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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

May 16, 2011
September 13, 2011
May 2011
June 2011   (final data collection date for primary outcome measure)
No skin breakdown during the study period [ Time Frame: December 2011 ] [ Designated as safety issue: No ]
No skin breakdown during the study period
Same as current
Complete list of historical versions of study NCT01354899 on ClinicalTrials.gov Archive Site
Not Provided
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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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Critically ill patients at ICU.

Critical Illness
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01354899
WINDOW 01, Window 02
No
Molnlycke Health Care AB
Molnlycke Health Care AB
Not Provided
Principal Investigator: Jan Faergemann, Professor Dermatology Department Sahlgrenska University Gothenburg
Molnlycke Health Care AB
September 2011

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