{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,11]],"date-time":"2026-01-11T01:37:41Z","timestamp":1768095461688,"version":"3.49.0"},"reference-count":44,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2022,9,28]],"date-time":"2022-09-28T00:00:00Z","timestamp":1664323200000},"content-version":"unspecified","delay-in-days":27,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002347","name":"Federal Ministry of Education and Research","doi-asserted-by":"crossref","award":["01KG2020"],"award-info":[{"award-number":["01KG2020"]}],"id":[{"id":"10.13039\/501100002347","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,9,7]]},"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The majority of aged long-term care receivers and patients in geriatric acute care are affected by some form of incontinence. These individuals are at risk of developing incontinence-associated dermatitis (IAD), a common type of irritant contact dermatitis caused by repeated and prolonged direct contact of the skin with urine and stool. The prevalence of IAD in these settings is high. Preventive measures include mild skin cleansing and the application of skin protecting leave-on products. Available evidence is weak regarding the comparative performance of different skin protection strategies and products due to a lack of confirmatory trials using relevant comparators and endpoints. Therefore, the overall aim of this exploratory trial is to compare the effects of three skin protection strategies to estimate effect sizes of the recently published core outcomes in IAD research.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>A pragmatic three-arm, assessor-blinded, randomised controlled, exploratory trial with parallel group design will be performed, comparing film-forming and lipophilic skin protecting leave-on products for IAD prevention with standard incontinence care alone. The trial will be conducted in geriatric nursing homes and geriatric acute care settings in the federal state of Berlin, Germany. A total of n=210 participants being incontinent of urine and stool will be included. Outcomes include IAD incidence, erythema, erosion, maceration, IAD-related pain, patient satisfaction, safety, feasibility and compliance. IAD incidence of the control and intervention groups will be compared to estimate effect sizes, and the procedural feasibility of the intervention will be tested to plan a possible subsequent confirmatory randomised controlled trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study received the approval of the ethics committee of Charit\u00e9\u2013Universit\u00e4tsmedizin Berlin (EA4\/043\/22). Results will be disseminated through peer-reviewed open-access journals and international conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05403762\">NCT05403762<\/jats:ext-link>\n                      ) and German Clinical Trials Register (Deutsches Register Klinischer Studien, or DRKS) (DRKS00028954).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-065909","type":"journal-article","created":{"date-parts":[[2022,9,29]],"date-time":"2022-09-29T11:46:56Z","timestamp":1664452016000},"page":"e065909","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Comparison of two skin protection regimes for the Prevention of Incontinence-associated Dermatitis in geriatric care (PID): a study protocol for an exploratory randomised controlled pragmatic trial"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct05403762","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03298113","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05403762","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5947-847X","authenticated-orcid":false,"given":"Monira","family":"El Genedy-Kalyoncu","sequence":"first","affiliation":[{"name":"Institute of Clinical Nursing Science, Charit\u00e9\u2013Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8718-8397","authenticated-orcid":false,"given":"Alexandra","family":"Fastner","sequence":"additional","affiliation":[{"name":"Institute of Clinical Nursing Science, Charit\u00e9\u2013Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0986-2358","authenticated-orcid":false,"given":"Bettina","family":"V\u00f6lzer","sequence":"additional","affiliation":[{"name":"Institute of Clinical Nursing