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

Molnlycke Health Care

Status: Completed

Conditions: Pressure Incidence Prevention

Treatments: Device: Mepilex Border

Study type: Interventional

Funder types: Industry

Identifiers

NCT02962882

PUP16_01

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

A. Mepilex Border Sacrum (Safetac)

Experimental group

Description:

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).

Treatment:

Device: Mepilex Border

B. Mepilex Border Heel (Safetac)

Experimental group

Description:

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).

Treatment:

Device: Mepilex Border