N/A N=50 Prevention

Pressure Injury Prevention in the ICU With Multi-Layer Foam Dressings

Pressure Incidence Prevention

Bottom Line

View on ClinicalTrials.gov: NCT02962882 ↗

Enrolled (actual)

Serious AEs

14.0%

Results posted

Mar 2018

Primary outcome: 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 — 1; 1; 6; 0 Dressing changes evaluated

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Mepilex Border (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Molnlycke Health Care AB
Primary completion: Nov 2016

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	—
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	—

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

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

View full record on ClinicalTrials.gov →

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.