[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lohmann & Rauscher\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":149},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,68,99,123],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100609183","suprasorbxphmb-pro-vs-suprasorbxphmb-in-treatment-of-infected-venous-leg-ulcers-100609183",false,"NCT07211243","Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of Infected Venous Leg Ulcers","Multicenter, Randomised in Parallel Groups, Controlled Study to Compare Performance and Safety of Suprasorb®X+PHMB Pro With Suprasorb® X+PHMB Dressing in Treatment of Infected Venous Leg Ulcers","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Infected\\* venous\\*\\* leg ulcer\n* Slightly to moderately exuding wound\\*\\*\\*\n* Patient has signed informed consent\n\n  * as per CDC definition, also TILI score ≥ 5 \\*\\* ABPI \\> 0.8 and \\\u003C 1.2 \\*\\*\\* patients with highly exuding wounds may be screened for a 7 days run-in period to receive superabsorbent dressing and monitored compression therapy and re-con-sidered for enrolment in case the exudation level decreases\n\nExclusion Criteria:\n\n* Participation in other interventional clinical trial that could interfere with the present study within 4 weeks of the randomisation and during the whole duration of this study\n* Wounds with exposed cartilage tissue (hyaline cartilage)\n* Contraindications to compression therapy (e.g.: advanced peripheral ar-terial occlusive diseases, decompensated cardiac insufficiency, septic phlebitis, phlegmasia coerulea dolens, sensation disorders of the skin)\n* Known allergy and\u002For hypersensitivity to any components of the study product or concomitant products (e.g. compression bandage)\n* Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and \u002F or interpreta-tion of the study results.","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"NA","This clinical investigation will be conducted as a multicentre, open-label, randomised in parallel groups, controlled study on patients with infected venous leg ulcers.",[26],"Venous Leg Ulcer",[28,29,30,31],"maceration","bacterial cellulose dressing","PHMB","antimicrobial dressing","RECRUITING","2026-03-26",{"date":35,"type":36},"2026-04-01","ACTUAL",{"date":38,"type":36},"2025-09-23",{"date":40,"type":20},"2027-06-15",{"name":42,"class":43},"Lohmann & Rauscher","INDUSTRY",9,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100617279","post-marketing-surveillance-of-vliwazell-prowound-dressing-100617279","NCT07316556","Post-Marketing Surveillance of Vliwazell® Prowound Dressing","Prospective Systematic Data Collection for Post-Marketing Surveillance of Vliwazell® Pro Wound Dressing","Vliwazell","Inclusion Criteria:\n\nWound according to indication mentioned in the instructions for use:\n\n1. Superficial acute and chronic wounds with moderate to very high amounts of exudate and that are superficial, in:\n\n   * arterial and venous ulcers\n   * diabetic ulcers\n   * pressure ulcers\n   * post-traumatic wounds\n   * post-operative wounds healing by secondary intention\n   * skin graft donor sites\n   * oncological wounds\n   * ulcerating tumors\n   * wounds at risk of infection\n   * superficial 2nd degree burns\n   * lymphatic wounds\n2. As secondary dressing on laparotomy wounds and fistulas or for deep wounds when used with appropriate wound filler\n3. Patient has full legal capacity\n4. Patient is able to understand and provide information\n5. Patient has signed the written Informed Consent Form\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years\n2. Patient with contraindication:\n\n   * Known allergy and\u002For hypersensitivity to any of the product components.\n   * Not for use in tunnel-forming wound pockets, as the product may expand considerably with the absorption of wound exudate.\n   * Not for use on dry wounds.