[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486574":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":31,"locations":37,"responsibleParty":499,"collaborators":502,"id":506,"slug":507,"hasResults":508,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":508,"sex":514,"minAge":515,"maxAge":25,"enrollmentInfo":516,"targetDuration":25,"studyType":519,"phases":520,"briefSummary":522,"conditions":523,"keywords":25,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":534},{"fullName":5,"class":6},"University of Maryland, Baltimore","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Antibiotic Cement Bead Pouch","EXPERIMENTAL","The antibiotic cement bead pouch involves placing temporary non-absorbable antibiotic-laden cement beads into the open fracture wound and sealing the wound with a large occlusive dressing for prophylaxis against bacteria.\n\nThe antibiotic beads used will be prepared intraoperatively by the surgical team. The bead recipe will be comprised of a ratio of 2 grams of vancomycin, 2.4 grams of tobramycin, and 40g (one bag) of PMMA cement. The beads will be handmade and approximately 10-mm in diameter. The number of beads placed in the wound will be at the discretion of the treating surgeon based on recipient wound size. As commonly practiced, the antibiotic beads may be exchanged for new beads at each subsequent irrigation and debridement surgery. The number of beads, the number of replaced beads, and the removal of the antibiotic beads will be recorded.",[13],"Drug: Antibiotic Cement Bead Pouch",{"label":15,"type":16,"description":17,"interventionNames":18},"Negative Pressure Wound Therapy (NPWT)","ACTIVE_COMPARATOR","The NPWT system is a sealed dressing placed over the open fracture wound that includes an occlusive plastic wound dressing connected to a vacuum pump, tubing, and a canister to collect fluid. The pump creates a vacuum seal and exerts negative pressure on the wound to remove fluid and maintain a sealed environment. NPWT promotes wound healing through four primary mechanisms: 1) wound shrinkage or macrodeformation; 2) microdeformation at the foam-wound surface interface; 3) fluid removal; and 4) stabilization of the wound environment.\n\n125 mmHg continuous negative pressure is the recommended NPWT device setting; however, the treating surgeon will be allowed to adjust these settings as clinically necessary.\n\nThe frequency and timing of NPWT changes will also be at the surgeon's discretion but is expected to primarily coincide with the timing of repeat debridement, typically every 24-72 hours until definitive management has occurred.",[19],"Device: Negative Pressure Wound Therapy",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","The antibiotic bead pouch provides an antibiotic delivery mechanism. It is made by combining polymethyl methacrylate (PMMA) cement with generic forms of vancomycin and tobramycin powder.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DEVICE","Negative Pressure Wound Therapy","Standard application of negative pressure wound therapy",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Heather Phipps, MPS","CONTACT","410-706-2492","hphipps@som.umaryland.edu",[38,57,71,86,98,109,123,138,151,163,176,192,204,219,232,245,256,269,284,297,308,323,335,350,365,377,392,405,418,428,443,457,470,484],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Dignity Health Chandler Regional Medical Center","RECRUITING","Chandler","Arizona","85224","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-111.84125,33.30616,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":25,"email":56},"William Naylor, DO","(480) 728-4470","william.naylor2@commonspirit.org",{"facility":58,"status":40,"city":59,"state":42,"zip":60,"country":44,"countryCode":45,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"University of Arizona","Tucson","85721",{"type":47,"coordinates":62},[63,64],-110.92648,32.22174,{"lat":64,"lon":63},[67],{"name":68,"role":34,"phone":69,"phoneExt":25,"email":70},"Michael