N/A
Completed N=50
Pressure Injury Prevention in the ICU With Multi-Layer Foam Dressings
Pressure Incidence Prevention
Source: ClinicalTrials.gov NCT02962882 ↗
Enrolled (actual)
50
Serious AEs
14.0%
Results posted
Mar 2018
Primary outcomePrimary: User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication — 1; 1; 6; 0 Dressing changes evaluated
Summary
A Multi-Centre, Open, Non-controlled, Clinical Investigation to Evaluate the User Friendliness and Wear Time of Multi-layer Foam Dressings With Safetac® for Pressure Injury Prevention in the Intensive Care Unit
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY User Friendliness of Both Sacrum and Heel (Left & Right) Dressings: Comfort, Conformability, Acceptability, the Handling at Application and Ease of Inspection of the Dressings as Well as Reapplication |
6; 6; 16; 29; 10; 22 | — |
| SECONDARY Wear Time (Days) for First Dressing |
2; 2; 23; 23; 17; 19 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is at risk for developing a pressure injury to the heels and/or sacrum
- Aged ≥ 18 years
- Patient or his/her legal representative is able to understand and voluntarily sign the informed consent
- Estimated treatment period in ICU for patient at least 4-6 days
Exclusion Criteria
- Patient has a pressure injury or blistering on sacrum and/or heels
- Patient with known or suspected sensitivity to any of the components of the products being evaluated
- Patient included in other clinical investigations at present or within the last 30 days
Data sourced from ClinicalTrials.gov (NCT02962882). 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. Informational only — not medical advice.