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OpenTrials
Completed

NCT Number: NCT07816549

Prospective Explorative Research Study of Comparison of Biomarkers Related to Incontinence Associated Dermatitis (IAD) From Skin Swabs

The aim of this explorative study is to collect information about biomarkers that differentiate skin affected by Incontinence Associated Dermatitis (IAD) from non-affected skin.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nursing home

Mölndal, Sweden

About this study

The findings obtained from this study will be used to develop biosensors that aims to predict the increasing risk of developing IAD and hence be able to prevent the occurrence of IAD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Mentally and physically able to participate in this study.
  • Willing and able to provide written informed consent to participate in this study or, if unable to provide such consent, have a legal representative who is willing and able to provide informed consent on behalf of the participant.
  • Individual with urinary and/or faecal incontinence and using incontinence products at a regular basis.
  • Has an area under incontinence products with IAD, incontinence associated dermatitis that shows any sign(s) of skin irritation e.g., redness, itching, rashes. 1A and 2A according to GLOBIAD categorisation model [Appendix C for detailed description]. 1A is persistent redness without clinical sign of infection and 2A is skin loss without clinical sign of infection.

Exclusion criteria

  • Severe skin breakdown at the investigated area.
  • Individual with skin infection at the investigated area.
  • GLOBIAD 1B and 2B, 1B is persistent redness with clinical signs of infection and 2B is skin loss with clinical sign of infection

Treatment and study plan

Primary outcomes

  1. Identified biomarkers level

    Time frame: One time

Sponsors and collaborators

Lead sponsor

Essity Hygiene and Health AB

Industry

Registry information

Acronym: BioSens

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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