A Open Study to Evaluate the Performance of Dressing on Subject With High Risk of Skin Breakdown

The rational for the study is to add a thin self-adherent dressing on critically ill patients. Evaluate if the dressing might protect the skin for further breakdown.Participants will be followed for the duration of hospital stay, an expected average of 5 days.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dermatology Department

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Provision of written informed consent
Braden total score ≤ 12 at enrolment
Male or female, ≥ 18 at enrolment
No skin- breakdown
Subject or family member is able to understand and comply with the requirements of the study, judged by the investigator

Exclusion criteria

Risk area dosen´t fit the dressing size
Documented skin disease
Kown allergy to any of the components in the dressing
Previous enroled in present study
Subject included in other ongoing clinical investigation

Treatment and study plan

Primary outcomes

Erythema (No/Yes)

Time frame: During 5 days

Measure number of skin breakdown during from enrolment to termination.

Secondary outcomes

Overall Experience of Use of the Dressing

Time frame: During 5 days

Overall experience of use of the dressing rated on a scale from Very Poor, Poor, Good, Very Good, Excellent

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Registry information

Official study title

A Multi-Centre, Post CE Mark, Open Study to Evaluate the Performance of Thin Self-adherent Dressing Coated With a Soft Silicone Layer on Subjects With a High Risk of Skin Breakdown

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: May 17, 2011
Registry last updated: May 9, 2016

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.

Published trials that share one or more normalized conditions with this study.

Completed