[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596071":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":42,"responsibleParty":61,"collaborators":32,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":32,"enrollmentInfo":74,"targetDuration":32,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":94,"overallStatus":45,"whyStopped":32,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Region Skane","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Negative Pressure Wound Therapy (NPWT)","EXPERIMENTAL","Participants in this arm will receive negative pressure wound therapy (NPWT) applied over the split-thickness skin graft after excision of a skin tumour on the lower leg. NPWT will be applied according to manufacturer instructions, using a protective interface layer and continuous negative pressure of -125 mmHg until postoperative day 5.",[13],"Device: Negative Pressure Wound Therapy (NPWT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Traditional Dressings","ACTIVE_COMPARATOR","Participants in this arm will receive traditional dressings applied over the split-thickness skin graft after excision of a skin tumour on the lower leg. The dressing will include a protective silicone interface layer and foam dressing with gentle compression, left undisturbed until postoperative day 5.",[19],"Other: Traditional Dressing",[21,28],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Negative pressure wound therapy (NPWT) applied over the split-thickness skin graft on the lower leg after tumour excision. A protective silicone interface layer will be used, with continuous negative pressure of -125 mmHg applied until postoperative day 5, unless earlier change is clinically indicated.",[9],[26,27],"VAC Therapy","Negative Pressure Dressing",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Traditional Dressing","Traditional dressing applied over the split-thickness skin graft on the lower leg after tumour excision. The dressing consists of one or more layers of foam dressing applied on top, which may or may not be fixed with sutures according to surgeon preference, and an elastic bandage applied over the foam to provide gentle, even compression and immobilisation of the graft. The dressing will remain undisturbed until postoperative day 5 unless earlier change is clinically indicated.",[15],null,[34,39],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Pooya Rajabaleyan, MD, PhD","CONTACT","+4640331000","Pooya.rajabaleyan@skane.se",{"name":40,"role":36,"phone":37,"phoneExt":32,"email":41},"Mia Stiernman, MD, PhD","mia.stiernman@med.lu.se",[43],{"facility":44,"status":45,"city":46,"state":32,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Dept. of Plastic and Reconstructive Surgery and Dept. of Health Sciences, Skåne University Hospital, Malmö, Sweden.","RECRUITING","Malmö","20501","Sweden","SE",{"type":51,"coordinates":52},"Point",[53,54],13.00073,55.60587,{"lat":54,"lon":53},[57,58,59],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},{"name":40,"role":36,"phone":37,"phoneExt":32,"email":41},{"name":35,"role":60,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"type":60,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Pooya Rajabaleyan","Negative pressure wound therapy for split thickness skin grafting to the lower leg after excision of skin tumour: The Legs Trial - A multicentre randomised study","100596071","negative-pressure-wound-therapy-for-split-thickness-skin-grafting-to-the-lower-leg-after-excision-of-skin-tumour-a-multicentre-randomised-study-100596071",false,"NCT07040683","Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: A Multicentre Randomised Study","Negative Pressure Wound Therapy for Split Thickness Skin Grafting to the Lower Leg After Excision of Skin Tumour: The Legs Trial - A Multicentre Randomised Study","LEGS","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Undergoing excision of a skin tumour on the lower leg with planned coverage using split-thickness skin grafting (STSG)\n* Eligible procedures include primary excision, secondary excision, or extended excision performed at the same site as a previous tumour surgery\n* Ability to provide written informed consent\n* Ability to comply with postoperative instructions and follow-up visits\n\nExclusion Criteria:\n\n* Inability to follow postoperative instructions due to cognitive impairment, dementia, or significant language barriers\n* Inability to provide informed consent\n* Severe systemic illness, including:\n* Ongoing sepsis\n* Advanced heart failure\n* End-stage renal or liver disease\n* Active chemotherapy within the previous three months\n* Ongoing treatment with immunosuppressive medications, including:\n* Systemic corticosteroids (e.g., prednisone \\>20 mg\u002Fday or equivalent)\n* Calcineurin inhibitors (e.g., cyclosporine, tacrolimus)\n* Antimetabolites (e.g., methotrexate, azathioprine, mycophenolate mofetil)\n* mTOR inhibitors (e.g., sirolimus, everolimus)\n* Biologic therapies (e.g., rituximab, TNF inhibitors, IL-6 inhibitors, IL-1, IL-17, IL-23 inhibitors)\n* Targeted molecular therapies (e.g., JAK inhibitors such as tofacitinib, baricitinib)\n* Other immunosuppressive drugs\n* Previous radiation therapy to the surgical site\n* Presence of severe skin disease affecting the planned graft recipient site (e.g., advanced psoriasis)","ALL","18 Years",{"count":75,"type":76},242,"ESTIMATED","INTERVENTIONAL",[79],"NA","The goal of this clinical trial is to compare the effect of negative pressure wound therapy (NPWT) versus traditional dressings on the incidence of transplant infection in adult patients undergoing split-thickness skin grafting (STSG) to the lower leg following excision of a skin tumour. The main questions it aims to answer are:\n\nDoes NPWT reduce the incidence of transplant infection within three months after STSG?\n\nDoes NPWT improve secondary outcomes such as graft take, reduce reoperations, complications, and resource use?\n\nResearchers will compare patients treated with NPWT to patients treated with traditional dressings to see if NPWT results in lower infection rates and better clinical outcomes.\n\nParticipants will:\n\nUndergo excision of a skin tumour on the lower leg followed by STSG.\n\nBe randomized to receive either NPWT or traditional dressings applied over the graft.\n\nFollow a structured postoperative care and mobilisation schedule.\n\nAttend follow-up visits at day 5 and day 14 postoperatively and be monitored through medical record review up to three months after surgery.",[82,83,84,85,86,87,88,89,90,91,92,93],"Skin Transplantation","Skin Grafting","Split Thickness Skin Graft","Negative-Pressure Wound Therapy","Postoperative Complications","Surgical Wound Infection","Lower Extremity","Skin Cancer","Skin Tumour","Wound Healing","Bandages","Leg",[82,83,95,85,86,87,88,91,92,93,96,89],"Split Thickness","Skin Neoplasms","2026-05-27",{"date":99,"type":100},"2026-05-28","ACTUAL",{"date":102,"type":100},"2025-11-01",{"date":104,"type":76},"2030-03-31",{"name":5,"class":6},1]