\n3. Pregnant or lactating women\n4. Patients participating in another clinical trial at the time of inclusion\n5. Patient not covered by health insurance\u002Fsocial security",{"count":54,"type":20},208,"OBSERVATIONAL","This PMCF study is conducted to confirm the effectiveness and safety of the wound dressing Vliwazell® Pro. The aim of the study is to validate the performance of Vliwazell® Pro within its intended purpose and certified indications during routine use, and to gather additional safety data. The study will examine how the use of the dressing affects the condition of the skin surrounding the wound, the wound status in terms of exudate, wound odor, and other parameters. Furthermore, the satisfaction of healthcare providers and patients with the application of the dressing will be assessed.",[58],"Acute and Chronic Wounds","2025-12-18",{"date":61,"type":36},"2026-01-05",{"date":63,"type":36},"2024-03-11",{"date":65,"type":20},"2027-01-31",{"name":42,"class":43},8,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":88,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":5},"100616968","multicenter-randomized-non-inferiority-study-to-compare-the-performance-and-safety-of-debrisoft-duo-with-debrisoft-pad-in-the-debridement-of-wounds-100616968","NCT07312513","Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient is legally capable\n* Patient has signed written informed consent\n* Presence of one of the following wounds\n\n  * Venous lower leg ulcer\n  * Arterial ulcer\n  * Diabetic ulcer\n  * Pressure ulcer\n  * Post-operative wound healing by secondary intention\n  * Traumatic wound\n  * Surgical wound\n  * Burn or scald (grade III: after surgical debridement)\n  * Epidermolysis Bullosa\n* Wound area \\>4cm2\n* The entire wound area can be displayed on one photo from a distance of 25-30 cm\n* Covered with at least 30% debris, necrosis, slough, fibrotic tissue\n\nExclusion Criteria:\n\n* Known allergy and\u002For hypersensitivity to Debrisoft® Duo or any of the product components\n* Pregnancy or breast feeding\n* Patient is illiterate\n* Participation in a interventional clinical trial within the last 14 days and during participation in this study\n* Any other medical condition, which, by opinion of the investigator, may have impact of the success of the study treatment and\u002F or interpretation of the study results\n* severe pain or hyperesthesia in the wound area\n* history of drug or alcohol abuse\n* chronic analgesic use (especially opioids) that could influence baseline pain perception\n* cognitive impairment, which may affect the ability to accurately self-report pain\n* Use of anaesthesia before the debridment procedure\n* presence of hard necrotic tissue or other tissue which should not be debrided in general. Other types of hard necrotic tissue requiring debridement, as determined by the investigator, are permitted and may be also pre-moistened before the procedure if deemed necessary",{"count":75,"type":20},104,[23],"The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with the use of Debrisoft® Duo within the certified indications and under the conditions of routine use.",[79,80,81,82,83,84,85,86,87],"Diabetic Ulcers","Arterial Ulcers","Venous Ulcers","Pressure Ulcers","Postoperative Wounds Healing by Secondary Intention","Burns and Scalds","Epidermolysis Bullosa (EB)","Traumatic Wounds","Surgical Wounds",[89,90],"Debridement","mechanical debridement","2025-12-17",{"date":93,"type":36},"2025-12-31",{"date":95,"type":36},"2025-05-09",{"date":97,"type":20},"2026-02",{"name":42,"class":43},{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":109,"studyType":55,"phases":4,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},"100475848","suprasorb-cnpendo-used-for-negative-pressure-therapy-in-the-oesophagus-and-rectum-to-support-defect-and-wound-healing-100475848","NCT05476263","Suprasorb® CNPendo Used for Negative Pressure Therapy in the Oesophagus and Rectum to Support Defect and Wound Healing","Non-interventional, Observational, Prospective, Multicentre Study in a Routine Clinical Care Setting Using a Marketed Medical Device in Line With the Corresponding IFU in the Intended Patient Population","Velox","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Acute transmural defects, injuries and wounds in oesophagus or rectum, including perforations (iatrogenic or spontaneous) and anastomotic insufficiencies (Index defect)\n* Indication of treatment with Suprasorb® CNPendo system according to IFU and medical guidelines\n* Signed informed consent for usage of data\n\nExclusion Criteria:\n\n* Pre-existing coagulation disorders with increased risk of bleeding\n* Defects involving the bronchial system (bronchus\u002Ftrachea\u002Fpulmo)\n* Any foreseeable deviation from IFU of Suprasorb® CNP endo\n* Known intolerance or allergy to one or more components of Suprasorb® CNPendo",{"count":108,"type":20},110,"3 Months","A Post-Market Clinical Follow-up (PMCF) study designed as non-interventional, observational, prospective, multicentre study in a routine clinical care setting using a marketed medical device in line with the corresponding Instruction for Use (IFU) in the intended patient population.