Science, Charit\u00e9\u2013Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4655-4773","authenticated-orcid":false,"given":"Kathrin","family":"Raeder","sequence":"additional","affiliation":[{"name":"Department of Geriatrics and Medical Gerontology, Research Group Geriatrics, Charit\u00e9\u2013Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9482-0971","authenticated-orcid":false,"given":"Konrad","family":"Neumann","sequence":"additional","affiliation":[{"name":"Department of Biometry and Clinical Epidemiology, Charit\u00e9\u2013Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6934-5387","authenticated-orcid":false,"given":"Nils Axel","family":"Lahmann","sequence":"additional","affiliation":[{"name":"Department of Geriatrics and Medical Gerontology, Research Group Geriatrics, Charit\u00e9\u2013Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0750-3818","authenticated-orcid":false,"given":"Jan","family":"Kottner","sequence":"additional","affiliation":[{"name":"Institute of Clinical Nursing Science, Charit\u00e9\u2013Universit\u00e4tsmedizin Berlin, Berlin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2022,9,29]]},"reference":[{"key":"2025121400004469000_12.9.e065909.1","doi-asserted-by":"publisher","DOI":"10.1097\/WON.0b013e31823fe246"},{"key":"2025121400004469000_12.9.e065909.2","doi-asserted-by":"publisher","DOI":"10.1097\/00152192-200701000-00008"},{"key":"2025121400004469000_12.9.e065909.3","doi-asserted-by":"crossref","first-page":"63","DOI":"10.1097\/WON.0000000000000390","article-title":"Incontinence-Associated dermatitis, characteristics and relationship to pressure injury: a multisite epidemiologic analysis","volume":"45","author":"Gray","year":"2018","journal-title":"J Wound Ostomy Continence Nurs"},{"key":"2025121400004469000_12.9.e065909.4","unstructured":"Van Damme N , Vanryckeghem E , Verhaeghe S . Incontinence-associated dermatitis in elderly: a qualitative phenomenological study on patient experiences. Annual Conference of the European Pressure Ulcer Advisory Panel, Gent, Belgium, 2015."},{"key":"2025121400004469000_12.9.e065909.5","first-page":"717","article-title":"Incontinence-associated dermatitis and pressure ulcers in geriatric patients","volume":"150","author":"Kottner","year":"2015","journal-title":"G Ital Dermatol Venereol"},{"key":"2025121400004469000_12.9.e065909.6","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1007\/s40266-017-0507-1","article-title":"Incontinence-Associated dermatitis: pathogenesis, contributing factors, prevention and management options","volume":"35","author":"Beele","year":"2018","journal-title":"Drugs Aging"},{"key":"2025121400004469000_12.9.e065909.7","unstructured":"Beeckman D . Incontinene-associated dermatitis: moving prevention forward. Proceedings of the global IAD expert panel, London: Wounds international, 2015."},{"key":"2025121400004469000_12.9.e065909.8","doi-asserted-by":"crossref","first-page":"801","DOI":"10.1111\/iwj.12699","article-title":"Independent risk factors for the development of skin erosion due to incontinence (incontinence-associated dermatitis category 2) in nursing home residents: results from a multivariate binary regression analysis","volume":"14","author":"Van Damme","year":"2017","journal-title":"Int Wound J"},{"key":"2025121400004469000_12.9.e065909.9","doi-asserted-by":"publisher","DOI":"10.1097\/00006199-200607000-00004"},{"key":"2025121400004469000_12.9.e065909.10","doi-asserted-by":"crossref","first-page":"2490","DOI":"10.1111\/j.1365-2702.2007.02055.x","article-title":"Prevalence and incidence of urinary incontinence of Swiss nursing home residents at admission and after six, 12 and 24\u2003months","volume":"17","author":"Saxer","year":"2008","journal-title":"J Clin Nurs"},{"key":"2025121400004469000_12.9.e065909.11","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1155\/2011\/671302","article-title":"Urinary incontinence in hospitalised elderly patients: do nurses recognise and manage the problem?","volume":"2011","author":"Z\u00fcrcher","year":"2011","journal-title":"Nurs Res Pract"},{"key":"2025121400004469000_12.9.e065909.12","first-page":"248","article-title":"Incontinence-associated dermatitis (IAD): aetiology, pathogenesis, risk and epidemiology","volume":"10","author":"Kottner","year":"2016","journal-title":"Wund Management"},{"key":"2025121400004469000_12.9.e065909.13","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2017-018283","article-title":"Prevalence and associated factors of skin diseases