[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-operative-surgical-site-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-operative-surgical-site-infection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100414556","phase-3-evaluation-of-a-new-strategy-for-protocolized-antibiotic-care-for-severe-open-fractures-sextant-2-100414556",false,"NCT04678154","Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2","Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2 - A Continuation of the Multicenter Randomized Control Trial SEXTANT 1","SEXTANT 2","Inclusion Criteria:\n\n1. Injury meeting at least one of the following criteria:\n\n   a. Gustilo type III fractures of the tibia (OTA 41 plateau, OTA 42 shaft and OTA 43 pilon); ankle (OTA 44); calcaneus (OTA 82) and\u002For talus (OTA 81) with injury characteristics meeting at least one of the following criteria: i. All IIIB fractures ii. IIIA fractures that require a planned second debridement prior to definitive closure \u002F coverage iii. IIIA fractures with extensive contamination or muscle damage precluding definitive internal fixation at the time of initial surgery iv. IIIA fractures with extensive degloving or wound greater than 10 cm after debridement (if indicated, primary wound closure is allowed. Primary wound closure refers to the definitive closure of the wound at the initial surgical event, without plans for re-entry for additional debridement and\u002For fracture fixation) v. IIIA fractures severe fracture comminution resulting from high energy trauma (if indicated, primary wound closure\u002Fcoverage is allowed) vi. IIIA fractures with AO\u002FOTA OFC contamination level of severe with material imbedded into bone or soft tissue or with a severe high risk environmental contamination from farm, fecal, dirty water inoculation or other equivalent (if indicated, primary wound closure\u002Fcoverage is allowed) vii. IIIA Fractures where the skin could be closed after extensive muscle or bone removal (if indicated, primary wound closure\u002Fcoverage is allowed) viii. IIIA fractures with bone loss resulting in a circumferential gap of 1 cm after debridement (if indicated, primary wound closure\u002Fcoverage is allowed) ix. Fractures where fasciotomies were performed for impending or diagnosed compartment syndromes (regardless of the initial open or closed classification of the fracture x. Traumatic \"zone-of-injury\" trans-tibial amputations requiring DPC, and\u002For flap coverage\n2. Ages 18 - 64 years inclusive\n3. Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.\n4. Patients may have a traumatic brain injury.\n5. Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur, or foot injuries.\n6. Patients may be treated initially at an outside institution prior to transferring to the study institution, as long as the definitive wound closure\u002Fcoverage was not performed prior to entrance into the study.\n7. Patients with bilateral injuries that meet inclusion criteria may be included, but only the limb rated as \"more severe\" by the treating surgeon will be enrolled in the study.\n8. Patients may have co-existing non-tibial or hindfoot infections, with or without antibiotic treatment.\n9. Patients may be definitively stabilized using any method (nail, plate, ex fix, or cast).\n10. Patients may have fasciotomy.\n\nExclusion Criteria:\n\n1. Patient speaks neither English or Spanish\n2. Patient in current therapy for a wound, implant or fracture site infection related to the study site.\n3. Patient is pregnant, potentially pregnant, or lactating.\n4. Patient likely to have difficulty maintaining follow-up, including:\n\n   1. Diagnosis of a severe psychiatric condition\n   2. Intellectually challenged without adequate family support\n   3. Resides outside of the hospital's catchment area, unless willing to follow-up by phone or telemedicine\n   4. Planning to follow-up at another medical center, unless willing to follow-up by phone or telemedicine\n   5. Being a prisoner\n   6. Not having a means of contact (address, cell phone, home phone, e-mail)","ALL","18 Years","64 Years",{"count":21,"type":22},600,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The PRCT evaluates infection outcomes as well as fracture and antibiotic-related complications to include the emergence of resistant bacteria associated with two different antibiotic strategies in the treatment of Gustilo type IIIB tibia and hindfoot fractures (calcaneus and talus) and selected IIIA fractures of the tibia and trauma-related transtibial amputations that are performed in the \"zone-of-injury\". This study will be conducted in established METRC level 1 trauma centers.