[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646008":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":30,"studyPopulation":20,"armGroups":31,"interventions":42,"overallOfficials":48,"centralContacts":53,"locations":59,"responsibleParty":74,"collaborators":20,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":20,"eligibilityCriteria":82,"healthyVolunteers":79,"sex":83,"minAge":84,"maxAge":20,"enrollmentInfo":85,"targetDuration":20,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":98,"whyStopped":20,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Sylhet M.A.G.Osmani Medical College","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Surgical Site Infection (SSI)","Proportion of patients developing surgical site infection within 30 days postoperatively, classified according to CDC\u002FNHSN criteria as superficial incisional, deep incisional, or organ\u002Fspace SSI, assessed through structured wound examination at postoperative day 3, day 7, and day 30.","30 days postoperatively",[14,17],{"measure":15,"description":16,"timeFrame":12},"Type of Surgical Site Infection","Classification of surgical site infections occurring in each group as superficial incisional, deep incisional, or organ\u002Fspace SSI, per CDC\u002FNHSN criteria.",{"measure":18,"description":19,"timeFrame":12},"Microbiological Profile of Wound Infections","Organisms isolated from wound swab culture in patients diagnosed with surgical site infection in each group.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":24,"primaryPurpose":25,"observationalModel":20,"timePerspective":20,"maskingInfo":26},"RANDOMIZED","PARALLEL","Two parallel groups: intervention group receiving subcutaneous levofloxacin infiltration prior to skin closure, and control group receiving standard surgical management alone.","PREVENTION",{"masking":27,"maskingDescription":20,"whoMasked":28},"SINGLE",[29],"OUTCOMES_ASSESSOR","Surgical site infection (SSI) remains a major cause of postoperative morbidity following emergency laparotomy, particularly in contaminated and dirty\u002Finfected abdominal conditions, where reported incidence ranges considerably higher than in elective clean surgery. Systemic antibiotic prophylaxis alone often fails to achieve adequate local tissue concentrations at the incision site due to impaired perfusion, contributing to persistently high SSI rates in this population.\n\nThis trial evaluates subcutaneous infiltration of levofloxacin, a broad-spectrum fluoroquinolone with favorable tissue penetration, administered along the wound edges immediately prior to skin closure, as an adjunct to standard surgical and antibiotic management. The infiltration dose is calculated based on wound surface area, using a levofloxacin solution prepared at 5 mg\u002FmL concentration, with total dose kept within standard systemic dosing limits.\n\nParticipants will be followed for 30 days postoperatively, with structured wound assessments at postoperative day 3, day 7, and day 30. Wound infections will be classified according to CDC\u002FNHSN criteria as superficial incisional, deep incisional, or organ\u002Fspace SSI. Where infection is suspected, wound swabs will be sent for microbiological culture and antimicrobial sensitivity testing.\n\nThis study is investigator-initiated and will be conducted as a single-center trial within the Department of Surgery, Sylhet MAG Osmani Medical College Hospital.",[32,38],{"label":33,"type":34,"description":35,"interventionNames":36},"Levofloxacin Infiltration Group","EXPERIMENTAL","Patients undergoing emergency laparotomy for contaminated or dirty\u002Finfected abdominal conditions will receive subcutaneous infiltration of levofloxacin solution (5 mg\u002FmL) along both wound edges immediately before skin closure, in addition to standard surgical and perioperative management.",[37],"Drug: Levofloxacin",{"label":39,"type":40,"description":41,"interventionNames":20},"Standard Care Group","NO_INTERVENTION","Patients undergoing emergency laparotomy for contaminated or dirty\u002Finfected abdominal conditions will receive standard surgical management and perioperative care alone, without subcutaneous levofloxacin infiltration.",[43],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":20},"DRUG","Levofloxacin","Levofloxacin solution (5 mg\u002FmL) infiltrated subcutaneously along the wound edges at a dose calculated according to wound surface area (approximately 1 mL\u002Fcm²), not exceeding the standard maximum systemic dose, administered immediately prior to skin closure.",[33],[49],{"name":50,"affiliation":51,"role":52},"Pranto Chakroborty, MBBS","Sylhet MAG Osmani Medical College Hospital","PRINCIPAL_INVESTIGATOR",[54,58],{"name":50,"role":55,"phone":56,"phoneExt":20,"email":57},"CONTACT","+8801735303838","pranto.cby@gmail.com",{"name":51,"role":55,"phone":20,"phoneExt":20,"email":57},[60],{"facility":61,"status":20,"city":62,"state":20,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Sylhet MAG Osmani Medical College","Sylhet","3100","Bangladesh","BD",{"type":67,"coordinates":68},"Point",[69,70],91.87198,24.89904,{"lat":70,"lon":69},[73],{"name":50,"role":55,"phone":56,"phoneExt":20,"email":57},{"type":52,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Pranto Chakroborty","FCPS Part-II Trainee (Neurosurgery)","100646008","rationale-of-subcutaneous-levofloxacin-infiltration-as-an-adjunct-for-surgical-site-infection-prevention-in-emergency-laparotomy-100646008",false,"NCT07696819","Rationale of Subcutaneous Levofloxacin Infiltration as an Adjunct for Surgical Site Infection Prevention in Emergency Laparotomy","Inclusion Criteria:\n\n* Patients aged 18 years and above\n* Patients undergoing emergency laparotomy for contaminated surgical pathology\n* Patients undergoing emergency laparotomy for dirty\u002Finfected surgical pathology\n\nExclusion Criteria:\n\n* Patients with known hypersensitivity to levofloxacin or other fluoroquinolones\n* Pregnant women or lactating mothers\n* Patients with pre-existing severe renal impairment\n* Patients with pre-existing skin infection at the incision site\n* Patients requiring re-laparotomy within 48 hours","ALL","18 Years",{"count":86,"type":87},90,"ESTIMATED","INTERVENTIONAL",[90],"NA","Surgical site infection (SSI) remains a major cause of postoperative morbidity following emergency laparotomy, particularly in contaminated and dirty\u002Finfected abdominal conditions. Systemic antibiotic prophylaxis alone often fails to achieve adequate local tissue concentrations at the incision site due to impaired perfusion, contributing to persistently high SSI rates in this population.\n\nThis trial evaluates subcutaneous infiltration of levofloxacin, a broad-spectrum fluoroquinolone with favorable tissue penetration, administered along the wound edges immediately prior to skin closure, as an adjunct to standard surgical and antibiotic management.\n\nThis study is investigator-initiated and will be conducted as a single-center trial within the Department of Surgery, Sylhet MAG Osmani Medical College Hospital.",[93],"Surgical Site Infection (SSI)",[95,96,97,45],"Surgical Site Infection","Emergency Laparotomy","Subcutaneous Infiltration","NOT_YET_RECRUITING","2026-07-10",{"date":101,"type":102},"2026-07-13","ACTUAL",{"date":104,"type":87},"2026-08-01",{"date":106,"type":87},"2026-10-31",{"name":5,"class":6},1]