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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01354899
First received: May 16, 2011
Last updated: September 13, 2011
Last verified: September 2011
  Purpose

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.


Condition
Critical Illness

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Further study details as provided by Molnlycke Health Care AB:

Primary Outcome Measures:
  • No skin breakdown during the study period [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
    No skin breakdown during the study period


Estimated Enrollment: 30
Study Start Date: May 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Critically ill patients at ICU.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354899

Locations
Sweden
Dermatology Department
Gothenburg, Sweden
Sponsors and Collaborators
Molnlycke Health Care AB
Investigators
Principal Investigator: Jan Faergemann, Professor Dermatology Department Sahlgrenska University Gothenburg
  More Information

No publications provided

Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01354899     History of Changes
Other Study ID Numbers: WINDOW 01, Window 02
Study First Received: May 16, 2011
Last Updated: September 13, 2011
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014