[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biofilm-formation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biofilm-formation":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":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100623062","early-phase-1-efficacy-of-a-polyhexanide-biguanide-based-gel-in-the-prevention-of-biofilm-formation-in-pressure-ulcers-100623062",false,"NCT07391748","Efficacy of a Polyhexanide Biguanide-Based Gel in the Prevention of Biofilm Formation in Pressure Ulcers","EGELPUPP","Inclusion Criteria:\n\n* Bedridden patients, patients with bed-to-chair mobility, or those in a wheelchair.\n* Presenting one or more category II-III pressure ulcers.\n* Aged over 65 years.\n* Patients with laboratory results within normal metabolic values (HbA1c \\\u003C 7%).\n* Patients who, in item 6 \"infection\u002Fsuspected biofilm\" of the RESVECH 2.0 index, do not have tissue compatible with biofilm, hypergranulation, or purulent exudate, and never score more than 4 in the other items.\n* During follow-up, cases that develop signs and symptoms of local infection according to TILI and\u002For the RESVECH 2.0 index will be considered therapeutic failures, allowing for clinical rescue, but the patient will remain in the intention-to-treat (ITT) analysis.\n\nExclusion Criteria:\n\n* Patients who, despite the above, present a deteriorated health status that could influence the outcome, such as terminally ill patients, oncology patients, or those with inflammatory diseases.\n* Patients in a state of malnutrition according to the Mini Nutritional Assessment (MNA®) scale who are not receiving nutritional supplements, and\u002For at risk of malnutrition with nutritional deficits.\n* Patients with pressure ulcers in the perineal area and urinary incontinence (except those with a urinary catheter) and\u002For fecal incontinence.","ALL","65 Years",{"count":19,"type":20},140,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","INTRODUCTION: Pressure ulcers (PU) are one of the main challenges for nursing in our country. Wound bed preparation and the TIME algorithm provide essential tools for adequately treating these lesions. However, these wounds tend to become chronic due to the bacterial load in their bed. It is now known that bacteria can form complex and diverse structures, named as biofilm, which are difficult to diagnose and much more resistant to antimicrobial action.\n\nControlling these biofilms is crucial to create the optimal conditions for wound healing. Currently, it is believed that biofilms are present in 60-100% of chronic wounds. Therefore, more studies are needed to evaluate the efficacy of different antimicrobial agents on these structures.\n\nOBJECTIVE: To determine the efficacy of a gel containing polyhexanide and biguanide, alone or in combination with alginate with or without silver, in preventing biofilm in PU, in terms of healing at 4 weeks.\n\nMETHODOLOGY: Multicenter clinical trial with a 2x2 factorial design, conducted with patients from Alcoy with category II and III PUs that meet the inclusion and exclusion criteria. A sample of 140 participants is estimated, distributed into four groups of 35 patients. The interventions that will be carried out will be: application of Prontosan gel® and Aquacel Ag+®; Aquacel Ag+®; control group; Prontosan gel®. Data on wound evolution will be collected using RESVECH 2.0. Descriptive statistical analysis and hypothesis testing will be performed.",[26,27,28,29,30,31,32],"Pressure Ulcers","Pressure Ulcers Stage III","Pressure Ulcer Prevention","Pressure Ulcer ( Stage 2-3)","Biofilm Formation","Biofilm","Biofilm Removal",[34,35,36,37],"Pressure ulcers","biofilms","primary prevention","antimicrobial agents","NOT_YET_RECRUITING","2026-02-06",{"date":41,"type":42},"2026-02-10","ACTUAL",{"date":44,"type":20},"2026-01-30",{"date":46,"type":20},"2026-09-30",{"name":48,"class":49},"Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100623220","phase-3-evaluation-of-the-anti-plaque-effect-of-a-resveratrol-based-mouthwash-using-a-24-hour-plaque-re-growth-100623220","NCT07393802","Evaluation of the Anti-Plaque Effect of a Resveratrol-Based Mouthwash Using a 24-Hour Plaque Re-Growth","Evaluation of the Anti-Plaque Effect of a Resveratrol-Based Mouthwash Using a 24-Hour Plaque Biofilm Re-Growth Randomized Crossover Clinical Trial","Inclusion Criteria:\n\n* Age between 18 and 30 years\n* Systemically healthy individuals\n* Presence of at least 20 natural teeth\n* Clinically healthy gingiva with no signs of gingivitis or periodontitis\n* No probing depth \\>3 mm\n* No clinical attachment loss\n\nExclusion Criteria:\n\n* Presence of gingivitis or periodontitis\n* Active dental caries requiring treatment\n* History of periodontal therapy within the previous 6 months\n* Use of antibiotics, anti-inflammatory drugs, or antiseptic mouthwashes within the previous 3 months\n* Smoking or tobacco use\n* Pregnancy or lactation\n* Known allergy to any mouthwash components",true,"18 Years","25 Years",{"count":61,"type":20},20,[63],"PHASE3","Dental plaque is a biofilm that accumulates on tooth surfaces and is a primary factor in the development of gingival inflammation. While toothbrushing remains the main method for plaque control, the effectiveness of mechanical oral hygiene depends largely on individual compliance and technique. As a result, mouthwashes are commonly used as adjunctive chemical plaque control agents.\n\nChlorhexidine gluconate is an effective anti-plaque mouthwash, but its use is associated with undesirable effects that may limit patient acceptance. Resveratrol is a naturally derived compound with reported antimicrobial and anti-biofilm properties, suggesting its potential use as an alternative chemical plaque control agent.\n\nThis randomized, double-blind, placebo-controlled, three-period crossover clinical trial aims to evaluate the short-term anti-plaque effect of a resveratrol-based mouthwash by measuring supragingival plaque regrowth over a 24-hour period in periodontally healthy individuals. The effects of the resveratrol-based mouthwash will be compared with 0.12% chlorhexidine (CHX) and a placebo mouthwash under standardized conditions without mechanical oral hygiene",[66,67,30,68],"Mouthwash","Chlorhexidine","Periodontal Health",[70,71,72,73],"Resveratrol","mouthwash","anti-plaque","crossover",{"date":39,"type":42},{"date":76,"type":20},"2026-03",{"date":78,"type":20},"2026-05",{"name":80,"class":49},"University of Baghdad",1]