[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558815":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":39,"locations":26,"responsibleParty":44,"collaborators":26,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":26,"enrollmentInfo":56,"targetDuration":26,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":68,"overallStatus":70,"whyStopped":26,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":26},{"fullName":5,"class":6},"Instituto de Investigación Hospital Universitario La Paz","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","PLACEBO_COMPARATOR","physiological saline 50 cc",[13],"Other: CONTROL",{"label":15,"type":16,"description":17,"interventionNames":18},"botulinum toxin","EXPERIMENTAL","Intramuscular injection into the flat muscles of the abdominal wall of 300\u002F500 Units of botulinum toxin A dissolved in 100 cc of physiological saline, distributed in 5 points on each side of the abdomen in the first 48 hours after leaving the abdomen open.",[19],"Drug: Botulinum Toxin A",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Botulinum Toxin A","Botulinum Toxin",[15],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"CONTROL","Saline Solution",[9],[32,36],{"name":33,"affiliation":34,"role":35},"Victor Vaello Jodra, Consultant","Hospital Universitario del Henares","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":35},"Luis Asensio Gomez, Consultant","Hospital Universitario La Paz",[40],{"name":33,"role":41,"phone":42,"phoneExt":26,"email":43},"CONTACT","0034 696550460","botuclosure@gmail.com",{"type":45,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100558815","phase-4-a-multicentre-randomised-single-blind-controlled-protocol-to-evaluate-the-efficacy-of-early-administration-of-botulinum-toxin-for-primary-midline-closure-in-patients-with-open-abdomen-100558815",false,"NCT06556030","A Multicentre, Randomised, Single-blind, Controlled Protocol to Evaluate the Efficacy of Early Administration of Botulinum Toxin for Primary Midline Closure in Patients With Open Abdomen.","Botulinum Toxin in Open Abdomen Closure","BOTU-CLOSURE","Inclusion Criteria:\n\n* 1\\. Subjects must be able to understand the purpose and risks of the study, giving informed consent and authorising the use of confidential health information. If the patient is unable to consent due to emergency status, a first or second degree relative will be requested. If the patient recovers, the patient\\'s consent to continue participation will be sought again.\n\n  2\\. Subjects Patients over 18 years of age who, regardless of the cause, have undergone abdominal surgery, after which it has been necessary to leave the abdomen open.\n\n  3\\. Subjects able and willing to participate and to be followed for most of the duration of the study.\n\nExclusion Criteria:\n\n* Personal historyDiseases which, in the opinion of the investigator, may interfere with or worsen the action of the botulinum toxin. For example, patients with: hyperthyroidism, neuromuscular disease, myasthenia gravis, Eaton Lamber syndrome or ALS are excluded.\n\n  2\\. Drugs that affect muscle tone or the autonomic nervous system, e.g. administration of antibiotics such as aminoglycosides, lincosamides, polymyxins or tetracyclines.\n\n  3\\. Pregnancy or lactation. 4. Known hypersensitivity. 5. Active neoplastic disease.","ALL","18 Years",{"count":57,"type":58},50,"ESTIMATED","INTERVENTIONAL",[61],"PHASE4","A multicentre, randomised, single-blind, controlled protocol to evaluate the efficacy of early administration of botulinum toxin for primary midline closure in patients with open abdomen. Early use (less than 48 hours) of botulinum toxin as a neuromuscular abdominal wall blocker in patients whose abdomen is left open, regardless of the cause, will improve postoperative outcome and prognosis, leading to significantly higher percentages of primary midline closure.",[64,65,66,67],"Botulinum Toxin Type A","Open Abdomen","Abdominal Wall","Clinical Trial",[69],"botulinum toxin, open abdomen, laparostomy, abdominal wall closure, clinical trial.","NOT_YET_RECRUITING","2024-08-13",{"date":73,"type":74},"2024-08-15","ACTUAL",{"date":76,"type":58},"2025-01",{"date":78,"type":58},"2026-12",{"name":5,"class":6}]