[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100080022":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":40,"locations":41,"responsibleParty":72,"collaborators":74,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":40,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":40,"enrollmentInfo":86,"targetDuration":40,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":100,"whyStopped":40,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Association of Dutch Burn Centres","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"'ceriumnitrate silversulfadiazine (flammacerium)","ACTIVE_COMPARATOR","facial burns treatment with Cerium nitrate silver sulfadiazine",[13],"Drug: ceriumnitrate silversulfadiazine (flammacerium)",{"label":15,"type":10,"description":16,"interventionNames":17},"flammazine","facial burns treatment with silver sulfadiazine",[18],"Drug: silversulfadiazine (flammazine)",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","ceriumnitrate silversulfadiazine (flammacerium)","treatment of patients with facial burns with CE-SSD",[9],[26],"CE-SSD",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"silversulfadiazine (flammazine)","treatment of patients with facial burns with SSD",[15],[32],"SSD",[34,38],{"name":35,"affiliation":36,"role":37},"Nancy van Loey, PhD","Association of Dutch Burns Centres","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":37},"Marianne K Nieuwenhuis, PhD",null,[42,54,63],{"facility":43,"status":40,"city":44,"state":40,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":40},"Red Cross Hopsital, Burns Centre","Beverwijk","1942 LE","Netherlands","NL",{"type":49,"coordinates":50},"Point",[51,52],4.65694,52.48333,{"lat":52,"lon":51},{"facility":55,"status":40,"city":56,"state":40,"zip":57,"country":46,"countryCode":47,"cosmosGeoPoint":58,"geoPoint":62,"contacts":40},"Martini Hospital, Burns centre","Groningen","9728 NZ",{"type":49,"coordinates":59},[60,61],6.56667,53.21917,{"lat":61,"lon":60},{"facility":64,"status":40,"city":65,"state":40,"zip":66,"country":46,"countryCode":47,"cosmosGeoPoint":67,"geoPoint":71,"contacts":40},"Medical Centre Rijnmond South, Burns centre","Rotterdam","3075 EA",{"type":49,"coordinates":68},[69,70],4.47917,51.9225,{"lat":70,"lon":69},{"type":73,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR",[75],{"name":76,"class":6},"Dutch Burns Foundation","100080022","phase-4-treatment-of-facial-burns-with-flammacerium-compared-to-flammazine-and-the-impact-of-facial-burns-on-psychosocial-wellbeing-100080022",false,"NCT00297752","Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing","A Randomised Multicentre Clinical Trial on the Efficacy of Flammacerium in the Treatment of Facial Burns and the Impact of Facial Burns on Psychosocial Wellbeing","Inclusion Criteria:\n\n* patients of 18 years of age or older, competent or temporarily incompetent, who are admitted to one of the three dedicated Dutch Burn Centres with burn injuries involving the face\n\nExclusion Criteria:\n\n* patients not seen within 24 hours postburn\n* patients with mental or cognitive deficits that may interfere with providing informed consent\n* patients with poor Dutch proficiency\n* patients with chemical burns","ALL","18 Years",{"count":87,"type":88},154,"ACTUAL","INTERVENTIONAL",[91],"PHASE4","The face is involved in 40-50% of patients with burns admitted to the Dutch Burn Centres. Scarring of the face as a consequence of burns will often have a detrimental effect on function and aesthetics, and may cause negative effects on psychosocial wellbeing. What the best treatment is for facial burns, minimising scarring, is unclear. Besides that, there is little empirical evidence regarding the impact of facial scarring on psychosocial wellbeing.\n\nIn clinical practice good results are felt to be achieved by treatment of facial burns with flammacerium. To substantiate the perceived advantages of flammacerium, its efficacy is compared to flammazine, a current alternative of care. The efficacy of treatment will be assessed in a prospective randomised multicentre clinical trial. Efficacy will be analysed in terms of number of patients requiring surgery and functional and aesthetic outcome.\n\nApart from medical outcome, this study offers the opportunity to study psychosocial problems associated with facial defects. It is still an unresolved question whether facial scarring causes more or different psychosocial problems. Therefore, self-esteem and quality of life will be examined over time, in relation to depression, posttraumatic stress symptoms and other factors, such as coping style and social support.\n\nBy evaluating the efficacy of different treatment strategies, we aim to optimise the standard of care of facial burns. Furthermore, this study wants to shed more light on the psychosocial impact of facial injury. With these results psychosocial professionals will be able to focus on persons at risk and to be better able to meet a patient's personal needs.",[94],"Burns",[96,97,98,99],"facial burns","cerium flammazine","quality of life","randomised clinical trial","COMPLETED","2020-02-13",{"date":103,"type":88},"2020-02-17",{"date":105,"type":40},"2006-03",{"date":107,"type":88},"2008-12",{"name":5,"class":6},3]