N/A
N=24
A Open Study to Evaluate the Performance of Dressing on Subject With High Risk of Skin Breakdown
Critical Illness
Bottom Line
View on ClinicalTrials.gov: NCT01354899 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
May 2016
Primary outcome: Primary: Erythema (No/Yes) — 21; 3 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Molnlycke Health Care AB
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Erythema (No/Yes) |
21; 3 | — |
| SECONDARY Overall Experience of Use of the Dressing |
1; 3; 10; 9; 1 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01354899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.