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

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Dermatology department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Critically ill patients at ICU.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erythema (No/Yes)	Measure number of skin breakdown during from enrolment to termination.	During 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Experience of Use of the Dressing	Overall experience of use of the dressing rated on a scale from Very Poor, Poor, Good, Very Good, Excellent	During 5 days

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Jan Faergemann, Professor, Dermatology Department Sahlgrenska University Gothenburg

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 16, 2011
• First Posted (Estimate): May 17, 2011

Study Record Updates

• Last Update Posted (Estimate): May 9, 2016
• Last Update Submitted That Met QC Criteria: April 5, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: WINDOW 01; Window 02