[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"open-abdomen\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:open-abdomen":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,74,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100604828","effects-of-abclo-fascial-approximation-device-in-patients-with-open-abdomen-on-respiratory-mechanics-100604828",false,"NCT07154589","Effects of AbClo Fascial Approximation Device in Patients With Open Abdomen on Respiratory Mechanics","Effects of AbClo Fascial Approximation Device in Patients With Open Abdomen on Respiratory Mechanics (AbClo-Resp)","AbClo-Resp","Inclusion Criteria:\n\n* Adult patients aged 18 years or older\n* Patients admitted to an ICU\n* Patients with postoperative abdominal surgery with open abdomen\n* Patients treated with AbClo device\n* Patients intubated and mechanically ventilated\n* Patients treated with intravenous sedation with a sedation-agitation scale score of 1-3\n\nExclusion Criteria:\n\n* Transient criteria: Patients with severe hemodynamic instability, defined systolic blood pressure less than 75 mmHg or mean arterial pressure less than 60 mmHg despite vasopressor use\n* Transient criteria: Patients with severe bleeding diathesis, defined as the latest platelet count less than 20 · 109\u002FL, or the latest INR higher than 2.0\n* Patients with concurrent injuries to upper gastrointestinal tract that would preclude esophageal balloon insertion\n* Patients with bronchopleural fistula\n* Patients with measured and uncontrolled increased intracranial pressure","ALL","18 Years",{"count":20,"type":21},18,"ESTIMATED","OBSERVATIONAL","Patients who underwent an abdominal surgery and had the abdomen remain open are called to have an \"open abdomen\". To limit the risk of further widening of their wounds, surgeons can use AbClo, which is a non-invasive abdominal binding device, to keep the abdominal wall together (i.e., approximate the fascia). However, as the device also compresses on the abdomen and adjacent lungs, this study aims:\n\n* To assess whether the abdominal binding device causes changes in the pressure compressing the lungs, the lung volume, and the function of the lungs.\n* To assess whether adjusting the breathing machine can mitigate such negative changes.\n\nParticipants will already be on the abdominal binding device when joining the study. Measurements on various aspects of the lung function (including its physical properties and capability to oxygenate the blood) will be done before and after adjustment of the abdominal binding device to the pressure (measured in the device itself) recommended by the manufacturer, as well as after the surgery to close the abdomen.",[25,26],"Open Abdomen","Mechanical Ventilation",[28,29,30],"open abdomen","mechanical ventilation","transpulmonary pressure","RECRUITING","2026-04-16",{"date":34,"type":35},"2026-04-22","ACTUAL",{"date":37,"type":35},"2025-06-10",{"date":39,"type":21},"2026-06",{"name":41,"class":42},"Unity Health Toronto","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"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","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.",{"count":53,"type":21},50,"INTERVENTIONAL",[56],"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.",[59,25,60,61],"Botulinum Toxin Type A","Abdominal Wall","Clinical Trial",[63],"botulinum toxin, open abdomen, laparostomy, abdominal wall closure, clinical trial.","NOT_YET_RECRUITING","2024-08-13",{"date":67,"type":35},"2024-08-15",{"date":69,"type":21},"2025-01",{"date":71,"type":21},"2026-12",{"name":73,"class":42},"Instituto de Investigación Hospital Universitario La Paz",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100549005","damage-control-surgery-over-the-world-in-acute-diverticulitis-dacosad-100549005","NCT06428370","Damage Control Surgery Over the World in Acute Diverticulitis (DACOSAD)","An International Study Investigating the Adoption and Outcome of Damage Control Surgery in Hinchey III-IV Acute Diverticulitis (DACOSAD)","DACOSAD","Inclusion Criteria:\n\n* Patients \\>18 year-old underwent surgery for Hinchey III and IV and submitted to resection, clip and drop, and open abdomen\n\nExclusion Criteria:\n\n* Subjects \\\u003C18 year-old",{"count":83,"type":21},300,"To analyze the possible benefit of damage control surgery by performing bowel resection, open abdomen, and delayed anastomosis in the treatment of Hinchey III or IV diverticulitis.",[86,25],"Diverticular Perforation",[88,89,90,91],"Diverticulitis","Surgery","Open abdomen","Septic shock","2024-06-04",{"date":94,"type":35},"2024-06-05",{"date":96,"type":35},"2020-01-01",{"date":98,"type":21},"2025-06-01",{"name":100,"class":42},"Link Campus University",9,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":54,"phases":112,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":4},"100482915","vacuum-assisted-wound-closure-and-permanent-on-lay-mesh-mediated-fascial-traction-in-patients-with-open-abdomen-100482915","NCT05568238","Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction in Patients With Open Abdomen","Vacuum Assisted Wound Closure and Permanent On-lay Mesh-mediated Fascial Traction (VAWCPOM) in Patients With Open Abdomen - a Prospective Multi-center Cohort Study","VAWCPOM","Inclusion Criteria:\n\n• All patients ≥18 years old treated with an open abdomen with a midline incision, regardless of indication.\n\nExclusion Criteria:\n\n* Patient declining participation\n* Existing incisional hernia or primary ventral hernia ≥3 cm\n* Existing mesh in the abdominal wall, located in the midline and irrespective of mesh size\n* Existing ostomy\u002Fparastomal hernia located in a position that prevents the VAWCPOM technique to be utilized\n* Closure of the abdomen at first dressing change, e. g. without mesh traction",{"count":111,"type":21},100,[113],"NA","Open abdomen therapy is used in trauma and non-trauma patients where the abdomen is not possible to close, or the intraabdominal conditions is not suitable for closure. In 2007, a new technique that made use of negative pressure wound therapy and mesh-mediated fascial traction for closure of the open abdomen was described from the Department of Surgery in Malmö, Sweden. With this new technique, fascial closure rates were high but long-term incisional hernia formation was seen in approximately half of the patients alive after five years. To overcome the high incisional hernia incidence, a new technique utilizing a permanent on-lay mesh for traction and reinforcement of the incision at fascial closure was developed.\n\nHypothesis Lower incisional hernia rates in comparison with literature reported results of other techniques for open abdomen treatment, with similar complication rates.\n\nAims To evaluate early and late clinical outcome of the novel vacuum-assisted wound closure and permanent on-lay mesh-mediated fascial traction technique.\n\nDesign A prospective six-center cohort study in Sweden and Denmark. Study inclusion during a two-year period or longer to include at least 100 patients. Statistical analysis will be done by intention-to-treat and as sub-group per-protocol analysis.",[25,116,117],"Temporary Abdominal Closure","Incisional Hernia","2022-09-30",{"date":120,"type":35},"2022-10-05",{"date":122,"type":21},"2022-10",{"date":124,"type":21},"2027-12",{"name":126,"class":42},"Skane University Hospital"]