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: April 5, 2016
Last verified: April 2016
  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:
  • Erythema (No/Yes) [ Time Frame: During 5 days ] [ Designated as safety issue: No ]
    Measure number of skin breakdown during from enrolment to termination.


Secondary Outcome Measures:
  • Overall Experience of Use of the Dressing [ Time Frame: During 5 days ] [ Designated as safety issue: No ]
    Overall experience of use of the dressing rated on a scale from Very Poor, Poor, Good, Very Good, Excellent


Enrollment: 24
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Results First Received: February 25, 2016
Last Updated: April 5, 2016
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2016