[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648323":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":38,"studyPopulation":39,"armGroups":40,"interventions":35,"overallOfficials":44,"centralContacts":48,"locations":56,"responsibleParty":74,"collaborators":35,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":35,"enrollmentInfo":86,"targetDuration":35,"studyType":89,"phases":35,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":58,"whyStopped":35,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Salts Healthcare","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":30},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Assessment description of skin microbial composition of peristomal and non-peristomal skin","Each participant will provide four skin swab samples for microbiome profiling: two swabs from the peristomal (experimental) test site area and two swabs from the non-peristomal (control) test site area, on the opposite side of the abdomen. To Identify microbial species, present in peristomal and non-peristomal area using Metagenomic Shotgun Sequencing","Study appointment (1 hour)",{"measure":14,"description":15,"timeFrame":16},"Assessment of skin barrier chemical composition including water (mass-%), ceramides & fatty acids urea, lactate, protein, natural moisturising factors (NMF) and stratum corneum (SC) thickness of peristomal and non-peristomal skin","6 High Wavenumber profiles of water (mass%) and SC thickness (Microns) and 6 Fingerprint profiles of ceramides \\& fatty acids urea, lactate, protein and natural moisturising factors (NMF) from peristomal skin (experimental) test site area and non-peristomal (control) skin test site area, using the Raman spectrometer","Study Appointment (1 hour)",{"measure":18,"description":19,"timeFrame":16},"Biophysical skin properties including Transepidermis water loss (TEWL), redness and skin colour, elasticity, sebum and pH of peristomal and non-peristomal skin","Measurement of Transepidermal water loss (TEWL) with Tewameter, skin colour (melanin) and skin redness (erythema) with Mexameter, elasticity and firmness with Cutometer, sebum level with Subumeter and pH with pH Meter from peristomal area (experimental) skin test and non-peristomal (control) skin test area",[21,24,27],{"measure":22,"description":23,"timeFrame":16},"Compare microbiota analysis of each peristomal skin stoma type (Colostomy, Ileostomy and Urostomy)","Compare matched peristomal skin microbiomes within each stoma type. Explore associations between microbiome profiles and metadata (age, gender, ethnicity, stoma type, duration of stoma etc.)",{"measure":25,"description":26,"timeFrame":16},"Compare skin barrier chemical composition including water (mass-%), ceramides & fatty acids urea, lactate, protein, natural moisturising factors (NMF) and stratum corneum (SC) thickness of each stoma type peristomal skin","Compare High Wavenumber profiles of water (mass%) and SC thickness (Microns) and Fingerprint profile of ceramides \\& fatty acids urea, lactate, protein and natural moisturising factors (NMF) from each stoma type (Colostomy, Ileostomy and Urostomy) peristomal skin (experimental) test site area, using Skin Tools Data Analysis Software",{"measure":28,"description":29,"timeFrame":16},"Compare biophysical skin properties including Transepidermis water loss (TEWL), redness and skin colour, elasticity, sebum and pH of stoma type (Colostomy, Ileostomy and Urostomy) peristomal skin","Biophysical skin property testing, Transepidermis water loss (TEWL), redness and skin colour, elasticity, sebum and pH from each stoma type (Colostomy, Ileostomy and Urostomy) peristomal skin.",[31],{"measure":32,"description":33,"timeFrame":16},"Correlation between peristomal skin barrier characterisation and stoma type\u002Ffunction and management","Participants will be asked specific stoma questions to capture responses for stoma type\u002Ffunction and management questions. To identify the following:\n\n* Stoma type\u002Ffunction\n* Stoma products\n* Peristomal skin condition\n* Stoma leakage frequency\n* Stoma appliance changes\n* Stoma accessory usage",{"allocation":35,"interventionModel":35,"interventionModelDescription":35,"primaryPurpose":35,"observationalModel":36,"timePerspective":37,"maskingInfo":35},null,"COHORT","CROSS_SECTIONAL","Healthy peristomal skin is vital, not only for stoma bag adherence and the prevention of leakages but for the