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NCT01354899 Clinical Trial

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

Critical Illness Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01354899
Other study ID # WINDOW 01
Secondary ID Window 02
Status Completed
Phase N/A
First received May 16, 2011
Last updated September 13, 2011
Start date May 2011
Est. completion date June 2011

Study information
Verified date September 2011
Source Molnlycke Health Care AB
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Dermatology Department Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary No skin breakdown during the study period No skin breakdown during the study period December 2011 No
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