McKee, MD","602-827-2905","michael.mckee@bannerhealth.com",{"facility":72,"status":40,"city":73,"state":74,"zip":75,"country":44,"countryCode":45,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"University of California, Davis","Davis","California","95616",{"type":47,"coordinates":77},[78,79],-121.74052,38.54491,{"lat":79,"lon":78},[82],{"name":83,"role":34,"phone":84,"phoneExt":25,"email":85},"Augustine Saiz, MD","800-282-3284","amsaiz@health.ucdavis.edu",{"facility":87,"status":40,"city":88,"state":74,"zip":89,"country":44,"countryCode":45,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"University of Southern California","Los Angeles","90033",{"type":47,"coordinates":91},[92,93],-118.24368,34.05223,{"lat":93,"lon":92},[96],{"name":97,"role":34,"phone":25,"phoneExt":25,"email":25},"Joseph Patterson, MD",{"facility":99,"status":40,"city":88,"state":74,"zip":100,"country":44,"countryCode":45,"cosmosGeoPoint":101,"geoPoint":103,"contacts":104},"Cedars-Sinai Medical Center","90048",{"type":47,"coordinates":102},[92,93],{"lat":93,"lon":92},[105],{"name":106,"role":34,"phone":107,"phoneExt":25,"email":108},"Carol Lin, MD","310-423-9839","carol.lin@cshs.org",{"facility":110,"status":40,"city":111,"state":74,"zip":112,"country":44,"countryCode":45,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"University of California, Irvine","Orange","92868",{"type":47,"coordinates":114},[115,116],-117.85311,33.78779,{"lat":116,"lon":115},[119],{"name":120,"role":34,"phone":121,"phoneExt":25,"email":122},"Gerard Slobogean, MD","714-456-1699","gsloboge@hs.uci.edu",{"facility":124,"status":40,"city":125,"state":126,"zip":127,"country":44,"countryCode":45,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Yale University","New Haven","Connecticut","06520",{"type":47,"coordinates":129},[130,131],-72.92816,41.30815,{"lat":131,"lon":130},[134],{"name":135,"role":34,"phone":136,"phoneExt":25,"email":137},"Matthew Riedel, MD","203-785-2579","matthew.riedel@yale.edu",{"facility":139,"status":40,"city":140,"state":141,"zip":142,"country":44,"countryCode":45,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"University of Florida","Gainesville","Florida","32611",{"type":47,"coordinates":144},[145,146],-82.32483,29.65163,{"lat":146,"lon":145},[149],{"name":150,"role":34,"phone":25,"phoneExt":25,"email":25},"Jennifer Hagen, MD",{"facility":152,"status":40,"city":153,"state":141,"zip":154,"country":44,"countryCode":45,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"University of Miami","Miami","33146",{"type":47,"coordinates":156},[157,158],-80.19366,25.77427,{"lat":158,"lon":157},[161],{"name":162,"role":34,"phone":25,"phoneExt":25,"email":25},"Marilyn Heng, MD",{"facility":164,"status":40,"city":165,"state":166,"zip":167,"country":44,"countryCode":45,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Indiana University","Indianapolis","Indiana","46202",{"type":47,"coordinates":169},[170,171],-86.15804,39.76838,{"lat":171,"lon":170},[174],{"name":175,"role":34,"phone":25,"phoneExt":25,"email":25},"Yohan Jang, MD",{"facility":177,"status":40,"city":178,"state":179,"zip":180,"country":44,"countryCode":45,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"University of Maryland, R Adams Cowley Shock Trauma Center","Baltimore","Maryland","21201",{"type":47,"coordinates":182},[183,184],-76.61219,39.29038,{"lat":184,"lon":183},[187,189],{"name":188,"role":34,"phone":35,"phoneExt":25,"email":25},"Heather Phipps",{"name":190,"role":191,"phone":25,"phoneExt":25,"email":25},"Mark Gage, MD","PRINCIPAL_INVESTIGATOR",{"facility":193,"status":40,"city":194,"state":179,"zip":195,"country":44,"countryCode":45,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"University of Maryland Capital Region Health","Largo","20774",{"type":47,"coordinates":197},[198,199],-76.83025,38.89761,{"lat":199,"lon":198},[202],{"name":203,"role":34,"phone":25,"phoneExt":25,"email":25},"Todd