[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"burns-and-scalds\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:burns-and-scalds":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100616968","multicenter-randomized-non-inferiority-study-to-compare-the-performance-and-safety-of-debrisoft-duo-with-debrisoft-pad-in-the-debridement-of-wounds-100616968",false,"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","ALL","18 Years",{"count":18,"type":19},104,"ESTIMATED","INTERVENTIONAL",[22],"NA","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.",[25,26,27,28,29,30,31,32,33],"Diabetic Ulcers","Arterial Ulcers","Venous Ulcers","Pressure Ulcers","Postoperative Wounds Healing by Secondary Intention","Burns and Scalds","Epidermolysis Bullosa (EB)","Traumatic Wounds","Surgical Wounds",[35,36],"Debridement","mechanical debridement","RECRUITING","2025-12-17",{"date":40,"type":41},"2025-12-31","ACTUAL",{"date":43,"type":41},"2025-05-09",{"date":45,"type":19},"2026-02",{"name":47,"class":48},"Lohmann & Rauscher","INDUSTRY",5,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":20,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100612619","pmcf-study-of-debridement-pad-100612619","NCT07255937","PMCF Study of Debridement Pad","Post Market Clinical Follow up Study to Confirm the Ongoing Safety and Performance of a Debridement Pad in Superficial, Chronic and Acute Wounds","Inclusion Criteria:\n\n* Males or females aged 18 years or above.\n* Patients who can understand and give informed consent to take part in the study.\n* Have one or more of the following wounds: Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic and surgical wounds, and burns and scalds\n* Wounds that require debridement due to the presence of slough debris\u002Ffibrous tissue ,hyperkeratotic debris and dried exudate on the peri wound skin.\n* Wounds with both serous crusts and healthy tissue.\n* Minimum of 30% of the wound covered by debris, necrosis or slough.\n* Wound Size \\> 4cm2\n\nExclusion Criteria:\n\n* Patients who are known to be non-compliant with medical treatment\n* Patients who are known to be sensitive to any of the device components such as polyester.\n* Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with their ability to participate in the study.\n* Subject is currently enrolled in another clinical study, or has completed a clinical study less than 30 days prior to enrolment.\n* Symptoms \\& signs of systemic and \u002F or spreading wound infection (including erythema and fever).\n* Severe pain (level 7 or higher on a 0-10 VAS or hyperaesthesia in the wound area).\n* Subjects who in the view of the investigator might not be suitable for inclusion in the study",{"count":58,"type":19},184,[22],"The design of the study is a clinical trial of Debridement Pad in subjects with superficial, chronic and acute wounds consisting of Diabetic ulcers, Arterial and Venous Leg ulcers, Pressure ulcers, Postoperative wounds healing by secondary intention, traumatic or surgical wounds and burns and scalds. The performance data from this study will support clinically meaningful rates of successful improvement in wound bed condition immediately after treatment.",[25,62,63,64,65,32,33,30],"Venous Leg Ulcer","Arterial Leg Ulcer","Pressure Ulcer","Postoperative Wound Healing","2025-11-27",{"date":68,"type":41},"2025-12-01",{"date":70,"type":41},"2025-11-20",{"date":72,"type":19},"2026-07-10",{"name":74,"class":48},"Advanced Medical Solutions Ltd.",1]