[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657175":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":31,"studyPopulation":22,"armGroups":32,"interventions":44,"overallOfficials":22,"centralContacts":54,"locations":22,"responsibleParty":60,"collaborators":22,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":22,"enrollmentInfo":75,"targetDuration":22,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":88,"overallStatus":101,"whyStopped":22,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":22},{"fullName":5,"class":6},"Hospital San Juan de Dios Tenerife","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Incisional Hernia","o evaluate the occurrence of incisional hernia following definitive fascial closure in patients undergoing open abdomen management, comparing patients who receive prophylactic onlay mesh reinforcement with those who do not receive prophylactic mesh.","12 months following definitive fascial closure.",[14,18],{"measure":15,"description":16,"timeFrame":17},"Burst abdomen rate","To evaluate the occurrence of fascial dehiscence (burst abdomen) following definitive fascial closure.","1 month after surgery",{"measure":19,"description":20,"timeFrame":21},"Surgical Site Occurrence","o evaluate the incidence of superficial, deep, or organ\u002Fspace surgical site complications related to the surgical procedure.","30 days after surgery",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":26,"primaryPurpose":27,"observationalModel":22,"timePerspective":22,"maskingInfo":28},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups: definitive fascial closure without prophylactic mesh placement or definitive fascial closure with placement of a synthetic prophylactic onlay mesh. Clinical follow-up will be conducted for at least 12 months after surgery to evaluate the incidence of incisional hernia and associated postoperative complications.","PREVENTION",{"masking":29,"maskingDescription":30,"whoMasked":22},"NONE","No masking will be applied in this study. Both the surgeons and the investigators will be aware of the participants' group allocation due to the surgical nature of the procedure and the need to document the intraoperative management performed.","This study will evaluate the impact of synthetic prophylactic onlay mesh placement during definitive fascial closure in patients managed with an open abdomen approach following emergency surgery.\n\nThis is a single-center randomized clinical trial with a 1:1 allocation to two treatment groups: definitive fascial closure with prophylactic mesh and definitive fascial closure without mesh. The study will include adult patients treated in the General Surgery Department of the Hospital Universitario Nuestra Señora de Candelaria who required open abdomen management and in whom definitive fascial closure can be achieved.\n\nThe primary outcome will be the incidence of incisional hernia during postoperative follow-up. Secondary outcomes will include the occurrence of evisceration and surgical site complications, including infection, seroma, hematoma, enteroatmospheric fistula, and the need for surgical reintervention.\n\nPatients will undergo protocolized follow-up for at least 12 months after definitive fascial closure through outpatient general surgery visits, including physical examination and imaging studies when necessary.\n\nThe purpose of the study is to obtain preliminary evidence regarding the efficacy and safety of prophylactic mesh in this clinical setting, with the aim of optimizing open abdomen management and reducing the incidence of incisional hernia and other abdominal wall complications.",[33,38],{"label":34,"type":6,"description":35,"interventionNames":36},"Definitive Fascial Closure Without Prophylactic Mesh","Patients will undergo definitive fascial closure following open abdomen management, without placement of prophylactic mesh. Perioperative management and clinical follow-up will be conducted according to the standard practice of the department.",[37],"Procedure: Definitive Fascial Closure Without Prophylactic Mesh",{"label":39,"type":40,"description":41,"interventionNames":42},"Definitive Fascial Closure With Prophylactic Onlay Mesh","EXPERIMENTAL","Patients will undergo definitive fascial closure following open abdomen management, with placement of a synthetic, macroporous, non-absorbable prophylactic mesh (Optilene®, B. Braun Surgical S.A.) in the onlay position.",[43],"Device: Prophylactic Onlay Mesh Placement",[45,49],{"type":46,"name":34,"description":47,"armGroupLabels":48,"otherNames":22},"PROCEDURE","Patients will undergo definitive fascial closure following open abdomen management, without placement of prophylactic mesh.",[34],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":22},"DEVICE","Prophylactic Onlay Mesh Placement","Following definitive fascial closure in patients undergoing open abdomen management, a medium-density, macroporous, non-absorbable synthetic mesh (Optilene®, B. Braun Surgical S.A.) will be placed in the onlay position as prophylactic reinforcement of the abdominal wall. The procedure will be performed during the definitive surgical intervention according to the standard practice of the General Surgery Department.",[39],[55],{"name":56,"role":57,"phone":58,"phoneExt":22,"email":59},"Julen Julen Ramón Rodríguez","CONTACT","34672255215","julentxu_92@hotmail.com",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":64,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Julen Ramon Rodríguez","Principal Investigator, General Surgery","University Hospital of the Nuestra Señora de Candelaria","100657175","synthetic-mesh-for-prevention-of-hernia-after-open-abdomen-closure-study-100657175",false,"NCT07835334","Synthetic Mesh for Prevention of HernIa After opEn Abdomen cLosure stuDy","Synthetic Mesh for Prevention of HernIa After opEn Abdomen cLosure stuDy (SHIELD Study)","SHIELD","Inclusion Criteria:\n\n* Patients older than 18 years.\n* Patients managed with an open abdomen approach.\n* Patients undergoing definitive fascial closure.\n\nExclusion Criteria:\n\n* Patients in whom definitive fascial closure cannot be achieved.\n* Inability to complete clinical follow-up or high likelihood of loss to follow-up (e.g., residence outside the catchment area, lack of outpatient follow-up, etc.)","ALL","18 Years",{"count":76,"type":77},30,"ESTIMATED","INTERVENTIONAL",[80],"NA","The aim of this clinical trial is to evaluate whether placement of a synthetic prophylactic onlay mesh during definitive fascial closure can reduce the incidence of incisional hernia in adult patients managed with an open abdomen approach following emergency surgery.\n\nThe main questions it aims to answer are:\n\n* Does prophylactic mesh placement reduce the incidence of incisional hernia compared with fascial closure without mesh?\n* Does prophylactic mesh placement influence the occurrence of postoperative complications such as evisceration or surgical site infection?\n\nResearchers will compare patients undergoing definitive fascial closure with prophylactic mesh placement to those undergoing fascial closure without mesh in order to determine whether the mesh decreases the incidence of incisional hernia and associated complications.\n\nParticipants will:\n\n* Undergo standard open abdomen management followed by definitive fascial closure.\n* Be randomly assigned to one of the two study groups:\n\n  * Definitive fascial closure without prophylactic mesh.\n  * Definitive fascial closure with placement of a synthetic prophylactic onlay mesh.\n* Attend clinical follow-up visits in the general surgery outpatient clinic.\n* Undergo clinical evaluations at 1, 6, and 12 months after surgery, including physical examination and, if necessary, imaging studies to detect incisional hernia or postoperative complications.",[83,84,85,86,87],"Open Abdomen","Incisional Hernia","Definitive Fascial Closure","Emergency Abdominal Surgery","Prevention of Incisional Hernia Using Prophylactic Mesh",[89,90,91,92,93,94,95,96,97,98,99,100],"Open abdomen","Incisional hernia","Prophylactic mesh","Definitive fascial closure","Emergency surgery","Negative pressure wound therapy","NPWT","Damage control surgery","Abdominal wall","Onlay mesh","Surgical complications","Emergency abdominal surgery","NOT_YET_RECRUITING","2026-09-17",{"date":104,"type":105},"2026-09-22","ACTUAL",{"date":107,"type":77},"2026-09-01",{"date":109,"type":77},"2027-09-01",{"name":5,"class":6}]