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

Not Applicable

Completed

• Conditions: Pressure Incidence Prevention

• Registration Number: NCT02962882
• Lead Sponsor: Molnlycke Health Care AB

Brief 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.

Study Timeline

• Study First Submitted: 2016-08-23
• Study Start: 2016-09-09
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-15
• Primary Completion: 2016-11-21
• Study Completion: 2017-05-04
• Results First Submitted: 2018-01-16
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-22
• Last Update Submitted: 2018-03-22
• Results First Posted: 2018-03-26
• Last Update Posted: 2018-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	4-6 days	User friendliness judged by site staff, with the following variables; How do you prefer this dressing to your current dressing?; \*NOTE: Since subjects typically left the ICU earlier than expected (the study protocol stipulated that the test dressing should be left in place for 3 days or longer, however typically the subjects left the ICU department after one day), not all subjects completed the full study period/all study visits.; Furthermore, since not all assessment visits were completed for each subject or a dressing change was not required, the total number of all visits exceeds the total number for each variable. This was because the subject did not undergo a dressing application/removal or that the question was not relevant at a given visit (some questions were only relevant for dressing applications, some questions were only relevant for dressing removals or only relevant for dressing inspections).

Secondary Outcome Measures

Name	Time	Method
Wear Time (Days) for First Dressing	4-6 days	Maximum length of wear time/stay on ability of dressings in ICU.

Trial Locations

Locations (2)

Anmed Health; 🇺🇸 Anderson, South Carolina, United States

Roper Hospital; 🇺🇸 Charleston, South Carolina, United States