in aged nursing home residents: a multicentre prevalence study","volume":"7","author":"Hahnel","year":"2017","journal-title":"BMJ Open"},{"key":"2025121400004469000_12.9.e065909.14","first-page":"329","article-title":"Skin care practice in German nursing homes: a German-wide cross-sectional study","volume":"11","author":"Kottner","year":"2013","journal-title":"J Dtsch Dermatol Ges"},{"key":"2025121400004469000_12.9.e065909.15","article-title":"Hautpflege Im Krankenhaus: eine deskriptive studie","volume":"69","author":"Lichterfeld","year":"2016","journal-title":"Pflegezeitschrift"},{"key":"2025121400004469000_12.9.e065909.16","doi-asserted-by":"crossref","DOI":"10.1016\/j.ijnurstu.2019.103509","article-title":"Maintaining skin integrity in the aged: a systematic review","volume":"103","author":"Lichterfeld-Kottner","year":"2020","journal-title":"Int J Nurs Stud"},{"key":"2025121400004469000_12.9.e065909.17","doi-asserted-by":"crossref","first-page":"154","DOI":"10.1159\/000090352","article-title":"Anti-Irritants: myth or reality? an overview","volume":"3","author":"Ford","year":"2004","journal-title":"Exog Dermatol"},{"key":"2025121400004469000_12.9.e065909.18","doi-asserted-by":"publisher","DOI":"10.1007\/s00420-002-0419-0"},{"key":"2025121400004469000_12.9.e065909.19","first-page":"594","article-title":"S1 guideline on occupational skin products: protective creams, skin cleansers, skin care products (ICD 10: L23, L24) - short version","volume":"13","author":"Fartasch","year":"2015","journal-title":"J Dtsch Dermatol Ges"},{"key":"2025121400004469000_12.9.e065909.20","doi-asserted-by":"crossref","first-page":"494","DOI":"10.1097\/01.ASW.0000525627.54569.da","article-title":"Management of Moisture-Associated skin damage: a scoping review","volume":"30","author":"Woo","year":"2017","journal-title":"Adv Skin Wound Care"},{"key":"2025121400004469000_12.9.e065909.21","doi-asserted-by":"crossref","first-page":"1605","DOI":"10.1111\/jan.13562","article-title":"Core outcome domains in incontinence-associated dermatitis research","volume":"74","author":"Van den Bussche","year":"2018","journal-title":"J Adv Nurs"},{"key":"2025121400004469000_12.9.e065909.22","doi-asserted-by":"crossref","first-page":"64","DOI":"10.1186\/s40814-016-0105-8","article-title":"Consort 2010 statement: extension to randomised pilot and feasibility trials","volume":"2","author":"Eldridge","year":"2016","journal-title":"Pilot Feasibility Stud"},{"key":"2025121400004469000_12.9.e065909.23","doi-asserted-by":"crossref","first-page":"1331","DOI":"10.1111\/bjd.16327","article-title":"Towards an international language for incontinence-associated dermatitis (IAD): design and evaluation of psychometric properties of the Ghent global IAD categorization tool (GLOBIAD) in 30 countries","volume":"178","author":"Beeckman","year":"2018","journal-title":"Br J Dermatol"},{"key":"2025121400004469000_12.9.e065909.24","doi-asserted-by":"publisher","DOI":"10.1111\/j.1749-6632.1994.tb12816.x"},{"key":"2025121400004469000_12.9.e065909.25","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.g1687"},{"key":"2025121400004469000_12.9.e065909.26","doi-asserted-by":"crossref","first-page":"527","DOI":"10.1097\/WON.0b013e3181edac3e","article-title":"The incontinence-associated dermatitis and its severity instrument: development and validation","volume":"37","author":"Borchert","year":"2010","journal-title":"J Wound Ostomy Continence Nurs"},{"key":"2025121400004469000_12.9.e065909.27","doi-asserted-by":"crossref","first-page":"1351","DOI":"10.1111\/bjd.14419","article-title":"The 2016 International League of Dermatological Societies\u2019 revised glossary for the description of cutaneous lesions","volume":"174","author":"Nast","year":"2016","journal-title":"Br J Dermatol"},{"key":"2025121400004469000_12.9.e065909.28","doi-asserted-by":"crossref","first-page":"159","DOI":"10.12968\/jowc.2017.26.4.159","article-title":"Identifying, managing and preventing skin maceration: a rapid review of the clinical evidence","volume":"26","author":"Whitehead","year":"2017","journal-title":"J Wound Care"},{"key":"2025121400004469000_12.9.e065909.29","unstructured":"Courage and Khazaka electronic GmbH . Mexameter\u00ae Mx 18, 2021. Available: https: \/\/www. courage-khazaka.de\/de\/16-wissenschaftliche-produkte\/alle-produkte\/92-mexameter-d [Accessed 17 Dec 2021]."