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

NCT02962882 | Completed Results

• 1 other identifier: PUP16_01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Conditions

Pressure Incidence Prevention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Wear Time (Days) for First Dressing

  4-6 days

Study Arms (2)

A. Mepilex Border Sacrum (Safetac)

EXPERIMENTAL

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

B. Mepilex Border Heel (Safetac)

EXPERIMENTAL

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

Interventions

Mepilex Border DEVICE

Multi-layer Foam Dressings

A. Mepilex Border Sacrum (Safetac); B. Mepilex Border Heel (Safetac)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (2)

Anmed Health

Anderson, South Carolina, 29621, United States

Location

Roper Hospital

Charleston, South Carolina, 29401, United States

Location

Results Point of Contact

• Title: Global Clinical Research Director
• Organization: Molnlycke Health Care

info@monlycke.com

+46 31 722 30 00

Study Officials

• Kelli Potter, BSN, RN

  AnMed Health Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: November 15, 2016
• Study Start: September 9, 2016
• Primary Completion: November 21, 2016
• Study Completion: May 4, 2017
• Last Updated: March 26, 2018
• Results First Posted: March 26, 2018

Record last verified: 2018-03

Locations

US (2)