[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"surgical-site-infection-after-major-surgery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:surgical-site-infection-after-major-surgery":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100607290","phase-4-perioperative-medicine-platform-trial-100607290",false,"NCT07186634","PeRiOperative Medicine Platform Trial","Domain-Specific Appendix: OXYGEN","PROMPT","PROMPT - Inclusion Criteria:\n\n* Adult patient (≥18 years of age at time of admission)\n* Scheduled to undergo a surgical procedure involving a skin incision, with an expected duration of at least 2 hours, and a planned overnight hospital stay of at least 1 night (including, but not limited to, cardiac surgery, orthopedic surgery, obstetric, or gynecological surgery).\n\nPROMPT - Exclusion Criteria:\n\n* ASA physical status 5 (moribund, not expected to survive with or without an operation)\n* Inability to provide informed consent\n* Previous participation in PROMPT within the prior 30 days.\n\nDSA 02 - PROMPT - Exclusion Criteria:\n\n* ASA physical status 1 or 2\n* Undergoing cardiac surgery\n* Undergoing thoracic surgery if one-lung ventilation is required\n* Currently suspected or proven infection\n* Advanced lung disease requiring home oxygen therapy\n* Previous bleomycin therapy\n* Known or suspected pregnancy","ALL","18 Years",{"count":20,"type":21},7800,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Our specific aims are to investigate whether conservative (≤30%), intermediate (50%), or liberal (80%) inspired oxygen during and immediately after surgery: Aim 1: Reduces surgical site infections (SSIs or \"wound infections\") and other healthcare-associated infections (pneumonia and sepsis). Aim 2: Reduces a pooled composite of serious postoperative complications, leading to a faster and more complete recovery after surgery, and thus increases \"days alive and at home up to 30 days after surgery\" (DAH30). Primary hypothesis: Liberal (80%) oxygen concentration delivered with anesthesia in patients undergoing major surgery reduces the incidence of SSIs after surgery compared to conservative (≤30%) or intermediate (50%) oxygen concentration. Secondary hypothesis: Hyperoxia (50-80%) delivered with anesthesia in patients undergoing major surgery increases the incidence of pulmonary and other complications after surgery compared to conservative (≤30%) oxygen concentration, resulting in fewer Days At Home (DAH). PROMPT enrolls patients undergoing elective or semi-elective surgery.",[27,28,29,30,31],"Surgical Site Infection After Major Surgery","Anaesthesia","Major Complications","Quality of Recovery (QoR-15)","Quality of Life",[33,34],"Anaesthesiology, complications, oxygen, surgery","platform trial","RECRUITING","2026-04-14",{"date":38,"type":39},"2026-04-17","ACTUAL",{"date":41,"type":39},"2026-04-06",{"date":43,"type":21},"2035-12",{"name":45,"class":46},"Monash University","OTHER",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100614108","impact-of-prontosan-wound-gel-x-on-surgical-site-infections-in-cardiac-surgery-100614108","NCT07275307","Impact of Prontosan Wound Gel X on Surgical Site Infections in Cardiac Surgery","Evaluating the Effects of Prontosan Wound Gel X on the Occurrence of Superficial Surgical Site Infections in Adult Cardiac Surgery Patients: A Single-Arm, Phase IV, Adaptive Feasibility Study","PRONTOSAN","Inclusion Criteria:\n\n* Scheduled for elective cardiac surgery requiring median sternotomy (e.g., CABG, valve surgery, aortic surgery)\n* Ability to provide informed consent\n* Independent clinical decision by the treating surgeon to apply Prontosan Wound Gel X during surgery, irrespective of study enrollment\n\nExclusion Criteria:\n\n* Urgent or emergency surgery\n* Concurrent enrollment in interventional clinical trials\n* Known hypersensitivity to components of Prontosan Wound Gel X\n* Local skin conditions or infections at the planned incision site that preclude safe use of topical antiseptic products",{"count":57,"type":21},456,"OBSERVATIONAL","This study aims to evaluate the effects of Prontosan® Wound Gel X on the incidence of superficial surgical site infections (SSI) in adult patients undergoing elective cardiac surgery with median sternotomy. The primary objective is to assess how the intraoperative application of the gel impacts the occurrence of SSIs, defined according to CDC\u002FNHSN criteria. Secondary objectives include evaluating the length of hospital stay, the incidence of unplanned re-operations, and identifying any latent clinical subgroups through clustering analysis.\n\nThe study will be conducted as a prospective, single-center, observational, post-market trial. The primary endpoint will be the incidence of SSIs during the post-operative hospitalization period, while secondary endpoints will focus on hospital stay duration, re-operation rates, and feasibility indicators such as adherence to the protocol and completeness of data collection. The study also includes an exploratory endpoint where hierarchical clustering will be used to identify clinical subgroups based on demographic, clinical, and procedural variables.\n\nUp to 456 adult patients will be enrolled, all of whom are undergoing elective cardiac surgery via median sternotomy at IRCCS Policlinico San Donato. The inclusion criteria include patients aged 18 or older, scheduled for surgery, and able to provide informed consent, with the clinical decision to use Prontosan® Wound Gel X during the surgery. Exclusion criteria involve urgent surgeries, participation in other interventional studies, known hypersensitivity to the gel components, or existing skin conditions incompatible with its use.\n\nThe study duration is estimated to be approximately 18 months, depending on patient enrollment and discharge rates. The follow-up will align with the hospital stay, from the surgery date to discharge, with no post-discharge follow-up planned. Statistical analysis will include a binomial test to compare observed SSI rates with those reported in literature, while secondary data will be analyzed descriptively. An exploratory analysis will use clustering to explore latent clinical subgroups.",[27],[62,63,64,65],"Surgical site infection","SSI","Prontosan","Surgery","NOT_YET_RECRUITING","2025-11-27",{"date":69,"type":39},"2025-12-10",{"date":71,"type":21},"2026-01-08",{"date":73,"type":21},"2027-12",{"name":75,"class":46},"IRCCS Policlinico S. Donato",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":5},"100173181","effect-of-high-dose-insulin-on-infectious-complications-following-major-surgery-100173181","NCT01528189","Effect of High Dose Insulin on Infectious Complications Following Major Surgery","Effect of Hyperinsulinemic Normoglycemic Clamp (HINC) on Infectious Complications Following Major Abdominal Surgery. A Randomized Controlled Trial.","Inclusion Criteria:\n\n* \\> 18 years old\n* elective liver, pancreatic or colorectal surgery\n* ability to give informed consent\n\nExclusion Criteria:",{"count":85,"type":21},460,[87],"NA","Despite improvements in surgical techniques and perioperative care, the high incidence of postoperative surgical site infections remains a major problem in patients undergoing major abdominal surgery (liver, pancreatic and colorectal surgery).\n\nUsing the hyperinsulinemic-normoglycemic clamp technique, i.e. continuous infusion of insulin combined with dextrose titrated to \"clamp\" blood glucose between 4 and 6 mmol\u002FL, we successfully established and preserved normoglycemia during the perioperative period. Our objective of this study is to determine if the maintenance of perioperative normoglycemia by a hyperinsulinemic normoglycemic clamp reduces the rates of incisional and space\u002F surgical site infections following abdominal surgery (liver, pancreatic and colorectal surgery).",[27],[91],"Insulin, surgery, infection","2025-05-05",{"date":94,"type":39},"2025-05-08",{"date":96,"type":39},"2018-10-05",{"date":98,"type":21},"2025-12",{"name":100,"class":46},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre"]