\n\nThe patients will be randomized as close to admission as possible to either 1) Standard of Care (SOC) prophylactic open fracture protocol, including the use of topical antibiotic as per the usual practice of the surgeon or 2) experimental protocol (SEXTANT). The SEXTANT protocol includes application of wound bioburden-targeted topical Vancomycin powder and Tobramycin powder antibiotic treatment at the time of final wound closure\u002Fcoverage combined with 72 hours of systemic antibiotic coverage targeted to both gram-positive and gram-negative pathogens. The study will compare the results of the current SOC prophylactic coverage to the strategic wound bioburden treatment (SEXTANT) protocol.\n\nUp until the time of definitive wound closure\u002Fcoverage, all patients will be treated per the usual regimen of the surgeon \u002F center and in accordance with current Trauma Quality Improvement Program (TQIP) and Surgical Quality Improvement Program (SQIP) recommendations for the care of open fractures.14,15,17 It includes the administration of systemic antibiotics as close to the time of injury as possible.\n\nIn the definitive wound closure\u002Fcoverage procedure post-operative period, participants in the intervention arm will receive 72 hours of systemic antibiotic therapy targeted at the modern wound bioburden, and patients in the usual care arm will receive post-operative care per the usual practice of their surgeon. All other activities related to follow-up and related treatments will proceed per the usual practice of the surgeon.",[28],"Post Operative Surgical Site Infection",[30,31],"Surgical site infection risk prevention","Bacterial species type and antibacterial sensitivities","RECRUITING","2026-07-20",{"date":35,"type":36},"2026-07-22","ACTUAL",{"date":38,"type":36},"2021-05-07",{"date":40,"type":22},"2029-03-31",{"name":42,"class":43},"Major Extremity Trauma Research Consortium","OTHER",31,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":70,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":5},"100562499","prevention-of-edema-after-coronary-artery-bypass-graft-by-customized-pressure-guided-elastic-bandages-100562499","NCT06603961","Prevention of Edema After Coronary Artery Bypass Graft by Customized Pressure-guided Elastic Bandages","Efficacy of Customized Pressure-Guided Elastic Bandages in Preventing Postoperative Edema and Complications in Coronary Artery Bypass Graft (CABG) Patients: A Comparative Study of Compression Therapy and Standard Post-CABG Care.","PEACCE","Inclusion Criteria:\n\n1. All patients scheduled for elective coronary artery bypass grafting (CABG) surgery with saphenous vein harvesting from the leg at Siriraj Hospital.\n2. Patients aged 18 years and older undergoing CABG surgery with saphenous vein harvesting from the leg at Siriraj Hospital, who willingly consent to participate in the study.\n\nExclusion Criteria:\n\n1. Patients with an Ankle-brachial pressure index (ABI) \\\u003C 0.8\n2. Patients with severe leg swelling (pitting edema of grade 3 or higher) or with pre-existing or post-operative heart failure that remains uncontrolled despite diuretic therapy.\n3. Patients with occlusive peripheral arterial disease (PAD) or chronic venous insufficiency (CEAP 2s), characterized by significant venous stasis, leg pain, varicose veins, or lymphadenopathy.",true,{"count":55,"type":22},106,[57],"NA","The study aimed to assess the efficacy of customized pressure-guided elastic bandages (CPG-EB) in preventing postoperative edema and complications in Coronary Artery Bypass Graft (CABG) patients. While compression therapy, like compressive stockings, has benefits in preventing edema, concerns about affordability persist. CPG-EB provides optimal sub-bandage pressure, proven effective in venous leg ulcers. Implementing CPG-EB post-CABG could enhance venous blood flow, reducing complications and improving outcomes. Patients were divided into two groups: one with CPG-EB and the other standard post-CABG care. Data collected at 1, 2, and 6 weeks post-surgery assessed swelling and wound complications. Comparative analysis used standardized criteria.",[60,61,62,63,64,65,66,67,68,69,28],"Limb Edema","Surgical Site Infections","Leg Swelling","Compression Bandages","Coronary Artery Bypass Graft","CABG","Saphenectomy","Saphenous Vein","Delayed Wound Healing","Post Operative Complications",[71,72,73,65,74],"compression bandages","compression therapy","customized pressure-guided elastic bandages","coronary arterial bypass graft","2026-02-06",{"date":77,"type":36},"2026-02-09",{"date":79,"type":36},"2025-01-19",{"date":81,"type":22},"2026-05-31",{"name":83,"class":43},"Siriraj Hospital"]