[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637979":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":83,"collaborators":87,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":18,"enrollmentInfo":105,"targetDuration":18,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":121,"whyStopped":18,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"School of Health Sciences Geneva","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"POLTX_Fiber arm","EXPERIMENTAL","POLTX\\_Fiber, an absorbent gelling fiber dressing for moderate-high exudate chronic wounds",[13],"Combination Product: Politix Fiber arm",{"label":15,"type":16,"description":17,"interventionNames":18},"Suprasorb® Liquacel Pro, CE-marked gelling fiber dressing","NO_INTERVENTION","Suprasorb® Liquacel Pro arm",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"COMBINATION_PRODUCT","Politix Fiber arm","POLTX\\_Fiber, an absorbent gelling fiber dressing for moderate-high exudate chronic wounds, applied strictly per IFU and local protocol.\n\nApplication workflow (per visit). It will proceed as follows:\n\n* Removal of old dressing.\n* Application of analgesic if necessary (timed to peak during debridement\u002Fdressing).\n* Debridement if necessary (sharp\u002Fhydrolytic per local practice; document method\u002Fdate).\n* Wound cleansing (sterile 0.9% saline or Ringer's; no antiseptics) (IWII 2025).\n* Application of a suitable secondary dressing according to wound phase and medical prescription to secure the primary and maintain moisture balance.\n* Compression therapy for venous disease according to the standardized procedure described in Section 6.1; apply off-loading for DFU per local SOP where indicated.\n* Documentation in the eCRF (Imito Wound® digital photographs\u002Fplanimetry, tissue composition, exudate character, TILI infection score, VAS pain, any device deficiencies).",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Sebastian Probst, Prof. Dr.","CONTACT","41 22-558-6563","sebastian.probst@hesge.ch",{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},"André Frei, MSc","41 22-558-6050","andre.frei@hesge.ch",[36,54,69],{"facility":37,"status":18,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Geneva University Hospitals","Geneva","Canton of Geneva","1205","Switzerland","CH",{"type":44,"coordinates":45},"Point",[46,47],6.14569,46.20222,{"lat":47,"lon":46},[50],{"name":51,"role":28,"phone":52,"phoneExt":18,"email":53},"Damien Pastor, MD","41223723311","damien.pastor@hug.ch",{"facility":55,"status":18,"city":56,"state":57,"zip":58,"country":41,"countryCode":42,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Lausanne University Hospital","Lausanne","Canton of Vaud","1002",{"type":44,"coordinates":60},[61,62],6.63282,46.516,{"lat":62,"lon":61},[65],{"name":66,"role":28,"phone":67,"phoneExt":18,"email":68},"Lucie charbonneau, MSc, RN","41213141111","lucie.charbonneau@chuv.ch",{"facility":70,"status":18,"city":71,"state":57,"zip":72,"country":41,"countryCode":42,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Instituions Hospital Du Nord Vaudois","Yverdon-les-Bains","1400",{"type":44,"coordinates":74},[75,76],6.64115,46.77852,{"lat":76,"lon":75},[79],{"name":80,"role":28,"phone":81,"phoneExt":18,"email":82},"Carole Guex, RN, DAS in Wound Care","412442424444","carole.guex@hesge.ch",{"type":84,"investigatorFullName":85,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Sebastian Probst","Professor of Tissue Viability and Wound Care",[88,91,93],{"name":89,"class":90},"eHnv Hospital","UNKNOWN",{"name":92,"class":6},"University Hospital, Geneva",{"name":94,"class":90},"CHUV, Lausanne University Hospitals, Switzerland","100637979","short-term-safety-and-performance-of-two-wound-dressings-evaluation-100637979",false,"NCT07576322","Short-Term Safety and Performance of Two Wound Dressings Evaluation","A Post-Market Clinical Follow-Up Study to Evaluate Short-Term Safety and Performance of POLTX_Fiber Compared With Suprasorb Liquacel Pro in Chronic Wounds","POLTX_Fiber","Inclusion Criteria:\n\nAge ≥ 18 years Chronic wound of 4 weeks to 2 years in duration Moderate to highly exuding wound (clinician-assessed) Wound area 2-50 cm² after debridement Able and willing to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\nKnown hypersensitivity to study or comparator dressing components Clinically infected wound requiring systemic antibiotics at baseline Necrotic wound (\\>25% necrotic tissue) or malignant wound Severe arterial insufficiency (ABI \\\u003C 0.5) Pregnant or breastfeeding Severe comorbid condition likely to interfere with wound healing or safety evaluation (e.g., end-stage renal disease, active cancer on chemotherapy, immunosuppression) Participation in another interventional study within 30 days Use of investigational wound products within 30 days Cognitive or psychiatric condition limiting consent or compliance Unable to attend follow-up visits or likely to relocate during the study period Any condition that, in the investigator's judgment, may compromise safety or study integrity","ALL","18 Years",{"count":106,"type":107},60,"ESTIMATED","INTERVENTIONAL",[110],"NA","Chronic wounds, including venous leg ulcers, diabetic foot ulcers, and pressure ulcers, are defined as wounds that fail to heal within 4-8 weeks despite appropriate care. They represent a significant health burden due to prolonged healing, risk of infection, recurrence, and impact on quality of life and healthcare costs. Their development is multifactorial and often linked to vascular impairments, which reduce oxygen and nutrient supply. This leads to impaired tissue repair, persistent inflammation, and increased susceptibility to infection.\n\nStandard treatment includes wound debridement, infection control, maintaining a moist environment, and managing pain and exudate. POLTX\\_Fiber is an absorbent gelling fiber dressing designed to improve moisture balance, manage exudate, and reduce bacterial load, with established safety and CE marking.\n\nA post-market clinical follow-up study will compare POLTX\\_Fiber with Suprasorb® Liquacel Pro over a 30-day period in an outpatient setting. The study evaluates wound healing, infection status, usability, pain, and patient satisfaction. It is conducted in accordance with EU and Swiss regulations, ensures qualified investigators, and considers sex and gender differences in the analysis.",[113,114,115],"Chronic Wound Care","Local Infection","Safety",[117,118,119,120],"chronic wound","local infection prevention","wound exudate","safety","NOT_YET_RECRUITING","2026-05-04",{"date":124,"type":125},"2026-05-08","ACTUAL",{"date":127,"type":107},"2026-06-15",{"date":129,"type":107},"2027-09-30",{"name":85,"class":6},3]