Jaeblon, MD",{"facility":205,"status":40,"city":206,"state":207,"zip":208,"country":44,"countryCode":45,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Beth Israel Deaconess Medical Center","Boston","Massachusetts","02215",{"type":47,"coordinates":210},[211,212],-71.05977,42.35843,{"lat":212,"lon":211},[215],{"name":216,"role":34,"phone":217,"phoneExt":25,"email":218},"John Wixted, MD","(617) 667-3940","jwixted@bidmc.harvard.edu",{"facility":220,"status":40,"city":221,"state":222,"zip":223,"country":44,"countryCode":45,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"University of Mississippi","University","Mississippi","38677",{"type":47,"coordinates":225},[226,227],-89.52536,34.36594,{"lat":227,"lon":226},[230],{"name":231,"role":34,"phone":25,"phoneExt":25,"email":25},"Patrick Bergin, MD",{"facility":233,"status":40,"city":234,"state":235,"zip":236,"country":44,"countryCode":45,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Bryan Medical Center","Lincoln","Nebraska","68506",{"type":47,"coordinates":238},[239,240],-96.66696,40.8,{"lat":240,"lon":239},[243],{"name":244,"role":34,"phone":25,"phoneExt":25,"email":25},"Steven Shannon, MD",{"facility":246,"status":247,"city":248,"state":249,"zip":250,"country":44,"countryCode":45,"cosmosGeoPoint":251,"geoPoint":255,"contacts":25},"University Medical Center of Southern Nevada","WITHDRAWN","Las Vegas","Nevada","89102",{"type":47,"coordinates":252},[253,254],-115.13722,36.17497,{"lat":254,"lon":253},{"facility":257,"status":40,"city":258,"state":259,"zip":260,"country":44,"countryCode":45,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"Dartmouth-Hitchcock Medical Center","Lebanon","New Hampshire","03766",{"type":47,"coordinates":262},[263,264],-72.25176,43.64229,{"lat":264,"lon":263},[267],{"name":268,"role":34,"phone":25,"phoneExt":25,"email":25},"Ida L Gitajn, MD",{"facility":270,"status":40,"city":271,"state":272,"zip":273,"country":44,"countryCode":45,"cosmosGeoPoint":274,"geoPoint":278,"contacts":279},"Sanford Medical Center","Fargo","North Dakota","58103",{"type":47,"coordinates":275},[276,277],-96.7898,46.87719,{"lat":277,"lon":276},[280],{"name":281,"role":34,"phone":282,"phoneExt":25,"email":283},"Michael White, MD","(701) 234-2000","Michael.white@sanfordhealth.org",{"facility":285,"status":40,"city":286,"state":287,"zip":288,"country":44,"countryCode":45,"cosmosGeoPoint":289,"geoPoint":293,"contacts":294},"University of Cincinnati","Cincinnati","Ohio","45219",{"type":47,"coordinates":290},[291,292],-84.51439,39.12711,{"lat":292,"lon":291},[295],{"name":296,"role":34,"phone":25,"phoneExt":25,"email":25},"Michael Beltran, MD",{"facility":298,"status":40,"city":286,"state":287,"zip":299,"country":44,"countryCode":45,"cosmosGeoPoint":300,"geoPoint":302,"contacts":303},"Bon Secours Mercy Health","45237",{"type":47,"coordinates":301},[291,292],{"lat":292,"lon":291},[304],{"name":305,"role":34,"phone":306,"phoneExt":25,"email":307},"John Gentile, MD","330-480-3990","jgentile@mercy.com",{"facility":309,"status":40,"city":310,"state":311,"zip":312,"country":44,"countryCode":45,"cosmosGeoPoint":313,"geoPoint":317,"contacts":318},"Slocum Center","Eugene","Oregon","97401",{"type":47,"coordinates":314},[315,316],-123.08675,44.05207,{"lat":316,"lon":315},[319],{"name":320,"role":34,"phone":321,"phoneExt":25,"email":322},"Brandon Wilkinson, MD","541-485-8111","brandon.wilkinson@slocumcenter.com",{"facility":324,"status":40,"city":325,"state":311,"zip":326,"country":44,"countryCode":45,"cosmosGeoPoint":327,"geoPoint":331,"contacts":332},"Ortegon Health & Science University","Portland","97239",{"type":47,"coordinates":328},[329,330],-122.67621,45.52345,{"lat":330,"lon":329},[333],{"name":334,"role":34,"phone":25,"phoneExt":25,"email":25},"Zachary Working, MD",{"facility":336,"status":40,"city":337,"state":338,"zip":339,"country":44,"countryCode":45,"cosmosGeoPoint":340,"geoPoint":344,"contacts":345},"St. Luke's University Health