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

Pressure Incidence Prevention Clinical Trial

— PUP16_01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02962882
• Other study ID #: PUP16_01
• Status: Completed
• Phase: N/A
• First received: August 23, 2016
• Last updated: March 22, 2018
• Start date: September 9, 2016
• Est. completion date: May 4, 2017

Study information

• Verified date: March 2018
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 4, 2017
• Est. primary completion date: November 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crush Injuries
• Pressure Incidence Prevention

Intervention

Device:
• Mepilex Border
Multi-layer Foam Dressings

Locations

Country	Name	City	State
United States	Anmed Health	Anderson	South Carolina
United States	Roper Hospital	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

United States, 

Outcome

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