[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645079":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":24,"locations":30,"responsibleParty":49,"collaborators":11,"id":51,"slug":11,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":11,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":11,"enrollmentInfo":59,"targetDuration":11,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":11,"overallStatus":69,"whyStopped":11,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Laboratorios Ozoaqua","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ozoaqua protocol treament + standard postoperative care","EXPERIMENTAL",null,[13],"Other: Ozonated product-based protocol for scar hygiene and care",{"label":15,"type":16,"description":17,"interventionNames":11},"Standard postoperative care","NO_INTERVENTION","Physiological saline solution and aqueous chlorhexidine",[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"OTHER","Ozonated product-based protocol for scar hygiene and care","Ozonated oil soap and ozonated oil, added to standard postoperative care",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"Juan Gabriel Agüera Santos","CONTACT","+34 623 02 25 86","juan.aguera@bioithas.com",[31],{"facility":32,"status":11,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Clínica Universidad de Navarra","Pamplona","Navarre","31008","Spain","ES",{"type":39,"coordinates":40},"Point",[41,42],-1.64323,42.81687,{"lat":42,"lon":41},[45],{"name":46,"role":27,"phone":47,"phoneExt":11,"email":48},"Nuria Pretel Garrido","+34 658 34 59 91","npretelgar@unav.es",{"type":50,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100645079",false,"NCT07678372","Management of Abdominal Post-surgical Scar With Ozoaqua Versus Standard Care","Prospective, Randomized, Evaluator-blinded Clinical Study to Compare a Post-surgical Scar Care Protocol Using OzoAqua Products Versus Standard Care in Open Abdominal Surgery.","Inclusion Criteria:\n\n* Age ≥18 years\n* Scheduled open abdominal surgery\n* Primary wound closure\n* Assessable linear abdominal scar\n* Signed informed consent\n* Ability to complete 3-month follow-up\n\nExclusion Criteria:\n\n* Known allergy to treatment components\n* Active infection or significant dehiscence in the immediate postoperative period\n* Planned use of specific scar treatments -silicone products, laser therapy, local corticosteroids- except as clinical rescue treatment\n* Inability to complete follow-up\n* Participation in another study that may interfere with wound healing","FEMALE","18 Years",{"count":60,"type":61},144,"ESTIMATED","INTERVENTIONAL",[64],"NA","A prospective, randomized clinical study with a blinded evaluator to compare a post-surgical abdominal scar care protocol using Ozoaqua products versus standard care in patients undergoing open abdominal surgery. The primary objective is to assess whether the use of Ozoaqua, initiated in the immediate postoperative period according to wound evolution, improves abdominal scar quality at 3 months compared with usual care.\n\nThe proposed design is an initial single-center study at the Clínica Universidad de Navarra, with 1:1 random allocation to two parallel arms: an intervention group receiving standard care plus Ozoaqua ozonated soap and oil, and a control group receiving standard care only. The primary scar assessment will be performed by a blinded evaluator, while treatment will be open-label due to the nature of the topical intervention.\n\nThe target population consists of adult patients undergoing scheduled open abdominal surgery, with primary wound closure and an assessable linear abdominal scar. Follow-up will be integrated into routine clinical care, including an in-hospital phase during the first postoperative days and outpatient visits at approximately 2 weeks, 1 month and 3 months, with the latter being the main study visit.\n\nThe primary endpoint will be scar quality at 3 months, assessed using the POSAS scale, particularly the blinded observer score. Secondary endpoints will include the patient POSAS score, scar evolution, wound complications, pain, pruritus, satisfaction, cutaneous adverse events, rescue treatments and adherence.",[67,68],"Wound Healing","Post-surgical Abdominal Scar After Open Abdominal Surgery","NOT_YET_RECRUITING","2026-06-25",{"date":72,"type":73},"2026-07-01","ACTUAL",{"date":75,"type":61},"2026-07-06",{"date":77,"type":61},"2027-07-06",{"name":5,"class":6},1]