Network","Bethlehem","Pennsylvania","18015",{"type":47,"coordinates":341},[342,343],-75.37046,40.62593,{"lat":343,"lon":342},[346],{"name":347,"role":34,"phone":348,"phoneExt":25,"email":349},"Douglas Lundy, MD","(484) 526-1735","douglas.lundy@sluhn.org",{"facility":351,"status":40,"city":352,"state":353,"zip":354,"country":44,"countryCode":45,"cosmosGeoPoint":355,"geoPoint":359,"contacts":360},"Prisma Health - Midlands","Columbia","South Carolina","29203",{"type":47,"coordinates":356},[357,358],-81.03481,34.00071,{"lat":358,"lon":357},[361],{"name":362,"role":34,"phone":363,"phoneExt":25,"email":364},"Daniel Cunningham, MD","(803) 296-7846","daniel.cunningham2@prismahealth.org",{"facility":366,"status":40,"city":367,"state":353,"zip":368,"country":44,"countryCode":45,"cosmosGeoPoint":369,"geoPoint":373,"contacts":374},"Prisma Health","Greenville","29605",{"type":47,"coordinates":370},[371,372],-82.39401,34.85262,{"lat":372,"lon":371},[375],{"name":376,"role":34,"phone":25,"phoneExt":25,"email":25},"Kyle Jeray, MD",{"facility":378,"status":40,"city":379,"state":380,"zip":381,"country":44,"countryCode":45,"cosmosGeoPoint":382,"geoPoint":386,"contacts":387},"Sanford Health","Sioux Falls","South Dakota","57104",{"type":47,"coordinates":383},[384,385],-96.72796,43.54369,{"lat":385,"lon":384},[388],{"name":389,"role":34,"phone":390,"phoneExt":25,"email":391},"Robert Van Demark III, MD","605-333-1000","Rob.VanDemarkIII@SanfordHealth.org",{"facility":393,"status":40,"city":394,"state":395,"zip":396,"country":44,"countryCode":45,"cosmosGeoPoint":397,"geoPoint":401,"contacts":402},"University of Utah","Salt Lake City","Utah","84112",{"type":47,"coordinates":398},[399,400],-111.89105,40.76078,{"lat":400,"lon":399},[403],{"name":404,"role":34,"phone":25,"phoneExt":25,"email":25},"Lucas Marchand, MD",{"facility":406,"status":40,"city":407,"state":408,"zip":409,"country":44,"countryCode":45,"cosmosGeoPoint":410,"geoPoint":414,"contacts":415},"Inova Fairfax","Falls Church","Virginia","22042",{"type":47,"coordinates":411},[412,413],-77.17109,38.88233,{"lat":413,"lon":412},[416],{"name":417,"role":34,"phone":25,"phoneExt":25,"email":25},"Greg Gaski, MD",{"facility":419,"status":247,"city":420,"state":421,"zip":422,"country":44,"countryCode":45,"cosmosGeoPoint":423,"geoPoint":427,"contacts":25},"University of Wisconsin","Madison","Wisconsin","53792",{"type":47,"coordinates":424},[425,426],-89.40123,43.07305,{"lat":426,"lon":425},{"facility":429,"status":40,"city":430,"state":431,"zip":432,"country":433,"countryCode":434,"cosmosGeoPoint":435,"geoPoint":439,"contacts":440},"Royal Columbian Hospital","New Westminster","British Columbia","V3L 3W7","Canada","CA",{"type":47,"coordinates":436},[437,438],-122.91092,49.20678,{"lat":438,"lon":437},[441],{"name":442,"role":34,"phone":25,"phoneExt":25,"email":25},"Darius Viskontas, MD",{"facility":444,"status":40,"city":445,"state":431,"zip":446,"country":433,"countryCode":434,"cosmosGeoPoint":447,"geoPoint":451,"contacts":452},"University of British Columbia","Vancouver","V5Z 1M9",{"type":47,"coordinates":448},[449,450],-123.11934,49.24966,{"lat":450,"lon":449},[453],{"name":454,"role":34,"phone":455,"phoneExt":25,"email":456},"David Stockton, MD","604-875-5809","David.Stockton@vch.ca",{"facility":458,"status":40,"city":459,"state":460,"zip":461,"country":433,"countryCode":434,"cosmosGeoPoint":462,"geoPoint":466,"contacts":467},"Hamilton Health Sciences","Hamilton","Ontario","L8L 2X2",{"type":47,"coordinates":463},[464,465],-79.84963,43.25011,{"lat":465,"lon":464},[468],{"name":469,"role":34,"phone":25,"phoneExt":25,"email":25},"Jamal Al-Asiri, MD",{"facility":471,"status":40,"city":472,"state":460,"zip":473,"country":433,"countryCode":434,"cosmosGeoPoint":474,"geoPoint":478,"contacts":479},"London Health Sciences Centre","London","N6C 2R6",{"type":47,"coordinates":475},[476,477],-81.23304,42.98339,{"lat":477,"lon":476},[480],{"name":481,"role":34,"phone":482,"phoneExt":25,"email":483},"Emil