Clinical trial NCT02962882: Pressure Injury Prevention in the ICU With Multi-Layer Foam Dressings
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Incidence Prevention
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2016-11-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 4-6 days
measure: 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
timeFrame: 4-6 days
Secondary outcomes:
measure: Wear Time (Days) for First Dressing
timeFrame: 4-6 days
Other outcomes:
Locations:
city: Anderson
country: United States
facility: Anmed Health
state: South Carolina
city: Charleston
country: United States
facility: Roper Hospital
state: South Carolina
Study officials:
affiliation: AnMed Health Medical Center
name: Kelli Potter, BSN, RN
role: PRINCIPAL_INVESTIGATOR
References: