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

NCT ID: NCT01354899

Last Updated: 2016-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2011-06-30

Brief 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.

Conditions

Critical Illness

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Faergemann, Professor

Role: PRINCIPAL_INVESTIGATOR

Dermatology Department Sahlgrenska University Gothenburg

Locations

Dermatology Department

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

Window 02

Identifier Type: -

Identifier Source: secondary_id

WINDOW 01

Identifier Type: -

Identifier Source: org_study_id