Schemitsch, MD","(519) 663-3307","emil.schemitsch@lhsc.on.ca",{"facility":485,"status":40,"city":486,"state":460,"zip":487,"country":433,"countryCode":434,"cosmosGeoPoint":488,"geoPoint":492,"contacts":493},"The Ottawa Hospital","Ottawa","K1Y 4E9",{"type":47,"coordinates":489},[490,491],-75.69812,45.41117,{"lat":491,"lon":490},[494],{"name":495,"role":34,"phone":496,"phoneExt":497,"email":498},"Steven Papp, MD","613-798-5555","18131","spapp@toh.ca",{"type":191,"investigatorFullName":500,"investigatorTitle":501,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Mark Gage","Associate Professor, Department of Orthopaedics",[503,505],{"name":504,"class":6},"McMaster University",{"name":110,"class":6},"100486574","phase-3-antibiotic-cement-bead-pouch-versus-negative-pressure-wound-therapy-100486574",false,"NCT05615844","Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy","A Randomized Controlled Trial Comparing Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy for the Management of Severe Open Tibia Fracture Wounds","BeadsvsVac","The inclusion criteria are:\n\n1. Patients 18 years of age or older.\n2. Severe open tibia fracture requiring more than one irrigation and debridement procedure to treat the open fracture.\n3. Planned internal or external fixation for definitive fracture management.\n4. Formal surgical debridement within 72 hours of their injury.\n5. Will have all planned fracture care surgeries performed by a participating surgeon or delegate.\n6. Informed consent obtained.\n\nThe exclusion criteria are:\n\n1. Due to the severity of injury, the treating surgeon does not believe limb salvage \\>6 months is likely to be successful based on the emergency department or initial intraoperative assessment (prior to enrolment and randomization).\n2. Medical contraindication to antibiotic beads, including previously known allergies or sensitivities to vancomycin and\u002For tobramycin.\n3. Medical or injury contraindication to NPWT. Injury contraindications could include situations in which the NPWT could not be placed over a vascular graft or exposed neurovascular structure.\n4. Received previous surgical debridement or management of their fracture at a non-participating hospital or clinic (as applicable).\n5. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.\n6. Incarceration.\n7. Women of child-bearing potential who are pregnant or intending to become pregnant within the next 6 months.\n8. Currently enrolled in a study that does not permit co-enrollment.\n9. Unable to obtain informed consent due to language barriers.\n10. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.\n11. Prior enrollment in the trial.\n12. Other reason to exclude the patient, as approved by the Methods Center.","ALL","18 Years",{"count":517,"type":518},312,"ESTIMATED","INTERVENTIONAL",[521],"PHASE3","The Beads vs Vac trial is a multi-centre randomized controlled trial of 312 participants with a severe open tibia fracture requiring multiple irrigation and debridement surgeries. Eligible participants will be randomized to receive either an antibiotic bead pouch or negative pressure wound therapy (NPWT) for their temporary open fracture wound management. Outcomes will be assessed at 6 weeks, 3 months, and 6 months post-surgery. The primary outcome will be a composite outcome to evaluate clinical status six months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) injury-related amputation of the lower extremity, 3) unplanned reoperation to manage wound complications, infection, or delayed fracture healing, and 4) clinical fracture healing as assessed using the Functional IndeX for Trauma (FIX-IT) instrument. The secondary outcomes will independently assess the four components of the primary outcome. This is a Phase III trial.",[524],"Open tíbia Fracture","2026-04-28",{"date":527,"type":528},"2026-05-05","ACTUAL",{"date":530,"type":528},"2023-11-05",{"date":532,"type":518},"2027-10-01",{"name":5,"class":6},34]