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

May 16, 2011
April 5, 2016
May 2011
June 2011   (final data collection date for primary outcome measure)
Erythema (No/Yes) [ Time Frame: During 5 days ] [ Designated as safety issue: No ]
Measure number of skin breakdown during from enrolment to termination.
No skin breakdown during the study period [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
No skin breakdown during the study period
Complete list of historical versions of study NCT01354899 on ClinicalTrials.gov Archive Site
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
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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.
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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample
Critically ill patients at ICU.
Critical Illness
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01354899
WINDOW 01, Window 02
No
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Molnlycke Health Care AB
Molnlycke Health Care AB
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Principal Investigator: Jan Faergemann, Professor Dermatology Department Sahlgrenska University Gothenburg
Molnlycke Health Care AB
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP