[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635222":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":38,"centralContacts":47,"locations":56,"responsibleParty":107,"collaborators":109,"id":112,"slug":113,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":114,"sex":120,"minAge":121,"maxAge":29,"enrollmentInfo":122,"targetDuration":29,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":133,"overallStatus":59,"whyStopped":29,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Slagelse Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Laparotomy Patient Cohort","EXPERIMENTAL","Participants undergoing emergency or elective laparotomy will be followed prospectively with standardized wound assessment, microbiological sampling, and serial point-of-care ultrasound examinations to evaluate subcutaneous fluid accumulation and development of surgical site infection.",[13,14,15,16],"Diagnostic Test: Point-of-Care Ultrasound (POCUS)","Diagnostic Test: Microbiological Wound Swab","Diagnostic Test: ASEPSIS Wound Assessment","Diagnostic Test: Standardized Wound Photography",[18,25,30,34],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DIAGNOSTIC_TEST","Point-of-Care Ultrasound (POCUS)","Three standardized postoperative ultrasound examinations performed on post-operative day 1-3, 4-6, and 7-9 to measure subcutaneous fluid collections and assess the risk of surgical site infection.",[9],[24],"Bedside Ultrasonography",{"type":19,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Microbiological Wound Swab","Single postoperative swab of the closed incision and surrounding skin obtained between POD 1-3 for microbiological assessment.",[9],null,{"type":19,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"ASEPSIS Wound Assessment","Structured wound scoring performed at each postoperative assessment to evaluate clinical signs of surgical site infection.",[9],{"type":19,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Standardized Wound Photography","Photographic documentation of the surgical incision at each postoperative assessment to support blinded evaluation.",[9],[39,43],{"name":40,"affiliation":41,"role":42},"Christian Pállson Nolsøe, MD, Ph.D","Zealand University Hospital","STUDY_CHAIR",{"name":44,"affiliation":45,"role":46},"Jakob Burcharth, MD, Ph.D","Copenhagen University Hospital at Herlev","STUDY_DIRECTOR",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":29,"email":52},"Talha Malik, MD","CONTACT","+ 45 20 58 44 06","exittm@regionsjaelland.dk",{"name":54,"role":50,"phone":29,"phoneExt":29,"email":55},"Michael Tvilling Madsen, MD, Ph.D","mitm@regionsjaelland.dk",[57,76,91],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Copenhagen University Hospital - Herlev & Gentofte","RECRUITING","Herlev","Capital Region","2730","Denmark","DK",{"type":66,"coordinates":67},"Point",[68,69],12.43998,55.72366,{"lat":69,"lon":68},[72,74],{"name":49,"role":50,"phone":73,"phoneExt":29,"email":52},"+45 20 58 44 06",{"name":44,"role":50,"phone":29,"phoneExt":29,"email":75},"Jakob.Burcharth@regionh.dk",{"facility":77,"status":59,"city":78,"state":79,"zip":80,"country":63,"countryCode":64,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Zealand University Hospital - Køge","Køge","Region Sjælland","4600",{"type":66,"coordinates":82},[83,84],12.18214,55.45802,{"lat":84,"lon":83},[87],{"name":88,"role":50,"phone":89,"phoneExt":29,"email":90},"Christian P Nolsøe, MD, Ph.D","+45 20 86 08 80","cnolsoe@cnolsoe.dk",{"facility":5,"status":59,"city":92,"state":79,"zip":93,"country":63,"countryCode":64,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Slagelse","4200",{"type":66,"coordinates":95},[96,97],11.35459,55.40276,{"lat":97,"lon":96},[100,101,103,105],{"name":49,"role":50,"phone":73,"phoneExt":29,"email":52},{"name":102,"role":50,"phone":29,"phoneExt":29,"email":55},"Michael T Madsen, MD, Ph.D",{"name":49,"role":104,"phone":29,"phoneExt":29,"email":29},"PRINCIPAL_INVESTIGATOR",{"name":54,"role":106,"phone":29,"phoneExt":29,"email":29},"SUB_INVESTIGATOR",{"type":108,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[110,111],{"name":41,"class":6},{"name":45,"class":6},"100635222","the-spotlight-study-early-identification-of-post-surgical-infections-using-bedside-ultrasound-100635222",false,"NCT07549880","The Spotlight Study: Early Identification of Post-Surgical Infections Using Bedside Ultrasound.","Post-Laparotomy Fluid Monitoring With Point of Care Ultrasonography : Predicting Surgical Site Infection & Optimizing Patient Convalescence (SPOTLIGHT Study).","SPOTLIGHT","Inclusion Criteria:\n\n* Adults \\>18 years.\n* Undergoing emergency or elective laparotomy.\n* Primary or delayed primary wound closure (DPC).\n* Wound classification: clean, clean-contaminated, contaminated, or dirty.\n* Informed consent obtained.\n\nExclusion Criteria:\n\n* Laparoscopic surgery\n* Wounds healing by secondary intention.\n* Ongoing wound dehiscence treatment with Negative Pressure Wound Therapy (NPWT).\n* Non-Danish residents","ALL","18 Years",{"count":123,"type":124},100,"ESTIMATED","INTERVENTIONAL",[127],"NA","Introduction:\n\nThe goal of this observational study is to learn whether point-of-care ultrasound (POCUS) can help detect early fluid build-up under the skin after open abdominal surgery (laparotomy) and whether these findings can predict surgical site infection. The study includes adults who recently had emergency or planned open abdominal surgery.\n\nHypothesis:\n\nThe main questions it aims to answer are:\n\n1. Does ultrasound identify subcutaneous fluid collections early after surgery?\n2. Do these fluid collections help predict which participants will develop a surgical site infection?\n\nIntervention:\n\nParticipants will:\n\n1. Have a superficial wound swab taken once at the start of the study (for research only).\n2. Receive three ultrasound scans of their surgical wound during days 1-3, 4-6, and 7-9 after surgery.\n3. Have their wound checked for redness, swelling, tenderness, or discharge before each scan.\n4. Be followed for 7 and 30 days after surgery (and up to 90 days if they have implanted mesh) to see whether an infection develops.\n\nUltrasound is non-invasive and safe. According to the protocol, \"no serious adverse effects are expected,\" though some participants may feel brief discomfort from pressure on a tender wound.\n\nThis study will help researchers understand whether routine bedside ultrasound can support earlier detection of wound infections and improve postoperative care in the future.",[130,131,132],"Surgical Site Infection (SSI)","Emergency Laparotomies","Point of Care Ultrasound (POCUS)",[134,135,136],"point of care ultrasound (POCUS)","surgical site infection (SSI)","Emergency laparotomies","2026-04-17",{"date":139,"type":140},"2026-04-24","ACTUAL",{"date":142,"type":140},"2026-04-10",{"date":144,"type":124},"2027-08-30",{"name":5,"class":6},3]