eCollection 2013.'}, {'pmid': '26720215', 'type': 'BACKGROUND', 'citation': 'Marimuthu K, Eisenring MC, Harbarth S, Troillet N. Epidemiology of Staphylococcus aureus Surgical Site Infections. Surg Infect (Larchmt). 2016 Apr;17(2):229-35. doi: 10.1089/sur.2015.055. Epub 2015 Dec 31.'}, {'pmid': '24835378', 'type': 'BACKGROUND', 'citation': 'Lepelletier D, Saliou P, Lefebvre A, Lucet JC, Grandbastien B, Bruyere F, Stahl JP, Keita-Perse O, Berthelot P, Aho S; workgroup SF2H. "Preoperative risk management: strategy for Staphylococcus aureus preoperative decolonization" (2013 update). French society of Hospital Hygiene. Med Mal Infect. 2014 Jun;44(6):261-7. doi: 10.1016/j.medmal.2014.04.003. Epub 2014 May 14. No abstract available.'}, {'pmid': '25927093', 'type': 'BACKGROUND', 'citation': 'Webster J, Osborne S. Preoperative bathing or showering with skin antiseptics to prevent surgical site infection. Cochrane Database Syst Rev. 2015 Feb 20;2015(2):CD004985. doi: 10.1002/14651858.CD004985.pub5.'}]}, 'descriptionModule': {'briefSummary': 'The most commonly identified organism for Surgical Site Infection (SSI) in orthopedic surgery is Staphylococcus aureus but risk factors for mono microbial S.aureus SSI are not well-known. The aim of this study was to evaluated the incidence rate of S. aureus SSI over the years and risk factors of these infections in a french University Hospital.', 'detailedDescription': 'Surgical site infections (SSI) in orthopedic surgery are responsible for reduced quality of life, increased length of hospital stay and costs. The most commonly identified organism is Staphylococcus aureus but risk factors for mono microbial S.aureus SSI are not well-known.The aim of this study was to evaluate the incidence rate trend of S. aureus SSI over the years and risk factors of theses infections in a french University Hospital.\n\nThe knowledge obtained by this study will enable identification of the surgical patients most at risk of developping S. aureus SSI, and who would probably benefit most from new interventions given prophylactically and specifically to prevent S. aureus infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing orthopedic or traumatologiy surgeries in Grenoble university hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* orthopedic or traumatology surgeries performed in Grenoble University Hospital,\n* from january 1st 2012 to april 30th 2015,\n* the subject is undergoing one of the following surgical procedures : knee and hip arthroplasties, osteosynthesis of proximal femur and other osteosynthesis except skull and spine.\n* the subject is 16 years of age or older\n\nExclusion Criteria:\n\n* non orthopedic or trauma surgery performed in Grenoble University Hospital,\n* spine surgeries,\n* surgeries of the hand, scaphoid and carpal bones.'}, 'identificationModule': {'nctId': 'NCT03040960', 'acronym': 'ISO', 'briefTitle': 'Risk Factors for Staphylococcus Aureus Surgical Site Infections in Orthopedic and Trauma Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Risk Factors for Staphylococcus Aureus Surgical Site Infections in Orthopedic and Trauma Surgery', 'orgStudyIdInfo': {'id': '38RC16.223'}, 'secondaryIdInfos': [{'id': '1985246', 'type': 'OTHER', 'domain': 'CNIL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Caroline Landelle', 'role': 'CONTACT', 'email': 'clandelle@chu-grenoble.fr', 'phone': '0033476765643'}], 'facility': 'University Hospital, Grenoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'centralContacts': [{'name': 'Caroline Landelle, PH', 'role': 'CONTACT', 'email': 'clandelle@chu-grenoble.fr', 'phone': '0033476765643'}], 'overallOfficials': [{'name': 'Caroline landelle, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}