[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658046":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":35,"studyPopulation":22,"armGroups":36,"interventions":48,"overallOfficials":60,"centralContacts":65,"locations":73,"responsibleParty":86,"collaborators":22,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":22,"enrollmentInfo":98,"targetDuration":22,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":76,"whyStopped":22,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":22},[9,13],{"measure":10,"description":11,"timeFrame":12},"Evaluation of the effectiveness in reducing the bacterial load on the skin of bedridden patients through the use of two different cleaning and washing systems","for three consecutive days, after surgery, we measure skin pH before and after cleaning with swab, to evaluate any variation (acid vs basic). We collect coltural exam before and after cleaning, to evaluate change in bacterial charge.\n\nFinally to measure time for cleaning and satisfaction of the patient","18 months",{"measure":14,"description":15,"timeFrame":16},"Evaluation of effectiveness in reducing the bacterial load on the skin of bedridden patient,. Before and after this procedure we want to measure pH of the skin and coltural skin exam to evaluate difference between groups","This evaluation will be carried out on a daily frequence and will begin on the first day after surgery and for three days","From the first day after surgery until a 30 days follow up",[18],{"measure":19,"description":20,"timeFrame":21},"Analysis of patient comfort levels assessed through a questionnaire on comfort during hygiene procedures. Operational efficiency assessed by the ratio of 'time taken\u002Fresult obtained'","During these three daays a person \"blind\" of method, will ask patient with an interview finalized to determine what patients think about","three days for each patient of the two groups, plus a follow up 30 days afetr surgery",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":26,"primaryPurpose":27,"observationalModel":22,"timePerspective":22,"maskingInfo":28},"RANDOMIZED","PARALLEL","Adult bedridden patients who are potentially critical due to coexisting diseases such they are classified as ASA 3. A total of 164 subjeill be enrolled and randomised in two groups. Skin pH measurement, collection of sample for culture tests are considered","PREVENTION",{"masking":29,"maskingDescription":30,"whoMasked":31},"TRIPLE","Staff using one of the two cleaning and washing systems are not involved in the assessement and measurement",[32,33,34],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","Since bed is recognized as a critical time for the onset of skin superinfections, the study aims to evaluate, by comparison, two different methods of managing bedridden patients using time spent for hygiene, daily skin pH measurement and samples for cilture tests",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Swab washing group, that means we want to use a specific swab for cleaning","ACTIVE_COMPARATOR","Evaluation of the effectiveness in reducing the bacterial load on the skin of bedridden patients . The evaluations will be carried out on a daily basis and will begin on the first day after surgery for 3 consecutive days. Evaluation is comprehensive of pH value before and after cleaning and cultural exam before and after",[42],"Procedure: Swab for cleaning, used as first comparator. For this group we want, during these three days and each day, measure skin pH before and after, Coltural exam before and after and time for cleaning",{"label":44,"type":45,"description":40,"interventionNames":46},"Pre-soaped sponges, using an usual methods for skin cleaning","SHAM_COMPARATOR",[47],"Procedure: sham group with sponge for skin detersion",[49,56],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"PROCEDURE","Swab for cleaning, used as first comparator. For this group we want, during these three days and each day, measure skin pH before and after, Coltural exam before and after and time for cleaning","The method will be the same of the swab arm. The goal is to compare the two groups looking at any differences",[38],[55],"Sponge for cleaning, used as sham comparator",{"type":50,"name":57,"description":58,"armGroupLabels":59,"otherNames":22},"sham group with sponge for skin detersion","Procedure\u002FSurgery: Sponge group: Use of this device for skin detersion, measuring also pH test and coltural examination before and after cleaning Description: we want to compare sponge detersion in bedridden patient, looking at pH test and coltural examination before and after surgery",[44],[61],{"name":62,"affiliation":63,"role":64},"Giorgio Oriani","IRCCS OGSA - Site Istituto San Siro","PRINCIPAL_INVESTIGATOR",[66,71],{"name":67,"role":68,"phone":69,"phoneExt":22,"email":70},"Giorgio Oriani, Physician - Anesthetist","CONTACT","+39335225452","giorgio.oriani@grupposandonato.it",{"name":72,"role":68,"phone":22,"phoneExt":22,"email":22},"Elena Cittera",[74],{"facility":75,"status":76,"city":77,"state":22,"zip":22,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":22},"Istituto Clinico San Siro","RECRUITING","Milan","Italy","IT",{"type":81,"coordinates":82},"Point",[83,84],12.59836,42.78235,{"lat":84,"lon":83},{"type":64,"investigatorFullName":72,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Giorgio Oriani MD","100658046","how-to-prevent-post-surgery-infections-100658046",false,"NCT07848269","How to Prevent Post-surgery Infections","Evaluation of a Bundle of Actions to Prevent Skin Infections","Bundle","Inclusion Criteria:\n\n* Age over 18 -\n* Both sexes\n* ASA III with need of monitoring\n* Major surgery (Hip, Knee- Shoulder-first or revision)\n\nExclusion Criteria:\n\n* Lack of consent\n* Poor cooperation\n* Post-operative delirium\n* Pregnant women","ALL","18 Years",{"count":99,"type":100},164,"ESTIMATED","INTERVENTIONAL",[103],"NA","Evaluation of the effectiveness in reducing the bacterial load on the skin of bedridden opatients through the use of two different cleaning and washing systems (swash bathing gloves vs pre-soaped sponges). The evaluation will be carried out on a daily basis and will begin on the first day after surgery for 3 consecutive days",[106,107],"ASAIII Patients Before Surgery","Bedridden Patients After Surgery",[109,110,111,112],"Skin pH","ASA III","Swab","Sponge","2026-09-23",{"date":115,"type":116},"2026-09-29","ACTUAL",{"date":118,"type":116},"2026-09-09",{"date":120,"type":100},"2027-12-31",{"name":5,"class":6},1]