Evidence map›Paper›PMID 36175092›Full record

ArticleBMJ open2022

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.

Monira El Genedy-Kalyoncu, Alexandra Fastner, Bettina Völzer, Kathrin Raeder, Konrad Neumann, Nils Axel Lahmann, Jan Kottner

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05403762 (Comparison of Two Skin Protection Regimes for the Prevention of Incontinence-associated Dermatitis in Geriatric Care), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05403762 nacompletednot on this map

Comparison of Two Skin Protection Regimes for the Prevention of Incontinence-associated Dermatitis in Geriatric Care: an Exploratory Trial (PID)

TypeinterventionalSponsorCharite University, Berlin, GermanyRan2022 to 2025Enrolled220ConditionsIncontinence-associated DermatitisArmsESENTA™ Skin Barrier Spray (ConvaTec, UK), Hydrophobes Basisgel DAC
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Efficacy of modified isolation in incontinence associated dermatitis.American journal of translational research · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Monira El Genedy-KalyoncuInstitute of Clinical Nursing Science, Charité-Universitätsmedizin Berlin, Berlin, Germany monira.el-genedy@charite.de.ORCID 0000-0001-5947-847X
Alexandra FastnerInstitute of Clinical Nursing Science, Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0002-8718-8397
Bettina VölzerInstitute of Clinical Nursing Science, Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0002-0986-2358
Kathrin RaederDepartment of Geriatrics and Medical Gerontology, Research Group Geriatrics, Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0003-4655-4773
Konrad NeumannDepartment of Biometry and Clinical Epidemiology, Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0001-9482-0971
Nils Axel LahmannDepartment of Geriatrics and Medical Gerontology, Research Group Geriatrics, Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0002-6934-5387
Jan KottnerInstitute of Clinical Nursing Science, Charité-Universitätsmedizin Berlin, Berlin, Germany.ORCID 0000-0003-0750-3818
Charité - Universitätsmedizin Berlin · DEZimmer Biomet (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe 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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: The study received the approval of the ethics committee of Charité-Universitätsmedizin Berlin (EA4/043/22). Results will be disseminated through peer-reviewed open-access journals and international conferences. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT05403762) and German Clinical Trials Register (Deutsches Register Klinischer Studien, or DRKS) (DRKS00028954).

Indexed as

Body FluidsDermatitisAgedFecesHumansIrritantsPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicSkinIrritantsdermatologygeriatric dermatologyurinary incontinences

Identifiers

PMID36175092
PMCPMC9528637
OpenAlexW4298008896

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.