[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535911":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":25,"centralContacts":30,"locations":37,"responsibleParty":146,"collaborators":35,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":150,"sex":156,"minAge":157,"maxAge":35,"enrollmentInfo":158,"targetDuration":35,"studyType":161,"phases":162,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":134,"whyStopped":35,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Elsan","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Experimental group","Operated patients with positive results for their pre-operative microbiological samples.",[12],"Other: This study is with minimal risk and minimal constraints due to the addition of questionnaires",{"label":14,"type":6,"description":15,"interventionNames":16},"Control group","Operated patients with negative results for their pre-operative microbiological samples.",[12],[18],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"This study is with minimal risk and minimal constraints due to the addition of questionnaires","In this study, the specific procedures compared to routine care are :\n\n* Considering the addition of questionnaires, this study will be prospective. Due to the use of bacteriological samples, it is considered as a minimal-risk research.\n* The research procedure involves a bacteriological analysis of operative elements (sutures placed during the first intervention, the product of tendon debridement, and the subacromial bursa (cleaning product)) used during the re-intervention. These usually discarded operative samples are collected for bacteriological analysis.\n* Antibiotic treatment cannot be prescribed immediately after the surgery and during the first month following this re-intervention (time for biofilm formation). As per the protocol, even a positive sample should not lead to the initiation of systematic antibiotic therapy. In the case of identification of a pathogenic microorganism, antibiotic therapy will be prescribed, leading to discontinuation of the study.",[14,9],[23,24],"Microbiological analysis of samples collected from operated patients: in the presence of UPC, it does not influence the postoperative course","No antibiotics are prescribed during the first month after the operation.",[26],{"name":27,"affiliation":28,"role":29},"Maxime ANTONI, MD","Clinique de l'Orangerie-Strasbourg","STUDY_DIRECTOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Albatoul ZAKARIA, PhD","CONTACT","0033 6 49 77 17 52",null,"zakaria@elsan.care",[38,55,68,80,93,106,119,132],{"facility":39,"status":40,"city":41,"state":35,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Hôpital privé La Châtaigneraie ELSAN","NOT_YET_RECRUITING","Beaumont","63110","France","FR",{"type":46,"coordinates":47},"Point",[48,49],3.08294,45.75165,{"lat":49,"lon":48},[52],{"name":53,"role":33,"phone":35,"phoneExt":35,"email":54},"METAIS Pierre, MD","pierremetais@mac.com",{"facility":56,"status":40,"city":57,"state":35,"zip":58,"country":43,"countryCode":44,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Hôpital privé Saint-Martin","Caen","14050",{"type":46,"coordinates":60},[61,62],-0.35912,49.18585,{"lat":62,"lon":61},[65],{"name":66,"role":33,"phone":35,"phoneExt":35,"email":67},"Franck DORDAIN, MD","fdordain@gmail.com",{"facility":69,"status":40,"city":70,"state":35,"zip":71,"country":43,"countryCode":44,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Clinique Louis Pasteur","Essey-lès-Nancy","54270",{"type":46,"coordinates":73},[74,75],6.22691,48.705,{"lat":75,"lon":74},[78],{"name":79,"role":33,"phone":35,"phoneExt":35,"email":35},"Adrien JACQUOT, MD",{"facility":81,"status":40,"city":82,"state":35,"zip":83,"country":43,"countryCode":44,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Santy-Lyon-Ramsay","Lyon","69008",{"type":46,"coordinates":85},[86,87],4.84789,45.74906,{"lat":87,"lon":86},[90],{"name":91,"role":33,"phone":35,"phoneExt":35,"email":92},"Philippe COLLOTTE, MD","docteurcollotte@gmail.com",{"facility":94,"status":40,"city":95,"state":35,"zip":96,"country":43,"countryCode":44,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Clinique d'occitanie ELSAN","Muret","31600",{"type":46,"coordinates":98},[99,100],1.32541,43.45998,{"lat":100,"lon":99},[103],{"name":104,"role":33,"phone":35,"phoneExt":35,"email":105},"Benjamin ADAMCZEWSKI, MD","benjamin.adamczewski@gmail.com",{"facility":107,"status":40,"city":108,"state":35,"zip":109,"country":43,"countryCode":44,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"ICR-Kantys","Nice","06000",{"type":46,"coordinates":111},[112,113],7.26608,43.70313,{"lat":113,"lon":112},[116],{"name":117,"role":33,"phone":35,"phoneExt":35,"email":118},"Mikaël CHELLI, MD","dr.chelli@icr-nice.com",{"facility":120,"status":40,"city":121,"state":35,"zip":122,"country":43,"countryCode":44,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Santé Atlantique ELSAN","Saint-Herblain","44800",{"type":46,"coordinates":124},[125,126],-1.651,47.21154,{"lat":126,"lon":125},[129],{"name":130,"role":33,"phone":35,"phoneExt":35,"email":131},"Yves BOUJU, MD","yves.bouju@gmail.com",{"facility":133,"status":134,"city":135,"state":35,"zip":35,"country":43,"countryCode":44,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Clinique de l'Orangerie","RECRUITING","Strasbourg",{"type":46,"coordinates":137},[138,139],7.74553,48.58392,{"lat":139,"lon":138},[142],{"name":143,"role":33,"phone":144,"phoneExt":35,"email":145},"Maxime Antony, MD","0033 6 50 35 21 12","antoni@epaule-coude-orangerie.fr",{"type":147,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100535911","unexpected-positive-cultures-in-rotator-cuff-revision-surgery-100535911",false,"NCT06257979","Unexpected Positive Cultures in Rotator Cuff Revision Surgery","Unexpected Positive Cultures in Rotator Cuff Revision Surgery: Significance and Influence on Outcomes and Tendon Healing","POCICO","Inclusion Criteria:\n\n* Patient, male or female, aged 18 or over\n* Patient requiring re- intervention for Rotator Ruff Revision Surgery for non-healing of the same tendons after a first intervention (delay \\\u003C2 years)\n* Patient requiring arthroscopy\n* Patient having had realized a MRI of the shoulder in the 6 previous months\n* Affiliate participant or beneficiary of a social security scheme\n* Participant having been informed and not having objected to the use of their data\n\nExclusion Criteria:\n\n* Patient with at least one clinical sign of infection (fever, redness)\n* Patient with a new distant rupture on a healed cuff (\\> 3 years)\n* Patient with a history of shoulder surgery other than initial Rotator Ruff Surgery\n* Patient having received antibiotic treatment in the 2 weeks preceding inclusion\n* Participant in another research\n* Participant in a period of exclusion from another research still in progress at the time of inclusion\n* Protected participant: an adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision\n* Pregnant, breastfeeding or parturient woman\n* Participant hospitalized without consent","ALL","18 Years",{"count":159,"type":160},132,"ESTIMATED","INTERVENTIONAL",[163],"NA","In the context of rotator cuff re-intervention, the impact of Unexpected Positive Cultures (UPC) is not documented, and their management has not been studied, particularly regarding indications for antibiotic therapy, which is currently not a consensus.\n\nA prospective interventional study will be implemented to compare the results of non-randomized patient samples, whether positive or negative, taken during rotator cuff re-intervention. The objective is to assess whether these samples do not affect clinical outcomes and tendon healing rates.",[166],"Rotator Cuff Repair",[168,169],"Unexpected Positive Cultures (UPC)","Revision cuff repair surgery (RCR)","2024-06-17",{"date":172,"type":173},"2024-06-18","ACTUAL",{"date":175,"type":173},"2024-02-27",{"date":177,"type":160},"2028-03-15",{"name":5,"class":6},8]