[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100387256":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":57,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":61,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":25,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"University of Florida","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","ACTIVE_COMPARATOR","VersaWrap Treatment Arm- Zone 2 flexor tendon repair with the use of VersaWrap",[13,14],"Procedure: Standard of Care Surgical Procedure","Device: VersaWrap Treatment",{"label":16,"type":10,"description":17,"interventionNames":18},"Group B","Standard of Care Treatment Arm- Zone 2 flexor tendon repair",[13],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Standard of Care Surgical Procedure","Zone 2 Flexor Tendon surgical repair will be performed by the principal investigator per standard of care. The same technique of tendon repair will be performed for all patients.",[9,16],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DEVICE","VersaWrap Treatment","is intended to manage and protect tendon injuries where there is no significant loss of tendon tissue",[9],[32],{"name":33,"affiliation":5,"role":34},"Ellen Satteson, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Stephan Alvarez","CONTACT","352-294-5687","stephan.alvarez@surgery.ufl.edu",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Gainesville","Florida","32610","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-82.32483,29.65163,{"lat":53,"lon":52},[56],{"name":33,"role":34,"phone":25,"phoneExt":25,"email":25},{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100387256","prospective-randomized-blinded-trial-of-versawrap-tendon-protector-for-zone-2-flexor-tendon-injuries-100387256",false,"NCT04322370","Prospective Randomized Blinded Trial of VersaWrap Tendon Protector for Zone 2 Flexor Tendon Injuries","Inclusion Criteria:\n\n* Adult patients presenting to the plastic surgery service with a zone 2 flexor tendon injury requiring surgical repair\n\nExclusion Criteria:\n\n* Patients with a sensitivity or allergy to polysaccharides alginate, hyaluronic acid, or citrate\n\n  * Patients with psychiatric or medical problems that preclude them from having surgery\n  * Female patients that are pregnant or breastfeeding\n  * Prisoners\n  * Patients who are unwilling or unable to follow-up","ALL","18 Years","99 Years",{"count":69,"type":70},42,"ESTIMATED","INTERVENTIONAL",[73],"NA","To analyze outcomes between patients with Z2FT injuries following repair, randomized to two groups. The first group will be the negative control, with no tendon wrap. The second group will have a VersaWrap Tendon Protector applied over the site of the tendon repair. VersaWrap is current SOC at UF.",[76],"Flexor Tendon","2025-03-12",{"date":79,"type":80},"2025-03-17","ACTUAL",{"date":82,"type":80},"2020-08-21",{"date":84,"type":70},"2027-05-17",{"name":5,"class":6},1]