[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528869":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":41,"responsibleParty":62,"collaborators":34,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":34,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":34,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":44,"whyStopped":34,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Duhok","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"control","ACTIVE_COMPARATOR","This group will receive parenteral antibiotics to prevent infection in the surgery.",[13],"Drug: Parenteral Antibacterial Agents",{"label":15,"type":16,"description":17,"interventionNames":18},"clinical trial","EXPERIMENTAL","This group will include patients who will receive parenteral antibiotics combined with vancomycin presoaked solution for the graft.",[13,19],"Drug: Parenteral Antibacterial Agents plus Vancomycin pre-soaked graft",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Parenteral Antibacterial Agents","Parenteral antibiotic (ceftriaxone) 1 g to be given in 3 doses, at induction of anesthesia, 12 hours postoperative, and 24 hours postoperative.",[15,9],[27],"Ceftriaxone sodium",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Parenteral Antibacterial Agents plus Vancomycin pre-soaked graft","in addition to the parenteral ceftriaxone intravenous injections, the ACL graft will be soaked in the vancomycin solution for 20 minutes when prepared outside the body of patient.",[15],[33],"Ceftriaxone sodium intravenously plus Vancomycin pre-soaked graft",null,[36],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Jagar O Doski","CONTACT","07504594137","jager.doski@uod.ac",[42],{"facility":43,"status":44,"city":45,"state":34,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"College of Medicine\u002FUniversity of Duhok","RECRUITING","Duhok","42001","Iraq","IQ",{"type":50,"coordinates":51},"Point",[52,53],42.9879,36.86608,{"lat":53,"lon":52},[56,60],{"name":57,"role":38,"phone":58,"phoneExt":34,"email":59},"College Duhok","+9647504502810","is@uod.ac",{"name":61,"role":38,"phone":34,"phoneExt":34,"email":59},"College OMO Duhok",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Jagar Omar Doski","Assistant Professor","100528869","parenteral-versus-combined-parenteral-with-vancomycin-soaked-graft-in-acl-reconstruction-100528869",false,"NCT06166381","Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in ACL Reconstruction","Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in Decreasing the Risk of Infection in ACL Reconstruction Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* ACL injury that interferes with life activities and\u002For sports\n\nExclusion Criteria:\n\n* Patients for revision surgery of ACL reconstruction\n* patients with inflammatory rheumatological disorders\n* Refusal to participate in the study.","ALL","20 Years","45 Years",{"count":77,"type":78},288,"ESTIMATED","INTERVENTIONAL",[81],"NA","An anterior cruciate ligament (ACL) tear is one of the knee joint's most common soft tissue injuries \\[1\\]. It is frequently injured in non-contact and some contact competition sports and even during ordinary life activities. With an annual incidence of 68.6 per 100,000 person-years, ACL tears remain a common orthopedic injury \\[2\\]. Females are two to eight times more likely to develop ACL tears in sports compared to men who play the same particular sports \\[3\\]. Most highly demanding persons and those who develop frequent instability of their knee require reconstructive surgery on the ACL to prevent early degenerative changes in their knees. This is done by completely removing the torn or ruptured ACL and replacement with a piece of tendon or ligament (graft) \\[4\\].\n\nPost-operative infection may occur in 0.14-2.6% of ACL reconstruction despite intravenous antibiotics prophylaxis \\[5,6\\]. The deep infection results in poor outcomes with pain, stiffness, arthrofibrosis, and articular cartilage degeneration \\[7,8\\]. Few studies reported improved outcomes of infection control when the autograft presoaked in vancomycin solution during the preparation process outside the body before being transferred to the knee of the patient \\[9-13\\]. Systematic reviews and meta-analysis showed that all the articles discussing the outcome of vancomycin presoaked autograft in ACL reconstruction surgery were case series, observational retrospective, prospective comparative, or case-control studies \\[14,15\\]. Randomized control trial (RCT) provides the strongest evidence among the primary research studies to confirm the effectiveness of a new method of treatment \\[16,17\\]. To date, there is no available RCT study in this field.",[84],"Infection, Bacterial",[86,87,88,89],"Anterior cruciate ligament","reconstruction","infection","vancomycin presoaked graft","2024-12-26",{"date":92,"type":93},"2024-12-30","ACTUAL",{"date":95,"type":93},"2024-01-25",{"date":97,"type":78},"2025-02",{"name":5,"class":6},1]