Pressure Injury Prevention in the ICU With Multi-Layer Foam Dressings (PUP16_01)

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

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

Study Overview

• Status: Completed
• Conditions: Pressure Incidence Prevention
• Intervention / Treatment: Device: Mepilex Border

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • AnMed Health
    • Charleston, South Carolina, United States, 29401
      • Roper Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A. Mepilex Border Sacrum (Safetac); A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the sacrum area at pressure points in patients in the ICU, prone to get pressure injuries (PI).	Device: Mepilex Border; Multi-layer Foam Dressings
Experimental: B. Mepilex Border Heel (Safetac); A dressing that is a flexible, self-adherent, profylactic, absorbent pad in three layers to be used on the heels (on both left and right heels), in patients in the ICU, prone to get pressure injuries (PI).	Device: Mepilex Border; Multi-layer Foam Dressings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	User friendliness judged by site staff, with the following variables; Ability to stay in place Facilitation of inspection Ease of reapplication Conformability to the body Overall impression of 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).	4-6 days
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	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).	4-6 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Kelli Potter, BSN, RN, AnMed Health Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2016
• Primary Completion (Actual): November 21, 2016
• Study Completion (Actual): May 4, 2017

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: November 9, 2016
• First Posted (Estimate): November 15, 2016

Study Record Updates

• Last Update Posted (Actual): March 26, 2018
• Last Update Submitted That Met QC Criteria: March 22, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Crush Injuries
• Other Study ID Numbers: PUP16_01