[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593961":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":55,"collaborators":24,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":24,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":81,"whyStopped":24,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University Hospital, Bordeaux","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Upper Arm","EXPERIMENTAL","Intervention (botulinum toxin) in the upper half of the scar and placebo in the lower half",[13],"Drug: Botulinum toxin injection",{"label":15,"type":10,"description":16,"interventionNames":17},"Lower Arm","Intervention (botulinum toxin) in the lower half of the scar, and placebo in the upper half.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Botulinum toxin injection","Intervention will be made immediately after surgery, still under general anesthesia, by the cardiac surgeon, after suture.\n\nEach patient will receive (either in the lower part or the upper part of the scar according to randomization) 50 international units (IU) of type A botulinum toxin (Botox®, Allergan aesthetics) diluted in 1 mL of saline to enable injection of 5 IU at each point, every centimeter, at 1 cm of each scar side.\n\nAn equivalent volume of saline will be injected under the same modalities in the other part of the scar.",[15,9],null,[26],{"name":27,"affiliation":5,"role":28},"Robin ZAGALA, MD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":24,"email":33},"CONTACT","+335 56 79 56 79","robin.zagala@chu-bordeaux.fr",{"name":35,"role":31,"phone":36,"phoneExt":24,"email":37},"Claire BAZIN","+335 57 82 25 09","bazin.claire@chu-bordeaux.fr",[39],{"facility":40,"status":24,"city":41,"state":24,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Centre Hospitalier Universitaire de Bordeaux","Bordeaux","33000","France","FR",{"type":46,"coordinates":47},"Point",[48,49],-0.58046,44.84124,{"lat":49,"lon":48},[52,53],{"name":27,"role":31,"phone":32,"phoneExt":24,"email":33},{"name":35,"role":31,"phone":54,"phoneExt":24,"email":37},"+335 57 82 25 21",{"type":56,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100593961","phase-3-botulinum-toxin-injection-after-sternotomies-to-improve-scar-aspect-and-impact-100593961",false,"NCT07013240","Botulinum Toxin Injection After Sternotomies to Improve Scar Aspect and Impact","Immediate Post-surgical Botulinum Toxin Injections to Prevent Dystrophic Scars After Sternotomy : a Placebo-controlled Randomized Clinical Trial","BotuCiSter","Inclusion Criteria:\n\n* Patient aged 18 years or older\n* Scheduled sternotomy at Bordeaux University Hospital within the next 4 months\n* Person affiliated with or benefiting from a social security system\n* Patient able to attend follow-up visits required by the study\n* Free, informed, and written consent signed by the participant or an impartial witness (in case the participant is unable to write) and the investigator (no later than the day of inclusion)\n\nExclusion Criteria:\n\n* Known allergy to botulinum toxin type A or any excipient in BOTOX® (human albumin, sodium chloride)\n* Neuromuscular transmission disorder (myasthenia gravis or Lambert-Eaton syndrome)\n* Motor peripheral neuropathy (such as amyotrophic lateral sclerosis or motor neuropathy)\n* Infection at the injection sites\n* Pregnancy or breastfeeding\n* Person under protection measures","ALL","18 Years",{"count":68,"type":69},50,"ESTIMATED","INTERVENTIONAL",[72],"PHASE3","Sternotomy scars, which are localized in a high-tension area are often dystrophic, hypertrophic or keloidal, and can be difficult to accept to patients who already endured a heavy intervention with high psychologic impact. The investigators wish to evaluate immediate post-surgical injection of botulinum toxin to improve scar aspect and impact. A randomized, placebo-controlled, split-scar clinical trial will determine the improvement of scar aspects assessed by standardized scores (SBSES, POSAS), patient satisfaction and tolerance.",[75],"Sternotomy Closure,Open Heart Surgery",[77,78,79,80],"scar","keloid","botulinum toxin","sternotomy","NOT_YET_RECRUITING","2025-06-02",{"date":84,"type":85},"2025-06-10","ACTUAL",{"date":87,"type":69},"2025-07-05",{"date":89,"type":69},"2027-02-28",{"name":5,"class":6},1]