[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593309":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":28,"locations":37,"responsibleParty":62,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":20,"enrollmentInfo":77,"targetDuration":20,"studyType":80,"phases":81,"briefSummary":72,"conditions":83,"keywords":93,"overallStatus":105,"whyStopped":20,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Nitropaste","EXPERIMENTAL","All patients enrolled in this study will receive a baseline perfusion measurement with the LA-ICG system. This will occur after wound closure. Subsequently, all patients will receive a single dose of nitropaste intraoperatively and a final LA-ICG tissue perfusion measurement.",[13],"Drug: Nitroglycerin Ointment 2%",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Nitroglycerin Ointment 2%","Patients will have pre- and post-nitropaste tissue perfusion measurement with the LA-ICG system.",[9],null,[22,25],{"name":23,"affiliation":5,"role":24},"Henry T Shu, MD","STUDY_DIRECTOR",{"name":26,"affiliation":5,"role":27},"Babar Shafi, MD, MSPT","PRINCIPAL_INVESTIGATOR",[29,33],{"name":23,"role":30,"phone":31,"phoneExt":20,"email":32},"CONTACT","2408050284","hshu5@jhmi.edu",{"name":34,"role":30,"phone":35,"phoneExt":20,"email":36},"Babar Shafiq, MD, MSPT","4432877847","bshafiq2@jhmi.edu",[38,54],{"facility":39,"status":20,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"The Johns Hopkins Hospital","Baltimore","Maryland","21201","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-76.61219,39.29038,{"lat":49,"lon":48},[52],{"name":23,"role":30,"phone":53,"phoneExt":20,"email":32},"240-805-0284",{"facility":55,"status":20,"city":40,"state":41,"zip":56,"country":43,"countryCode":44,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},"Johns Hopkins Bayview Medical Center","21224",{"type":46,"coordinates":58},[48,49],{"lat":49,"lon":48},[61],{"name":23,"role":30,"phone":53,"phoneExt":20,"email":32},{"type":63,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[65],{"name":66,"class":6},"Orthopaedic Trauma Association","100593309","phase-1-enhancing-wound-perfusion-in-high-risk-lower-extremity-orthopaedic-surgery-a-study-on-nitropaste-using-intraoperative-spy-imaging-100593309",false,"NCT07004764","Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Study on Nitropaste Using Intraoperative SPY Imaging.","Enhancing Wound Perfusion in High-Risk Lower Extremity Orthopaedic Surgery: A Feasibility Study on Nitropaste Using Intraoperative SPY Imaging.","SPY NITROPASTE","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Undergoing surgery for one of the following procedures:\n\n  * Current Procedural Terminology (CPT) 28415 - Open reduction calcaneal fracture ± internal\u002Fexternal fixation\n  * CPT-27814 - Open reduction of bimalleolar fracture ± internal\u002Fexternal fixation\n  * CPT-27822 - Open reduction trimalleolar ankle fracture, medial and lateral malleoli only, ± internal\u002Fexternal fix\n  * CPT-27823 - Open reduction trimalleolar ankle fracture, including posterior malleolus, ± internal\u002Fexternal fix\n  * CPT-27826 - Open reduction pilon fracture, internal\u002Fexternal fixation of fibula ONLY\n  * CPT-27827 - Open reduction pilon fracture, internal\u002Fexternal fixation of tibia ONLY\n  * CPT-27828 - Open reduction pilon fracture, internal\u002Fexternal fixation of tibia AND fibula\n  * CPT-27535 - Open reduction unicondylar tibial plateau fracture, ± internal\u002Fexternal fixation\n  * CPT-27536 - Open reduction bicondylar tibial plateau fracture, ± internal\u002Fexternal fixation\n  * CPT-28445 - Open reduction of talus fracture, ± internal\u002Fexternal fixation\n  * CPT-27650 - Primary Achilles tendon repair\n* English-speaking\n* Able to provide informed consent during preoperative clinic visit, in the preoperative nursing area, or on inpatient units.\n\nExclusion Criteria:\n\n* Contraindications to nitroglycerin, including known allergy.\n* Allergy to indocyanine green or components of ICG dye, including allergies to iodine or shell-fish.\n* Severe kidney injury, as determined by attending surgeon and\u002For anesthesiologist, that would impair clearance of ICG dye.\n* Pregnant patients","ALL","18 Years",{"count":78,"type":79},15,"ESTIMATED","INTERVENTIONAL",[82],"PHASE1",[84,85,86,87,88,89,90,91,92],"Achilles Tendon Repairs\u002FReconstructions","Pilon Fracture of Tibia","Tibial Plateau Fracture","Ankle Fracture (Bimalleolar Equivalent, Bimalleolar, or Trimalleolar)","Calcaneus Fractures","Talus Fracture","Wound Infection Deep","Wound Infection Post-Traumatic","Wound Dehiscence, Surgical",[94,95,96,97,98,85,86,99,88,100,101,102,103,104],"Laser-assisted indocyanine green angiography","nitropaste","nitroglycerin","topical nitroglycerin","Achilles tendon repairs\u002Freconstructions","Ankle Fracture (bimalleolar equivalent, bimalleolar, or trimalleolar)","Talus fracture","Wound Dehiscence","Wound infection","tissue perfusion","Orthopaedic surgery","NOT_YET_RECRUITING","2026-03-30",{"date":108,"type":109},"2026-03-31","ACTUAL",{"date":111,"type":79},"2026-11",{"date":113,"type":79},"2027-12",{"name":5,"class":6},2]