stability to the skin barrier function. Peristomal skin refers to area surrounding a stoma and skin under the stoma bag adhesive. There is a lack of information and understanding on peristomal skin health and its skin barrier qualities. The study aims to gather data on peristomal and non-peristomal skin barrier characterisation in people living with a stoma. Participants enrolled in the study will undertake the following skin testing procedures:\n\n* Microbiome skin swabbing of peristomal and non-peristomal skin area\n* Skin profiles with Raman Spectrometer of the peristomal and non-peristomal skin\n* Biophysical skin property testing (skin damage, skin colour, redness, elasticity, sebum and pH) of the peristomal and non-peristomal skin","The study population will be recruited from Birmingham UK and the surrounding areas (up to a distance of 150 miles)",[41],{"label":42,"type":35,"description":43,"interventionNames":35},"People Living with a Stoma","Colostomy, Ileostomy, Urostomy",[45],{"name":46,"affiliation":5,"role":47},"Mireille Hamson","PRINCIPAL_INVESTIGATOR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":35,"email":53},"Samantha Jarvis","CONTACT","01213332015","samantha.jarvis@salts.co.uk",{"name":46,"role":51,"phone":35,"phoneExt":35,"email":55},"mireille.hamson@salts.co.uk",[57],{"facility":5,"status":58,"city":59,"state":35,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Birmingham","B7 4AA","United Kingdom","UK",{"type":64,"coordinates":65},"Point",[66,67],-1.89983,52.48142,{"lat":67,"lon":66},[70,71,73],{"name":50,"role":51,"phone":52,"phoneExt":35,"email":53},{"name":46,"role":51,"phone":72,"phoneExt":35,"email":55},"07827997423",{"name":46,"role":47,"phone":35,"phoneExt":35,"email":35},{"type":75,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100648323","exploratory-study-of-peristomal-and-non-peristomal-skin-barrier-characteristics-in-people-with-a-stoma-100648323",false,"NCT07719309","Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma","An Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characterisation in People Living With a Stoma.","Stoma Imprint","Inclusion Criteria:\n\n* Adult 18 years or over\n* Have a stoma (colostomy, ileostomy or urostomy)\n* Have healthy peristomal skin\n* Have the ability to provide informed consent\n* Are independently mobile\n* Can stop using any stoma paste, cream, sprays or lotions on peristomal skin 1 day (24hrs) prior to the study appointment\n* Are independent with stoma care management\n* Are able to attend study appointment in Birmingham, UK\n\nExclusion Criteria:\n\n* Have a current skin condition, such as eczema, psoriasis, or infection around the skin test site areas\n* Have bleeding or broken peristomal skin\n* Are currently taking any of the following medications: steroids, nicotine patches, acne medication (e.g., Accutane), any medication know to affect the properties of the skin\n* Use patches on your abdomen, such as HRT patches\n* Are receiving or have had radiotherapy or chemotherapy in the last 2 months\n* Are taking or have had antibiotic treatment in the last 4 weeks\n* Are currently receiving any stoma care treatment under a stoma care nurse specialist\n* Have tattoos in the skin test site areas\n* Are pregnant\n* Have excessive hair on your abdomen\n* Have participated in another skin testing study within the last 8 weeks","ALL","18 Years",{"count":87,"type":88},108,"ESTIMATED","OBSERVATIONAL","The purpose of this exploratory study is to obtain preliminary data on peristomal and non-peristomal skin barrier characterisation in people living with a stoma. The main questions it aims to answer are:\n\n* Is there a difference\u002Fsimilarity in skin barrier characterisation of peristomal and non-peristomal skin in people living with a stoma?\n* Is there a difference\u002Fsimilarity in peristomal skin barrier function of different stoma types (colostomy, ileostomy and urostomy)?\n* Does a stoma type\u002Ffunction, influence skin barrier characterisation of peristomal skin?\n\nParticipants will:\n\n* Attend a 1-hour study appointment\n* Undergo non-invasive skin procedures",[92,93,94],"Colostomy - Stoma","Ileostomy - Stoma","Urostomy",[96,97,42,98,99],"Peristomal skin","Skin Barrier Characterisation","Exploratory Study","Peristomal Skin Health","2026-10-08",{"date":102,"type":103},"2026-10-09","ACTUAL",{"date":105,"type":88},"2026-09",{"date":107,"type":88},"2028-05",{"name":5,"class":6},1]