NCT02962882

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This was a multi-centre, open, non-comparative, prospective, clinical investigation involving 50 enrolled subjects using competitive enrolment at two sites in the United States of America (USA). The study was conducted on subjects at risk of developing PIs according to investigators' judgment and facility protocol being treated in ICUs. The target subjects were male and female, 18 years and above, with an expected hospital stay of 4-6 days. An evaluable subject was defined as a subject that was enrolled and had data for at least one visit after the baseline visit. There were two parts to the study: Part A: Mepilex Border/Protect Sacrum; Part B: Mepilex Border/Protect Heel (on both left and right heels), used within intended use and according to IFU.

Conditions

• Pressure Incidence Prevention

Interventions

Type	Name	Description
DEVICE	Mepilex Border	Multi-layer Foam Dressings

Timeline

• Start date: 2016-09-09
• Primary completion: 2016-11-21
• Completion: 2017-05-04
• First posted: 2016-11-15
• Last updated: 2018-03-26
• Results posted: 2018-03-26

Locations

2 sites across 1 country: United States