[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647280":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":38,"centralContacts":42,"locations":47,"responsibleParty":53,"collaborators":56,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":47,"enrollmentInfo":72,"targetDuration":47,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":94,"whyStopped":47,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":100,"leadSponsor":102,"locationsCount":47},{"fullName":5,"class":6},"St. Antonius Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prophylactic NPWT","EXPERIMENTAL","Following ECMO decannulation, a prophylactic negative pressure wound therapy (NPWT) system is applied under sterile conditions to the closed groin wound in the operating room or ICU. The NPWT system consists of a closed-incision dressing connected to a continuous vacuum device set at -125 mmHg and is maintained for seven days without routine dressing changes. Wound exudate is collected in a canister and monitored during treatment.",[13],"Device: Prophylactic Closed-Incision Negative Pressure Wound Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Wound Care","ACTIVE_COMPARATOR","Following ECMO decannulation, a sterile adhesive dressing is applied under sterile conditions to the closed groin wound in the operating room or ICU. Dressings are managed and changed according to local standard care protocols.",[19],"Device: Standard Wound Dressing",[21,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Prophylactic Closed-Incision Negative Pressure Wound Therapy","Prophylactic closed-incision negative pressure wound therapy (NPWT) is applied immediately following ECMO decannulation to closed groin wounds. The system consists of a sealed dressing connected to a continuous vacuum device set at -125 mmHg and is maintained for seven days without routine dressing changes. This intervention is specifically used to prevent wound complications in high-risk ECMO patients and is applied to one or both groins depending on cannulation.",[9],[27,28,29,30],"NPWT","Closed-Incision NPWT","ciNPWT","Prevena™ system",{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Standard Wound Dressing","Standard wound dressing is applied to closed groin wounds immediately following ECMO decannulation under sterile conditions. The dressing consists of a conventional sterile adhesive covering without the application of negative pressure or active fluid management. Dressings are changed as clinically indicated according to local standard care protocols.",[15],[15,36,37],"Sterile Wound Dressing","Conventional Wound Dressing",[39],{"name":40,"affiliation":5,"role":41},"Erik Scholten, MD","PRINCIPAL_INVESTIGATOR",[43,49],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Ineke van de Pol, RN, MSc","CONTACT","+31883206614",null,"i.van.de.pol@antoniusziekenhuis.nl",{"name":50,"role":45,"phone":51,"phoneExt":47,"email":52},"Margreet van Rees, RN","0883206612","g.van.rees@antoniusziekenhuis.nl",{"type":41,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":47,"oldOrganization":47},"dr. Peter Noordzij, MD PhD","Co-Principal Investigator, Anesthesiologist-Intensivist",[57,60],{"name":58,"class":59},"St. Antonius Onderzoeksfonds","UNKNOWN",{"name":61,"class":59},"St. Antonius innovatiefonds","100647280","closed-incision-npwt-to-prevent-wound-complications-post-ecmo-100647280",false,"NCT07709546","Closed Incision NPWT to Prevent Wound Complications Post-ECMO","The Prophylactic Effect of Closed Incision Negative Pressure Therapy on Vascular Entry Site Complications Following ECMO Decannulation","PREVENT-ECMO","Inclusion Criteria:\n\n* Patient is aged 18 years or older\n* Is currently receiving ECMO therapy and is eligible for weaning from the device\n* The patient must have at least one cannula inserted at the groin site\n* (Proxy) informed consent\n\nExclusion Criteria:\n\n* Duration ECMO run \\\u003C 24 hours\n* Expected death within 24 hours after decannulation\n* Extracorporeal carbon dioxide removal (ECCO2R) using low blood flow devices or pumpless devices (i.e., MINILUNG ®, PrismaLung+)\n* Wound closure is not possible after decannulation.\n* Presence of drain in the wound site\n* Participants who are not proficient in Dutch or English, or whose legal representative is not proficient, if applicable","ALL","18 Years",{"count":73,"type":74},144,"ESTIMATED","INTERVENTIONAL",[77],"NA","Patients undergoing extracorporeal membrane oxygenation (ECMO) are at increased risk of wound complications at the vascular access site after decannulation. These complications may delay recovery and increase healthcare burden. Closed incision negative pressure wound therapy (NPWT) may improve wound healing by reducing fluid accumulation and supporting the incision. This study evaluates whether prophylactic NPWT reduces wound complications compared to standard wound care following ECMO decannulation.",[80,81,82],"ExtraCorporeal Membrane Oxygenation (ECMO)","Wound Complications","Surgical Site Infection (SSI)",[84,85,86,27,87,88,89,81,90,91,92,93],"ECMO","Extracorporeal Membrane Oxygenation","Negative Pressure Wound Therapy","Prevena","Closed Incision Negative Pressure Therapy","ciNPT","Surgical Site Infection","CRWC","Groin wound","Vascular access site","NOT_YET_RECRUITING","2026-07-13",{"date":97,"type":98},"2026-07-16","ACTUAL",{"date":95,"type":74},{"date":101,"type":74},"2029-03-18",{"name":5,"class":6}]