MedPath

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

Completed
Conditions
Critical Illness
Registration Number
NCT01354899
Lead Sponsor
Molnlycke Health Care AB
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Erythema (No/Yes)During 5 days

Measure number of skin breakdown during from enrolment to termination.

Secondary Outcome Measures
NameTimeMethod
Overall Experience of Use of the DressingDuring 5 days

Overall experience of use of the dressing rated on a scale from Very Poor, Poor, Good, Very Good, Excellent

Trial Locations

Locations (1)

Dermatology Department

🇸🇪

Gothenburg, Sweden

Dermatology Department
🇸🇪Gothenburg, Sweden
© Copyright 2025. All Rights Reserved by MedPath