\n\nPatients will be diagnosed and evaluated for eligibility in routine clinical care by expert centres in the indication of interest. They will be consecutively enrolled into the study provided that all inclusion and exclusion criteria are met and written consent is given to use their clinical routine data according to data privacy regulations.\n\nThe study protocol does not define specific study procedures for patients enrolled. Therapies and procedures during the course of this study will be performed according to the decision of the treating physician based on current applicable medical guidelines and on local policy in clinical routine care.",[112,113],"Esophagus Injury","Rectal Lesion","2025-09-11",{"date":116,"type":36},"2025-09-12",{"date":118,"type":36},"2024-06-03",{"date":120,"type":20},"2027-09",{"name":42,"class":43},7,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":130,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},"100572044","investigation-of-a-new-compression-bandage-system-combining-skin-protection-padding-and-compression-in-one-single-bandage-and-comparing-to-an-existing-one-component-bandage-100572044","NCT06728137","Investigation of a New Compression Bandage System Combining Skin Protection, Padding and Compression in One Single Bandage and Comparing to an Existing One-component Bandage.","2023-05 Rosidal® 1C Pilot Study. Prospective, Mono-centric, Observational Randomized Controlled Study in Healthy Volunteers","Inclusion Criteria:\n\n* Healthy intact skin with no clinical signs of chronic venous insufficiency and no signs of any dermatological condition such as eczema or psoriasis as assessed by investigating physician.\n* Ankle circumference \\> 18 cm (2 cm above ankle) as assessed by the investigating physician.\n\nExclusion Criteria:\n\n* Known sensitivity to the study products (Rosidal 1C or Urgo K1) or any of their components\n* Chronic venous disease with CEAP ≥2\n* Ankle Brachial Pressure Index (ABPI) \\\u003C 0.8 or \\>1.3\n* Ankle circumference \\\u003C18 or \\> 32 cm\n* Venous echo-Doppler with recognizable abnormalities\n* History of\n\n  * malignant ulcer\n  * clinically infected wound\n  * peripheral arterial occlusive diseases,\n  * cardiac insufficiency or cardiac disease such as congestive heart failure, coronary artery disease, myocardial infarction, coronary artery bypass graft\n  * cerebrovascular disease\n  * liver or renal disease\n  * septic phlebitis,\n  * phlegmasia coerulea dolens,\n  * sensation disorders of the skin\n  * eczema, psoriasis\n* Use of diuretics, antihypertension or drugs that influence the capillary infiltration\n* Comorbidities that could affect compression therapy, particularly diseases causing oedema\n* Reliable severe malnutrition\n* Diabetes Mellitus\n* BMI \\> 30 kg\u002Fm2\n* Pregnancy or breast feeding\n* Participation in an interventional clinical trial within the last 3 months and during participation in this study\n* Participant is analphabet",true,{"count":132,"type":20},25,"The goal of this study is to learn about the pressure that can be maintained by a new compression bandage over the course of seven days in healthy volunteers. This bandage combines skin protection, padding and compression in one single bandage. It will be applied to the participants lower legs. A similar device will be applied to the other lower leg of the participant. A randomisation method is used for the assignment of the bandages to the participants legs.\n\nResearchers will compare the bandage pressures of both bandages. The so-called sub-bandage pressure will be measured at the day of application and on the next day, the third day and the last day. Participants will also be asked about the wearing comfort of both bandages.",[135],"Healthy Volunteers",[137,138,139],"prospective","monocentric","randomized controlled trial","2025-01-09",{"date":142,"type":36},"2025-01-13",{"date":144,"type":20},"2025-01",{"date":146,"type":20},"2025-04",{"name":42,"class":43},1,""]