},{"key":"2025121400004469000_12.9.e065909.30","doi-asserted-by":"crossref","first-page":"269","DOI":"10.1016\/j.jtv.2020.06.007","article-title":"Reliability and agreement of skin barrier measurements in a geriatric care setting","volume":"29","author":"Elban","year":"2020","journal-title":"J Tissue Viability"},{"key":"2025121400004469000_12.9.e065909.31","doi-asserted-by":"crossref","first-page":"716","DOI":"10.1111\/iwj.13574","article-title":"Reliability and agreement of instrumental skin barrier measurements in clinical pressure ulcer prevention research","volume":"18","author":"Kottner","year":"2021","journal-title":"Int Wound J"},{"key":"2025121400004469000_12.9.e065909.32","first-page":"61","article-title":"Functional evaluation: the BARTHEL index","volume":"14","author":"Mahoney","year":"1965","journal-title":"Md State Med J"},{"key":"2025121400004469000_12.9.e065909.33","doi-asserted-by":"publisher","DOI":"10.1016\/0022-3956(75)90026-6"},{"key":"2025121400004469000_12.9.e065909.34","doi-asserted-by":"publisher","DOI":"10.1007\/s00482-006-0490-7"},{"key":"2025121400004469000_12.9.e065909.35","doi-asserted-by":"crossref","first-page":"742","DOI":"10.1097\/j.pain.0000000000001430","article-title":"Pain assessment in advanced dementia. validity of the German PAINAD\u2014a prospective double-blind randomised placebo-controlled trial","volume":"160","author":"Lukas","year":"2019","journal-title":"Pain"},{"key":"2025121400004469000_12.9.e065909.36","doi-asserted-by":"crossref","first-page":"155","DOI":"10.1159\/000487403","article-title":"Effect of fluid intake on hydration status and skin barrier characteristics in geriatric patients: an explorative study","volume":"31","author":"Akdeniz","year":"2018","journal-title":"Skin Pharmacol Physiol"},{"key":"2025121400004469000_12.9.e065909.37","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-15-264"},{"key":"2025121400004469000_12.9.e065909.38","doi-asserted-by":"crossref","first-page":"32","DOI":"10.1186\/s40814-015-0026-y","article-title":"Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers","volume":"1","author":"O'Cathain","year":"2015","journal-title":"Pilot Feasibility Stud"},{"key":"2025121400004469000_12.9.e065909.39","doi-asserted-by":"crossref","first-page":"165","DOI":"10.1097\/WON.0000000000000313","article-title":"Incidence and predictors of Incontinence-Associated skin damage in nursing home residents with new-onset incontinence","volume":"44","author":"Bliss","year":"2017","journal-title":"J Wound Ostomy Continence Nurs"},{"key":"2025121400004469000_12.9.e065909.40","doi-asserted-by":"crossref","first-page":"e9","DOI":"10.1016\/S0140-6736(15)01279-9","article-title":"Sharing clinical trial data: a proposal from the International Committee of medical Journal editors","volume":"387","author":"Taichman","year":"2016","journal-title":"Lancet"},{"key":"2025121400004469000_12.9.e065909.41","article-title":"Interventions for preventing and treating incontinence-associated dermatitis in adults","volume":"11","author":"Beeckman","year":"2016","journal-title":"Cochrane Database Syst Rev"},{"key":"2025121400004469000_12.9.e065909.42","doi-asserted-by":"crossref","first-page":"110","DOI":"10.12968\/jowc.2019.28.2.110","article-title":"Technological features of advanced skin protectants and an examination of the evidence base","volume":"28","author":"Woo","year":"2019","journal-title":"J Wound Care"},{"key":"2025121400004469000_12.9.e065909.43","doi-asserted-by":"crossref","unstructured":"Garbe C , Reimann H . Dermatologische Rezepturen. 3rd ed. Stuttgart: Thieme, 2017.","DOI":"10.1055\/b-004-132236"},{"key":"2025121400004469000_12.9.e065909.44","unstructured":"United States National Library of Medicine . Comparative study to assess an advanced skin protectant in the management of Incontinence-associated dermatitis; 2019."}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2022-065909","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T08:00:57Z","timestamp":1765699257000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2022-065909"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,9]]},"references-count":44,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2022,9,29]]},"published-print":{"date-parts":[[2022,9]]}},"alternative-id":["10.1136\/bmjopen-2022-065909"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2022-065909","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,9]]}}}